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Feasibility of the trial procedures for a randomized controlled trial of a community-based peer-led wheelchair… Best, Krista L; Miller, William C; Routhier, François; Eng, Janice J Jul 17, 2017

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RESEARCH Open AccessFeasibility of the trial procedures for arandomized controlled trial of acommunity-based peer-led wheelchairtraining program for older adultsKrista L. Best1,2, William C. Miller3,5,6*, François Routhier1,2 and Janice J. Eng4,5,6AbstractBackground: A novel peer-led manual wheelchair (MWC) training program may support the training needs ofolder adults, but establishing program feasibility is a pragmatic first step. The purpose of this study was to evaluatethe feasibility of a peer-led Wheelchair training Self-Efficacy Enhanced for Use (WheelSeeU) program.Methods: Forty MWC users (mean age 65 years) were randomly assigned to the experimental (WheelSeeU) orcontrol group. Feasibility indicators of process, resources, management, and safety were collected throughout thestudy.Results: The consent rate was 49%. Participant retention rate was 90% post-intervention and 87.5% at follow-up(6 months). All participants reported perceived benefits from WheelSeeU. Participants and trainers adhered to thestudy protocol (>90%), and fidelity of the WheelSeeU intervention was attained (>90%). There were no adverseevents.Conclusions: WheelSeeU is an innovative and feasible approach for providing MWC training to older adults that isaccessible beyond initial rehabilitation without increased clinician burden. With minor modifications, it is feasiblethat WheelSeeU can be administered to older adults living in the community.Trial registration: NCT01838135.Keywords: Manual wheelchair, Older adults, Peer training, Rehabilitation, Self-efficacyBackgroundManual wheelchair (MWC) mobility is of particular con-cern among older adults (i.e., ≥65 years) who comprisemore than 50% of the wheelchair user demographic [1].Optimizing wheelchair skills can positively influencewheelchair use [2] and may reduce risk of accidents [3]and the mobility dependence of more than 50% of olderwheelchair users [4]. Although 5 h or less of manualwheelchair skills training effectively improves wheel-chair skills capacity when administered by a healthcareprofessional in rehabilitation or community contexts[5–8], older adults receive little to no wheelchair skillstraining [9, 10]. Results of a recent survey from a re-habilitation centre highlight this issue, as only 55% ofadults (~58 years of age) reported receiving wheelchairskills training before discharge. The remaining 45% didnot know of arrangements to receive any training afterdischarge [11].Wheelchair skills training facilitated by health careprofessionals during initial rehabilitation may be inhib-ited by clinician-perceived barriers of limited time andresources, clinicians’ skills and knowledge of wheelchairtraining, competing priorities during rehabilitation stays,and readiness for wheelchair use among patients [12, 13].Moreover, many older adults procure wheelchairs inde-pendently in the community (e.g., directly from vendors,* Correspondence: bill.miller@ubc.ca3The Department of Occupational Sciences and Occupational Therapy,Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada5The Rehabilitation Research Program, Vancouver Coastal Research Institute,GF Strong Rehabilitation Centre, Vancouver, BC, CanadaFull list of author information is available at the end of the article© The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Best et al. Pilot and Feasibility Studies  (2018) 4:18 DOI 10.1186/s40814-017-0158-3secondhand, or online) without clinical guidance andlikely do not receive any training at all. While community-based training programs may address issues related toscheduling, readiness, and procurement of wheelchairswithout the advice of a clinician, reliance solely on clini-cians to implement such programs may pose additionalburden and inferred healthcare costs.The concept of wheelchair use self-efficacy, defined asan individual’s belief in his or her ability to overcomechallenging situations when using a wheelchair [14], is apowerful mediator of use and participation in oldermanual wheelchair users [15, 16]. Self-efficacy, import-ant for adult learning, is enhanced when individualslearn from people they perceive to be similar to them-selves and who are managing similar situations [17].Therefore, implementing peers to facilitate interventionsmay provide an effective strategy for modeling wheel-chair use. A peer-led wheelchair training programshowed preliminary effectiveness for improving wheel-chair use self-efficacy and wheelchair skills in adultMWC users 19 years of age and older [18].Additional benefits of a peer-led program may includeincreased social interactions [19] or improved cost-effectiveness when compared to professional-led inter-ventions [20]. Moreover, peer-led wheelchair programsmay provide an avenue for fostering a needed con-tinuum of wheelchair skills training that starts duringinitial rehabilitation and continues after communityreintegration [18]. However, before proceeding withlarger effectiveness trials, it is critical to first evaluatethe feasibility of peer-led wheelchair training for olderadults [21]. Establishing feasibility will confirm key is-sues related to a study’s process and resources. Add-itionally, findings from feasibility studies can be usedto optimize the design of subsequent effectiveness trialsand judge appropriateness of proceeding with largertrials [21].Considering the need for community-based trainingfor older adult MWC users and the importance of estab-lishing feasibility, the purpose of this study was to evaluatethe feasibility of a peer-led wheelchair training programcalled “Wheelchair training Self-Efficacy Enhanced