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Development and pilot test of a peer-support based Cardiac-Diabetes Self-Management Program: A study… Wu, Chiung-Jung J; Chang, Anne M; Courtney, Mary; Shortridge-Baggett, Lillie M; Kostner, Karam Apr 11, 2011

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STUDY PROTOCOL Open AccessDevelopment and pilot test of a peer-supportbased Cardiac-Diabetes Self-ManagementProgram: A study protocolChiung-Jung Jo Wu1*, Anne M Chang1,2, Mary Courtney3, Lillie M Shortridge-Baggett4 and Karam Kostner2,5AbstractBackground: People with cardiac disease and type 2 diabetes have higher hospital readmission rates (22%)compared to those without diabetes (6%). Self-management is an effective approach to achieve better healthoutcomes; however there is a lack of specifically designed programs for patients with these dual conditions. Thisproject aims to extend the development and pilot test of a Cardiac-Diabetes Self-Management Programincorporating user-friendly technologies and the preparation of lay personnel to provide follow-up support.Methods/Design: A randomised controlled trial will be used to explore the feasibility and acceptability of theCardiac-Diabetes Self-Management Program incorporating DVD case studies and trained peers to provide follow-upsupport by telephone and text-messaging. A total of 30 cardiac patients with type 2 diabetes will be randomised,either to the usual care group, or to the intervention group. Participants in the intervention group will received theCardiac-Diabetes Self-Management Program in addition to their usual care. The intervention consists of three face-to-face sessions as well as telephone and text-messaging follow up. The face-to-face sessions will be provided by atrained Research Nurse, commencing in the Coronary Care Unit, and continuing after discharge by trained peers.Peers will follow up patients for up to one month after discharge using text messages and telephone support.Data collection will be conducted at baseline (Time 1) and at one month (Time 2). The primary outcomes includeself-efficacy, self-care behaviour and knowledge, measured by well established reliable tools.Discussion: This paper presents the study protocol of a randomised controlled trial to pilot evaluates a Cardiac-Diabetes Self-Management program, and the feasibility of incorporating peers in the follow-ups. Results of thisstudy will provide directions for using such mode in delivering a self-management program for patients with bothcardiac condition and diabetes. Furthermore, it will provide valuable information of refinement of the interventionprogram.Trial Registration NumberACTRN12611000086965BackgroundCardiac disease and diabetes are the most prevalentchronic diseases in the Australian population. The num-ber of people with diabetes is estimated to increasefrom 171 million in 2000 to 366 million by 2030 [1,2].The prevalence of diabetes for Australians aged 25 orover in 1999-2000 was 7.4% (more than 1 in 14 people)and the average age of people with diabetes is gettingyounger [3]. In 2000-2003, it is reported that 6.6% ofAustralians aged 18 years and over had diabetes [3].Australia’s Health 2008 confirmed people diagnosedwith type 2 diabetes are more vulnerable to cardiovascu-lar complications, and are at greater risk of further car-diac events, leading to poor health-related quality of life[3]. People with diabetes were reported to rate theirhealth three times lower than those without diabetes[3,4]. The direct costs of treating type 2 diabetes and itsrelated complications is estimated to reach between$213-396 billion a year globally by 2025, which is ashigh as 40 percent of some countries’ health care bud-gets [5-9]. Therefore, reducing the risk of diabetes and* Correspondence: c3.wu@qut.edu.au1School of Nursing and Midwifery, Institute of Health and BiomedicalInnovation, Queensland University of Technology, Victoria Park Road, KelvinGrove, QLD 4059, AustraliaFull list of author information is available at the end of the articleWu et al. BMC Health Services Research 2011, 11:74http://www.biomedcentral.com/1472-6963/11/74© 2011 Wu et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative CommonsAttribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction inany medium, provided the original work is properly cited.its associated cardiac complications is vitally importantnot only from a personal, but also an economicperspective.Two previous studies undertaken by the first twoauthors provided the basis for developing the initial Car-diac-Diabetes Self-Management Program (CDSMP). Anexploratory study of the demographic characteristicsand incidence of critical cardiac admission for patientswith type 2 diabetes over a four-year period indicated15% of all Coronary