for Use(WheelSeeU)” [22].The specific study objectives were to evaluate thefeasibility according to the following indicators: (1)process issues: recruitment rate, consent rate, retentionrate, and perceived benefit; (2) resource issues: participantadherence, trainer adherence, burden of data collection,and translation of study materials; (3) management issues:participant processing time, combining data in Englishand French, study protocol administration, and fidelityof WheelSeeU intervention; and (4) safety: safety dur-ing the intervention and data collection (modifiedfrom [21]).MethodsA full description of the methods has been previouslypublished [22]. A brief description is detailed below.Minor modifications have been made to the study proto-col since the original publication, including the follow-ing: (1) Feasibility indicators for treatment response andvariation of outcomes were not reported in this feasibil-ity study and will be reported in a subsequent paper; (2)the eligibility criteria was revised from ≥55 to ≥50 yearsof age to increase the potential participant pool; (3)success on one the feasibility indicators for process (i.e.,recruitment rate) was modified from >90% acceptance to>20% acceptance to accurately reflect the reality of recruit-ment in rehabilitation research; and (4) the training proto-cols for the intervention and the control groups weremodified slightly to accommodate the need for individual-ized training if one of the participants missed a trainingsession.DesignA two-site randomized controlled trial (RCT) was com-pleted with community-dwelling MWC users in QuébecCity, QC, Canada, and Vancouver, BC, Canada.ParticipantsInclusion criteria ≥50 years of age Lived in the community Could self-propel a MWC an average of 1 h per day Had self-proclaimed wheelchair mobility goals Was cognitively able to engage in the WheelSeeUprogram (Modified Mini-Mental Status Exam(MMSE) score of ≥24) [23]Exclusion criteria Unable to complete study questionnaires in Englishor French Had anticipated health conditions or proceduresthat contraindicate training (e.g., surgery that mayimpair physical activity) Had degenerative conditions that were expected toprogress quickly (e.g., amyotrophic lateral sclerosis) Were receiving or planning to receive wheelchairmobility training during the study periodRecruitmentRecruitment took place between October 2013 andMarch 2016 using the following recruitment strategies:database of existing wheelchair users, clinicians, andvendors described the study to inpatients and outpatientsat a local rehabilitation centre; posters and presentationsgiven to special interest groups in the community; mail-Best et al. Pilot and Feasibility Studies  (2018) 4:18 Page 2 of 12outs to potential participants as identified by hospital re-cords; social media (i.e., Facebook page); and word-of-mouth. The protocol for this study was approved by theResearch Ethics Boards at the University of BritishColumbia, Institut de réadaptation en déficience physiquede Québec, and Vancouver Coastal Health in Vancouver.All study participants provided informed consent.Randomization and concealmentThe randomization procedure was designed by an offsitestatistician and consisted of stratification by site usingblock sizes of four or six (to allow for randomization ofpairs of participants). When two participants were en-rolled, the Tester completed baseline data collection andentered data into a secure database. The Site Coordin-ator then contacted the statistician to obtain group as-signment for the pair of participants within 48 h. TheSite Coordinator forwarded participant contact informa-tion to the appropriate group trainer (i.e., interventionor control group), who contacted both participants toschedule six training sessions. Therefore, randomizationwas concealed from the Tester at all time points.Intervention and control groupsThe WheelSeeU intervention consisted of six (~weekly),1.5-h wheelchair training sessions delivered by a peer-trainer and a support-trainer to two wheelchair users.Peer-trainers who were ≥45 years of age, who had at least5 years of experience using a wheelchair (with intermedi-ate to advanced wheelchair skills), and support-trainerswho had at least 5 years of clinical experience were re-cruited and trained in a 2-day workshop (~15 h) led by astudy investigator (KB).WheelSeeU incorporated tasks known to challengewheelchair use self-efficacy (e.g., navigating a MWC inthe community, completing activities in a MWC, man-aging social situations in a MWC [14]), but each sessionwas individualized according to participant-definedgoals. After introductions, the peer-trainer gave a briefpresentation outlining expectations of WheelSeeU. Thepeer-trainer explained the SMART goal framework [24],then worked with participants at the beginning ofWheelSeeU to define MWC mobility or participation-oriented goals. Goals were recorded, progression wasmonitored, and participants were encouraged to set newgoals as their skills progressed. The peer-trainer andsupport-trainer worked together to break the goals intosmaller task objectives (and to identify potential bar-riers), which helped them to form the training plan foreach session. The task objectives were built into practice,as well as methods for overcoming barriers. The peer-trainer provided verbal instruction, demonstration, andfeedback to participants (with help from the support-trainer when necessary). The peer-trainer debriefed theparticipants at the end of each session to recap goalsand discussed how to integrate new skills into practicein the community and at home (i.e., provided home-work). The peer-trainer took note of the participants’homework, which formed the initial discussion for thenext session. The support-trainer provided spotting dur-ing the practice of skills and intervened immediately ifthere was unsafe wheeling that could lead to tips or falls.The future intent of WheelSeeU is that it will be adminis-tered by a peer-trainer, with spotting provided by care-givers, family members, volunteers, or clinician assistants.However, given that this is a feasibility study of a novelintervention, it was prudent to ensure participant safetythrough the inclusion of a clinician support-trainer.Participants in the control group received six(~weekly) 1.5-h didactic sessions of information aboutusing a wheelchair in the community (iWheel) led by ahealth care professional. The iWheel protocol, createdspecifically for this study, was designed to control for at-tention without providing any wheelchair skills training(available at http://millerresearch.osot.ubc.ca). Each ses-sion started with an “icebreaker” activity (e.g., “MWCJeopardy,” “Describe your dream vacation”), and then,information (and embedded questions) were presentedon six topics: (1) accessible places in the community(e.g., How do you determine whether a place is access-ible prior to going there?); (2) transportation (e.g., De-scribe your experiences using public transportation/trains/ ferries/ airplanes?); (3) MWC set-up and main-tenance (e.g., What regular maintenance do you do onyour MWC?); (4) using computers (e.g., How do you usethe internet?); (5) pain and fatigue management (e.g.,What do you do to manage pain/ fatigue?); and (6) Phys-ical activity and nutrition (e.g., What physical activitiesdo you take part in using your MWC?). Pre-formattedquestions were integrated to reduce the likelihood ofspontaneous discussions about wheelchair skills amongparticipants. A health care or research professional withat least 2 years of experience in rehabilitation researchcompleted 6 h of iWheel training facilitated by a studyinvestigator (KB). The iWheel trainer was instructed notto give any MWC skills training or advice on how to usea MWC in a better way.Outcomes to assess feasibilityFeasibility indicators for process, resources, management,and safety parameters were measured during study admin-istration and at study end.Process indicatorsRecruitment rate—The recruitment rate was defined asthe number of participants recruited per month. This in-formation was recorded in the study log.Best et al. Pilot and Feasibility Studies  (2018) 4:18 Page 3 of 12Consent rate—The consent rate was calculated by div-iding the number of individuals who met inclusion cri-teria, by the number who consented to participate in thestudy. A research coordinator recorded the reasons whyeligible individuals were not interested in participatingin the study log.Retention rate—The retention rate was calculated bydividing the number of participants, who completed datacollection at T2 and T3, by the number of participantswho completed data collection at T1.Perceived benefit—Participant perceived benefit of theintervention was assessed using a study-specific surveythat asked participants if they felt WheelSeeU had anybenefits towards using a MWC.Resource indicatorsParticipant adherence—Adherence to the study wasassessed by tracking the total number of WheelSeeUand iWheel sessions attended by participants. Thetrainers recorded participant adherence in a study log.Trainer recruitment and adherence—The ability to re-cruit and maintain a peer-trainer (i.e., trainer adherence)was assessed by tracking the total number of WheelSeeUsessions attended by the peer-trainer.Participant and tester burden—Burden was measuredby the amount of time it took to administer study out-comes at T1, T2, and T3. The tester recorded this dataat each time point.Data collection commenced in October 2013 and wascompleted in October 2016.Descriptive variablesSociodemographic and personal information (i.e., age,sex, marital status, highest level of education, cognition,primary diagnosis related to MWC use, length of timeusing the MWC, propulsion method, depression (Hos-pital Anxiety and Depression Scale (HADS) [25]), andsocial support (Interpersonal Support Evaluation List(ISEL) [26]) were collected at baseline.Clinical outcome measures:The proposed primary outcome for the main trial,wheelchair skills capacity, was assessed objectively usingthe Wheelchair Skills Test (WST) [27] at baseline (T1),post-intervention (T2), and 3-month follow-up (T3).Secondary clinical outcomes were also collected for themain trial at the three time points and included subject-ive wheelchair skills capacity and performance and safety(Wheelchair Skills Test Questionnaire (WST-Q) [28]),wheelchair use self-efficacy (Wheelchair Use ConfidenceScale [29]), life-space mobility (Life-Space Assessment(LSA) [30]), satisfaction with participation (WheelchairOutcome Measure (WhOM) [31]), quality of life (Late-life Function and Disability Index (LLFDI) [32]), andhealth utility (Health Utility Index (HUI) [33]). However,only preliminary results of the primary clinical outcome(objective wheelchair skills capacity) are reported inthis paper. Clinical outcomes have been described pre-viously [22], and results will be presented in a separatemanuscript.Ability to translate/complete study in English andFrench—Based on monthly meetings among study inves-tigators and research coordinators, the ability to translateand complete the study protocol was gauged throughsubjective evaluation (i.e., yes or no).Management indicatorsParticipant processing time—Participant processing timewas defined as the total number of days from initial con-tact to study enrolment. Details on processing time wererecorded in the study log by the research coordinator.Ability to combine data—The ability to combine thedata was gauged through subjective evaluation of studyinvestigators.Administration of study protocol—To ensure theprotocol was administered as intended (i.e., training wascompleted with pairs of participants by a peer-trainerand a support-trainer), study protocol administrationwas guided by a protocol