Care Unit (CCU) patients had aprevious diagnosis of type 2 diabetes, and 22% of thesepatients were readmitted to hospital within 28 dayscompared to only 6% of CCU patients without diabetes[10]. A second study using a qualitative interpretativeapproach to gain in-depth understanding of the needsand experiences of this at-risk group of patients, foundfour main themes of confidence in self, confidence inhealth professionals, feelings of hopelessness and fatiguewere related to managing their conditions following dis-charge [11]. These findings highlighted the complexityfor patients with these two conditions in undertakingself-management. Both studies were invaluable in thedevelopment of a new self-management program, theCDSMP, which was based on self-efficacy construct [12].The self-efficacy construct is based on the effect of aperson’s belief in their abilities to successfully followthrough with planned actions and accomplish goals.Furthermore, a person with high self-efficacy will tendto set higher personal goals than someone with low self-efficacy, who will have very little faith in his/ her abilityto achieve in the area in question [13].Current literature supports the success of self-manage-ment programs based on improving self-efficacy levels inmodifying lifestyles for different patient groups withchronic diseases such as type 2 diabetes [14,15] and car-diac disease [16]. Patients with type 2 diabetes who areadmitted to CCU following a critical cardiac event aresuddenly confronted with a number of life style rulesand advice in order to deal with their illnesses. Oftenthese rules and recommendations are presented sepa-rately for each disease and not tailored to the needs ofpatients with both diabetes and a cardiac condition.Furthermore, such guidance is given by professionalswho might not have experienced any of the challengesthese patients now face.Having peer support during this initial period is veryvaluable. A recent World Health Organisation (WHO)consultation on peer support programs indicated thesewere promising and presented recommendations fordeveloping and evaluating such programs [17]. A peersupport person is someone who has experienced similarconditions, been successful in managing their conditionsand is able to provide relevant and meaningful informa-tion [18].Although the benefits of peer support for improvingchronic illness self-management, including diabetes, toachieve better health outcomes has been demonstrated[18-22] there is limited evidence that self-managementprograms provided by or incorporating peers haveimproved psychological, or reduced health care utiliza-tion [22,23]. Furthermore, no research has yet beenundertaken to evaluate the effectiveness of peer supportfor patients with both type 2 diabetes and cardiac condi-tions, nor has it been evaluated in different contexts(hospital and community).AimTo develop and pilot test a Cardiac-Diabetes Self-Man-agement Program (CDSMP) utilising peer support forimproving self-management for patients with both dia-betes and cardiac conditions.Objectives• To further develop a CDSMP for patients withtype 2 diabetes following a critical cardiac event,including the development of a DVD incorporatingstories from a range of case studies, and use of for-mer patients (peers) to provide support in adoptingself-management strategies.• To evaluate the feasibility and applicability of theDVD and peer supported CDSMP.Hypotheses• Anticipated outcomes for the intervention groupwhen compared to the control group receiving usualcare will include:• Higher self-management practice scores;• Higher self-efficacy levels;• Higher knowledge scores.Methods/DesignThe pilot study using randomised controlled trial design(parallel-group trial) within the participants’ usual healthcare environment will be conducted in three distinct butoverlapping phases: (1) development of the trainingpackage including the CDSMP materials and DigitalVideo Disk (DVD), (2) peer selection and training, and(3) intervention phase. These will each be describedbelow.Phase 1: Development of the CDSMPThe intervention utilised in this project will be based onthe Cardiac Diabetes Self Management Program devel-oped in earlier research by the first two authors [12]. Itwill be modified according to feedback from its initialtrial, which included suggestions for adding a multimediaWu et al. BMC Health Services Research 2011, 11:74http://www.biomedcentral.com/1472-6963/11/74Page 2 of 7component; this will take the form of a DVD. The DVDwill be provided to participants in the interventiongroup to assist them to apply strategies from the self-efficacy model; it will take the form of narrative “real-life” stories of people managing both diabetes and car-diac conditions. A further addition to the program willbe the