checklist. The checklist wasmonitored and recorded by the support-trainer and con-trol group trainer.Fidelity—Intervention fidelity, defined as adherent andcompetent delivery of the intervention, was evaluatedusing a study-specific WheelSeeU Administrator RatingForm that outlined important details and components ofthe WheelSeeU intervention to be completed by thepeer-trainer and the support-trainer in a checklist (e.g.,support-trainer demonstrated proper application of thespotter strap, peer-trainer helped to develop new goalsand reviewed existing goals with participants). A re-search coordinator at both sites completed the Wheel-SeeU Administrator Rating Form randomly, at leastone time per participant pair during the WheelSeeUintervention.SafetyIntervention—Intervention safety was measured by thenumber of adverse events that occurred during theWheelSeeU intervention (e.g., tips, falls, cuts, abrasions,blisters). The support-trainer was responsible for docu-menting any adverse events.Data collection—Safety during data collection wasassessed by the number of adverse events that occurredduring testing procedures. The tester was responsible forrecoding any adverse events that occurred during datacollection.AnalysisDescriptive statistics (mean, standard deviation (SD),counts (percentage)) were used to summarize continuousBest et al. Pilot and Feasibility Studies  (2018) 4:18 Page 4 of 12and categorical data as appropriate. Feasibility indicatorsfor process, resources, management, and treatment weretreated as binary (i.e., successful, unsuccessful). “Success-ful” indicated that the protocol is sufficiently robust tomove forward with a large RCT with only small or noadaptation to the protocol required, while “unsuccessful”indicated a need for changes to the protocol beforeproceeding.Sample size was calculated a priori using variabilitydata (mean (SD)) of the WST from three randomizedcontrolled trials [22]. According to Campbell et al. [34],a sample size of 40 is large enough to represent the tar-get population and to evaluate feasibility indicators.ResultsThe flow of participants through the WheelSeeU studyis described in Fig. 1.Participants had a mean (SD) age of 64.5 (8.0) years,predominantly male (60%), with primary diagnoses ofamputation (28%), spinal cord injury (20%), and otherconditions (e.g., multiple sclerosis, stroke, Parkinson’sdisease, post-polio) (52%), and had a mean (SD) of 7(11.3) years of previous experience using a manualwheelchair. Table 1 provides sample characteristics andbaseline demographic information. The groups were rea-sonably well balanced after randomization, but the inter-vention group reported a higher level of depression andthe control group had more years of previous wheelchairexperience.Summary of clinical outcomes (baseline)Summary statistics (i.e., mean (SD)) of primary and sec-ondary clinical outcomes for the intervention and con-trol groups at baseline are presented in Table 2. Afterrandomization, the intervention group had slightly lowermean scores on all clinical outcomes compared to thecontrol group.Feasibility indicatorsSuccess was achieved on 10 of 13 feasibility indicators.Definitions of feasibility indicators and a priori parame-ters for success are defined in Table 3.Process indicatorsRecruitment rate—It took 18 months to recruit 40 par-ticipants, at a rate of approximately one participant permonth per site. However, recruitment rate was higher inQuebec (approximately two participants per month)compared to that in Vancouver (approximately two par-ticipants every 4 months).Consent rate—A 49% consent rate was attained. Of the120 participants contacted, 39 did not meet the inclu-sion criteria. Forty-one were not interested, and 40 gavetheir consent to participate in the study.Fig. 1 Flow of participants through the WheelSeeU studyBest et al. Pilot and Feasibility Studies  (2018) 4:18 Page 5 of 12Retention rate—Forty individuals completed T1 assess-ments. The overall participant retention was 95% atT2 and 87.5% at T3. Of the 18 participants allocatedto the experimental group, one was lost to follow-upat T2 and two more were lost to follow-up at T3.One participant withdrew from the study after twoWheelSeeU sessions due to health reasons unrelatedto the study and died shortly after. The other twoparticipants were hospitalized after the completion ofWheelSeeU for reasons unrelated to the study. Ofthe 22 participants allocated to the control group,one was lost to follow-up at T1 and one more waslost to follow-up at T3. One participant withdrewfrom the study after one iWheel session due to anunforeseen emotional issue associated with returningto the rehabilitation centre. The other participantdied before completing T3 due to reasons unrelatedto the study.Table 1 Demographic, wheelchair-related, and clinical variables at baselineParticipant characteristics WheelSeeU (n = 18) Control(n = 22)Demographic and personal informationAge, year, mean (SD); range 66.2 (7.0); 54–83 63.1 (8.7); 50–84Sex, no. (%)Male 7 (39) 17 (77)Marital status, no. (%)Married or common law 10 (56) 11 (50)Education, no. (%)College or university 15 (83) 16 (73)Income CAD, no. (%)<15,000 1 (5) 5 (23)15,000–50,000 8 (44) 8 (36)Primary language, no. (%)English 4 (22) 10 (45)Primary diagnosis, no. (%)Spinal cord injury 3 (17) 5 (23)Amputation 3 (17) 8 (36)Other (MS, stroke, Parkinson’s, post-polio) 12 (67) 9 (41)Wheelchair-related variablesPrevious MWC use, year, mean (SD); range 4.3 (5.5); 0–22 9.0 (14.0); 0–45Use in current MWC, year, mean (SD); range 2.8 (5.3); 0–22 1.3 (2.0); 0–10Use MWC dailyYes 14 (78) 17 (77)Propulsion method, no. (%)2 hands only 16 (89) 17 (77)Hours per day spent in MWC, no. (%)>8 6 (33) 8 (36)5–8 4 (22) 3 (13)WC-related accident in the past year, no. (%)Yes 2 (11) 1 (5)Clinical variables at baselineMMSE, mean (SD); range [max score 30] 28.2 (1.3); 26–30 28.8 (0.9); 27–30ISEL, mean (SD); range [max score 18] 10.5 (5.3); 3–18 15.6 (3.6); 7–18HADS anxiety, mean (SD); range [max score 21] 6.5 (6.4); 0–16 4.0 (2.4); 0–7HADS depression, mean (SD); range [max score 21] 7.3 (3.4); 4–12 2.0 (1.3); 1–4MMSE The Mini-Mental State Examination, ISEL Interpersonal Support Evaluation List, HADS Hospital Anxiety and Depression ScalesBest et al. Pilot and Feasibility Studies  (2018) 4:18 Page 6 of 12Perceived benefit—100% of participants who completedthe WheelSeeU intervention felt that they received bene-fits for using a MWC from the WheelSeeU trainingprogram.Resource indicatorsParticipant adherence—Participant adherence to theintervention was high in both groups. Not including par-ticipants who dropped out of the study (n = 5), 95% ofparticipants allocated to the WheelSeeU interventiongroup and 90% of participants in the control group com-pleted six of six training sessions. One participant in theintervention group completed five of six WheelSeeU ses-sions, while two participants in the control group com-pleted five of six iWheel sessions. All others completedsix of six sessions.Trainer recruitment and adherence—A total of threepeer-trainers were recruited and trained. The three peer-trainers (all males with spinal cord injury), who were53.3 ± 10.0 years of age and had 20.3 ± 17.1 years of ex-periencing using a MWC, completed the WheelSeeUtraining. While an existing skill set was not a prerequis-ite for selecting peers, the peer-trainers in this study hadvarious skills that may have influenced their competencyfor wheelchair training (e.g., athletic backgrounds, motiv-ational speaking, coaching, teaching, and peer-mentorshipexperience). Three support-trainers (two occupationaltherapists, one kinesiologist), with 9.3 ± 1.5 years of clin-ical experience with MWC users, provided support to thepeer-trainers. Of the 108 WheelSeeU sessions, one peer-trainer missed two sessions that were completed by thesupport-trainer.Participant and tester burden—The burden of datacollection was higher than anticipated, with mean (SD)testing times of 141 (36) min at T1, 119 (43) min at T2,and 118 (56) min at T3.Ability to translate/complete study in English andFrench—There were no issues with translating or admin-istering study materials in English or French.Management indicatorsParticipant processing time—The mean (SD) subjectprocessing time was 74 (80) days, which did not meetthe criterion for success.Ability to combine data—There were no issues withcombining the English and French data.Administration of study protocol—Successful admin-istration of the study protocol was also achieved at bothsites. Minor issues were addressed at monthly teammeetings, such as how to proceed if a participant ortrainer missed a training session. In both cases, thestudy proceeded with one participant and one trainer.A change to the protocol was made in one circum-stance when one participant in the control groupdropped out of the study before completion of the con-trol group didactic sessions. It was decided to completethe sessions with the control group trainer and oneparticipant only.Table 2 Baseline summaries of primary and secondary clinical outcomesClinical outcomes Intervention group (n = 18)Mean (SD)Control group (n = 22)Mean (SD)WST (max score 100)Objective wheelchair skills capacity 66.0 (13.3) 71.6 (11.4)WST-Q (max score 100)Subjective wheelchair skills capacity 67.0 (15.7) 76.1 (10.0)Subjective wheelchair skills performance 45.5 (20.7) 56.3 (17.3)WheelCon (max score 100)Wheelchair use self-efficacy 65.9 (22.7) 79.6 (13.8)WhOM (max score 100)Satisfaction with participation 55.3 (24.8) (n = 17) 62.9 (27.2) (n = 21)LSA (max score 120)Life-space mobility 34.9 (21.0) 44.7 (22.9)LLFDI (max score 100)Participation frequency 49.5 (9.1) 53.5 (11.7)LLFDI (max score 100)Instrumental role 34.3 (9.9) 44.0 (12.3)WST Wheelchair Skills Test, WST-Q Wheelchair Skills Test Questionnaire, WheelCon Wheelchair Use Confidence Scale, WhOM Wheelchair Outcome Measure,LSA Life-Space Assessment, LLFDI Late-Life Function and Disability IndexBest et al. Pilot and Feasibility Studies  (2018) 4:18 Page 7 of 12Table3Descriptionoffeasibilityindicators,parametersforsuccess,results,andsuggestedmodificationsFeasibilityindicatorOutcomemeasureParameterforsuccessResultsFeasibleSuggestedmodificationsProcess(n=4)Recruitmentrate#ofsubjectsrecruited/time2subjects/month/site1subject/m/siteNConsiderotherrecruitmentstrategiesConsentrate%ofsubjectsconsenting>20%acceptance49%acceptanceYRetentionrate%ofsubjectswithcompletedatacollection(T2,T3)CompleteT2andT3with≥80%ofsubjectsT2=95%T3=87.5%YPerceivedbenefitPost-interventionparticipantquestionnaire>85%willperceivebenefitofWheelSeeU100%YResources(n=4)ParticipantadherenceWheelSeeUgroupComplete6WheelSeeUsessions>85%ofsubjects95%YControlgroupComplete6iWheelsessions>85%ofsubjects90%YTraineradherencePeer-trainerRecruit/retainpeer-trainersAttend6×5sessions98%YSupport-trainerRecruit/retainsupport-trainersAttend6×5sessions98%YDatacollectionburdenT1DatacollectiontimeT1>85%ofsubjectscompletein≤2h141(36)minNReducethenumberofoutcomemeasurescollectedT2DatacollectiontimeT1>85%ofsubjectscompletein≤1.5h119(43)minNRelaxparameterforsuccessT3DatacollectiontimeT1>85%ofsubjectscompletein≤1.5h118(56)minNTranslationsTranslateandadministerstudymaterialsinEnglishandFrenchNoissues0issuesYManagement(n=4)ProcessingtimeTimebetweeninitialsubjectcontacttoenrolmentMeantimeis<10daysNRelaxparameterforsuccessCombiningdataSuccessfullycombinedatainEnglishandFrenchNoissues0issuesYStudyprotocoladministrationStudyprotocolchecklistModificationscanbemadewithminimalchangestoprotocolMinimalchangeYAllowforindividualtrainingifonesubjectdropsoutInterventionfidelityObserveandscorepeer-trainerandexperttraineradminis-tertheintervention>90%onWheelSeeUAdministratorRatingForm90%YSafety(n=1)Intervention#ofadverseeventsNoadverseevents0adverseeventsYDatacollection#ofadverseeventsNoadverseevents0adverseeventsYBest et al. Pilot and Feasibility Studies  (2018) 4:18 Page 8 of 12Fidelity—The WheelSeeU Administration Rating formwas completed by research coordinators at both sites on sixseparate occasions. A mean (SD) score of 90 (5)% revealedthat fidelity of the WheelSeeU intervention was attained.One issue that was raised at both sites was that the support-trainer took more of a lead role than intended during thefirst few WheelSeeU sessions. As the peer-trainer gained ex-perience and felt more comfortable and confident in theirrole, they began to take on the lead role as was intended.SafetyIntervention—The WheelSeeU protocol was safe for par-ticipants, as there were no adverse events in deliveringthe WheelSeeU intervention.Data collection—There were no adverse events duringdata collection.There was one adverse incident with the peer-trainerduring the WheelSeeU intervention, which did not resultin injury or serious concern. The peer-trainer tippedbackwards in his wheelchair during demonstration ofone of the skills and used the opportunity to teachlearners about safe falling techniques.DiscussionThe results of this study confirm that the peer-ledWheelSeeU study protocol was feasible to administer tocommunity-living older adults. Following minor modifi-cations to address three feasibility issues (recruitmentrate, burden of data collection, and subject processingtime), findings support conducting a larger clinical trialto evaluate the effectiveness of peer-led WheelSeeUtraining for older adults in the community.ProcessFurther consideration of how to best target oldercommunity-living adults who use MWCs may improvefeasibility for recruiting older adults MWC users. About6 months into recruiting, the eligibility criteria wereslightly revised from ≥55 to ≥50 years of age to increasethe potential participant pool. Revising eligibility criteriawithout reducing scientific rigor has been suggested asone approach for recruiting wheelchair users [35]. Al-though the WheelSeeU study used various creative re-cruitment strategies at both sites to target wheelchairusers, as suggested by Nary et al. [35], recruitment poseda challenging issue. Recruitment methods in Vancouverincluded clinicians and vendors describing the study toinpatients and outpatients at a local rehabilitationcentre, posters, and presentations to special interestgroups in the community, and mail-outs to potentialparticipants as identified by hospital records. Althoughwe tried to reach additional participants through wheel-chair vendors in the community, there was some reluc-tance to ‘push’ a product that was not being sold by thecompany. All 26 participants in Québec City were iden-tified and recruited by a clinician through a database ofwheelchair users at the Institut de réadaptation endéficience physique de Québec, which may explain whyrecruitment rates were higher in Québec City comparedto Vancouver. More research is needed to determinebest methods for recruiting older community-livingwheelchair users.Although a 49% consent rate is considered very highin rehabilitation research, recruitment issues identifiedin this study suggest that recruiting participants duringinitial rehabilitation may not be the best time for inter-mediate or advanced MWC training. In addition toclinician-perceived barriers of conducting wheelchairskills training during rehabilitation [12], issues of com-peting priorities, physical and psychological adjustmentsto mobility impairment, and lack of real-world experi-ences with using a wheelchair may influence the likeli-hood of new MWC users to participate. Therefore,community-based training programs like WheelSeeUmay be better suited for older adults after they have hadsome time to experience the task demands of MWC usein the community.It is promising that participant retention was high atboth time points (95% at T2 and 87.5% at T3) in boththe experimental and control groups. All participantswho completed the WheelSeeU intervention felt theybenefited from the training, which has prompted the de-sign of a qualitative study to obtain richer data aboutparticipants’ experiences and perceptions with a peer-ledMWC training program. The WheelSeeU study used anactive control group (iWheel) in efforts to increase par-ticipant adherence, which seemed to be well received byparticipants. While having an active control group mayhave been a less pragmatic approach in the evaluation ofa novel intervention, this approach minimized threats tointernal validity by controlling for researcher attentionand travel to sessions [36].ResourcesThe burden of data collection was higher than anticipated;however, no participants indicated issues with testingtimes. In fact, comments were made about enjoying thetime with the tester in many cases. Participant and testerburden may be reduced through elimination of the object-ive WST from the protocol, which takes approximately30 min to complete. Although WST-Q scores are highlycorrelated with objective WST scores [28], the WST-Qmay be a more valid indication of wheelchair skills cap-acity because participants are not penalized for technicaltesting errors (e.g., touching the line). Additionally, col-lecting only the participation component of the LLFDImay further reduce testing by 15–20 min. Since Wheel-SeeU targets improved MWC mobility for the purpose ofBest et al. Pilot and Feasibility Studies  (2018) 4:18 Page 9 of 12increasing participation outcomes, future trials shouldconsider patient-reported outcomes to fully understandthe impact of WheelSeeU [37].It is promising that both participant and peer-traineradherence to the intervention was high. Although allparticipants stated perceived benefits of WheelSeeU, theexact reasons for adherence are unknown. Qualitativeinterviews with participants who completed WheelSeeUmay provide considerable insight about perceived facili-tators and barriers influencing adherence and the im-portant characteristics of peer-trainers (e.g., age, gender,previous experiences) that may inform the developmentof future studies and sustainable community-based pro-grams. Qualitative interviews with participants in thecontrol group may have provided useful informationabout the “attention-control” activity. The iWheel ses-sions provided participants with social activity and withresources about their community, which may have hadpotential perceived benefits for participants. Finally,qualitative interviews with those who accept and declineto participate in intervention research may also providea better understanding of how to recruit MWC users forcommunity-based programs. Findings from this studyalso support the feasibility of recruiting and maintaininga peer-trainer, which may positively contribute to thesustainability of community-based wheelchair trainingprograms in the future.It is plausible that peer-led MWC training may be de-livered to larger groups of MWC users in the commu-nity without the need for clinician presence, thusmaximizing resources and potentially decreasing costs.However, prior to this, it is prudent to ensure that peer-trainers have the necessary characteristics and skill sets.This feasibility study allowed us to gain insight on someof the important characteristics of a peer-trainer (e.g.,previous coaching/ peer-mentorship/teaching experi-ence, wheelchair skills, wheelchair use confidence), thussuggesting prerequisites for future recruitment of peer-trainers. With the right peer-trainers, it is possible thatclinicians or MWC training experts could be consultedas required. The feasibility nature of this study allowedus to explore the important characteristics of peer-trainers. However, due to pragmatic reasons (i.e., slowrecruitment) and to maximize safety, the trainer to par-ticipant ratio was 2:2.ManagementWhile success on subject processing time was notachieved, the fact that participants remained interestedin the study after a period of approximately 3 months ispromising. For participants who were contacted during arehabilitation stay, regular contact was maintained be-tween the initial screening and enrolment [35]. This alsohighlights the importance of providing wheelchairtraining at times that are convenient for participants andsupports the necessity for wheelchair training that con-tinues after discharge from initial rehabilitation.Intervention fidelity is critical to knowledge translationof evidence-based programs. With ~15 h of training,older MWC users and clinicians were able to administera self-efficacy enhanced wheelchair training program.However, in some cases, the support-trainer took moreof a lead role in the training than was intended. As thepeer-trainer gained experience and felt more comfort-able and confident in their role, they began to take tolead as intended. As stated by Green [38], this reinforcesthe importance of peer-selection and ensuring peers re-ceive adequate training. Although the current WheelSeeUprogram was co-led by a peer-trainer and a support-trainer, the future intent of WheelSeeU is to provide apeer-led program without the need for a healthcare pro-fessional. Future studies of peer-led wheelchair trainingshould also consider ecological validity and the inability tocontrol all protocol parameters in a real-world applicationof WheelSeeU. It has been suggested that tradeoffs be-tween maintaining experimental control and fidelity ofevidence-based programs maximizing fit to the new con-text should be considered in research among individualswith disabilities [39].SafetyFindings from this study confirm that a wheelchair train-ing program administered by a peer and a health careprofessional is safe. However, as previously mentioned,the future intent of WheelSeeU is to be solely adminis-tered in the community by a peer-trainer. Recent findingsfrom focus groups conducted during the development of apeer-led program highlight some concern for programsled solely by lay peers [40], but there is evidence that sup-ports competencies of peer-trainers when adequate train-ing is provided [41]. Moreover, community-living MWCusers should be given the autonomy and choice to makedecisions about how they participate in community-basedprograms.LimitationsThe consent rate (49%) was based on the number of in-dividuals contacted by research investigators during thestudy period. This number may be underestimated, asthere is no way to track the number of people who mayhave been contacted through snowball methods or byworld-of-mouth from clinicians who were not a part ofthe study team.There may have been pragmatic issues with slow enroll-ment and an intervention designed for dyadic training. Inorder to perform the most robust randomization proce-dures (i.e., group allocation upon completion of baselinemeasures), while reducing the chances of dropout due toBest et al. Pilot and Feasibility Studies  (2018) 4:18 Page 10 of 12long wait periods between baseline testing and start of theintervention period, randomization was done in blocks oftwo. This means that as two participants were enrolled,they were allocated in pairs to either the intervention orthe control group. Restricting training to pairs of partici-pants was recognized as a limitation in this study. Futurestudies may consider one-on-one training or training insmall groups.While assessing peer-trainer adherence was an a prioriobjective, we did not include support-trainer or iWheeltrainer adherence as a study objective. Both the support-trainer and iWheel trainer were part of the extended re-search team and maintained regular contact with thestudy investigators, including attending bimonthly teammeetings to ensure any concerns could be addressed asthey arose. Details about support-trainer and iWheeltrainer adherence may have provided useful informationpertaining to this study and should be considered forfuture feasibility studies.Finally, details about peer-trainer training and inter-vention fidelity may have strengthened the results of thisstudy. Implementation of a test at the end of the 2-daytraining session may help to ensure the peer-trainer andsupport-trainer are prepared to administer the interven-tion. However, study investigator (KB) has more than10 years of experience in wheelchair skills training andthus should be able to attest to trainer readiness. Add-itionally, the WheelSeeU Administrator Rating formcould have been administered more frequently to under-stand fully how WheelSeeU was delivered and whetherit was administered as intended. Specifically, more infor-mation on how the lead roles shifted from the support-trainer to the peer-trainer would provide more insightinto factors that may be taken into consideration whentraining the peer-trainer. It is possible that an additionalday of training would have been useful for practice. It ispossible that WheelSeeU sessions could be videotaped;however, it was felt that this could hinder organicdiscussions.ConclusionsSelf-efficacy enhanced peer-led wheelchair training providesa feasible option that may contribute to the development ofa needed community-based wheelchair training continuumfor older wheelchair users. The present study demonstratesthat with the support of a clinician, it is feasible for peers toteach older MWC users about using their wheelchair.Further examination of the efficacy of community-basedpeer-led programs in a larger randomized controlled trialis warranted.AbbreviationsiWheel: Information for using a wheelchair; MWC: Manual wheelchair;RCT: Randomized controlled trial; SD: Standard deviation;WheelSeeU: Wheelchair training Self-Efficacy Enhanced for UseAcknowledgementsWe would like to thank our peer-trainers (Jurek Golas, Richard Peter, and MichelGarant), support-trainers (Marie-Pierre Johnson, Megan MacGillivray), and controlgroup trainers (Emma Smith and Emilie Lacroix) for administering the studyprotocol. We would also like to thank Dr. Charles Goldsmith and Dr. JeanLeblond for their statistical advice and support. We would like to acknowledgethe contributions of Dr. Kate Keetch, Ms. Emilie Lacroix, and Ms. NaomiBartz-McCormick for the study coordination, logistics, data collection, translatingthe documents between French and English, and help in preparing thefinal manuscript. Finally, we would like to acknowledge the support andscholarly inspiration from the members of the Canadian Disability ParticipationProject (www.cdpp.ca) mobility squad.FundingThis project was funded by the Canadian Institutes for Health Research.Salary support was provided to Dr. Krista Best by Fonds de Recherche duQuébec–Santé (FRQS) and to Dr. François Routhier by the FRQS ResearchScholar Award.Availability of data and materialsData and materials used and/or analyzed during the current study areavailable from the corresponding author on reasonable request.Authors’ contributionsKB conceptualized the WheelSeeU and iWheel intervention, designed thestudy protocol, assisted in obtaining the project funds, provided training tothe trainers and support staff, performed the data synthesis and analysis, anddrafted the manuscript. WM conceptualized the intervention, participated inthe design of the study, obtained the project funds (primary investigator),managed the overall project and the Vancouver site, assisted in the dataanalysis, and contributed to the final manuscript. FR participated in thedesign of the study, managed the Quebec site, assisted in the data analysis,and contributed to the final manuscript. JE provided the mentorship inconducting the clinical trials, assisted in the design of the study, andcontributed to the data synthesis and the final manuscript. All authors readand approved the final manuscript.Competing interestsThe authors declare that they have no competing interests.Consent for publicationNot applicable.Ethics approval and consent to participateThe protocol for this study was approved by the Research Ethics Boards atthe University of British Columbia, Institut de réadaptation en déficiencephysique de Québec, and Vancouver Coastal Health in Vancouver. All thestudy participants provided informed consent.Publisher’s NoteSpringer Nature remains neutral with regard to jurisdictional claims inpublished maps and institutional affiliations.Author details1Department of Rehabilitation, Université Laval, Quebec City, QC, Canada.2Center for Interdisciplinary Research in Rehabilitation and Social Integration,Centre integré de santé et de services sociaux de la Capitale-Nationale,Institut de réadaptation en déficience physique de Québec, Quebec City, QC,Canada. 3The Department of Occupational Sciences and OccupationalTherapy, Faculty of Medicine, University of British Columbia, Vancouver, BC,Canada. 4The Department of Physical Therapy, Faculty of Medicine, Universityof British Columbia, Vancouver, BC, Canada. 5The Rehabilitation ResearchProgram, Vancouver Coastal Research Institute, GF Strong RehabilitationCentre, Vancouver, BC, Canada. 6Rehabilitation Research Lab, UBCDepartment of Occupational Science & Occupational Therapy, Vancouver, BC,Canada.Best et al. 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Med Care. 2001;39(11):1217–23.•  We accept pre-submission inquiries •  Our selector tool helps you to find the most relevant journal•  We provide round the clock customer support •  Convenient online submission•  Thorough peer review•  Inclusion in PubMed and all major indexing services •  Maximum visibility for your researchSubmit your manuscript atwww.biomedcentral.com/submitSubmit your next manuscript to BioMed Central and we will help you at every step:Best et al. Pilot and Feasibility Studies  (2018) 4:18 Page 12 of 12


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