use of peers to provide follow-up support toparticipants.The CDSMP program consists of three face-to-facesessions and telephone and text-messaging follow-up.The face-to-face sessions will be provided by a trainedResearch Nurse, and be conducted while the patientsare in CCU and continue as the patient makes the tran-sition home after discharge. The participants will be tel-ephoned 1 week after discharge home and 2 text-messages will be sent a week after telephone follow up.These will be conducted by the trained ‘peers’.Reference GroupA reference group will be formed for the purposes ofinforming and reviewing program materials. The panelwill consist of experts in the field (e.g. cardiologists, dia-betes educators, cardiac rehabilitation coordinators) plusthe researchers. After agreeing to participate, panellistswill attend face-to-face meetings to establish the rolesand responsibilities of the panel, such as reviewing andcommenting on program development, including DVDproduction, and to agree on acceptable methods of com-munication. The panel will provide an important sourceof guidance in the production of all educational materi-als, in particular the DVD.DVD Production“Actors” in the DVD will be actual people dealing withdiabetes and cardiac conditions and discussions will beheld between these actors, the production team andChief Investigator to ensure understanding of individualroles, as well as the DVD as a whole. Prior to produc-tion, reference group members will be given the oppor-tunity to review and comment on the DVD script. Theresulting DVD will be presented to the reference groupfor final approval before its use within the CDSMP.Phase 2: Peer Selection & TrainingSelection and training of peer supporters is a crucialcomponent to this project; a peer supporter is someonewho has similar conditions, and can use their ownexperience to provide information to others. The peersupport person can be very useful to others who are try-ing to work out the best ways of managing their health[18]. Potential peers, who are considered competent inthe management of their conditions will be identified bythe cardiologist and subsequently trained by theresearchers. To facilitate the training process, a detailedpeer training manual will be developed, also utilisingself-efficacy principles.Phase 3: InterventionControl group (group 1): Participants will receive usualcare, which consists of education provided in the CCUand referral as necessary to the diabetes educator.Intervention group (group 2): Participants will receiveusual care and a combination of CDSMP sessions in theCCU, plus peer telephone and text follow-ups.The CDSMP is designed to be administered on a one-to-one basis and to commence in CCU by staff mem-bers, then be followed up by trained peers via a tele-phone call one week after discharge and text messagereminders from peers in weeks three and four. If apatient is transferred to a ward before completing theprogram, the hospital-based section of the CDSMP willbe continued on the ward by the trained research nurse.As part of the program, the DVD based on incorpor-ating stories from a range of case studies is developedand will be provided to participants in the interventiongroup to assist them with the application of strategiesfrom the Self-Efficacy Model.Settings and locationsThe study will be conducted in the Coronary Care Units(CCU) at Mater Health Services, and followed up by tel-ephone and text messages at participants’ homes in Bris-bane, Australia.ParticipantsSample sizeA total of 30 patients for 2 groups will be required. Thissample size of 10-15 per group is suggested by Hertzog(2008) [19]. This number is calculated with an alpha of0.05 and power of 0.9, thus 10 patients per group willbe required to detect any statistical differences. Allowing20% attrition rate, 13 patients per group will berequired. Thus with an alpha of 0.05 and power of 0.9,8 patients per group was required to detect any statisti-cal differences.Inclusion criteriaParticipants who will be included:• are males and females aged over 18 years who havegiven their consent to participate in the study• have had type 2 diabetes for at least one year andhave been admitted to the CCU with a critical car-diac event in the study hospitals• can read and converse in English• are physically stabilised• have a mobile phoneExclusion criteria• Potential participants will be excluded if they:• are unable to read and speak English• are transferred to another hospital.• are on respiratory ventilation• are unconsciousWu et al. BMC Health Services Research 2011, 11:74http://www.biomedcentral.com/1472-6963/11/74Page 3 of 7Minority groups or people from non-English speakingbackgrounds (NESB) will be included unless they cannotread and speak English. English is needed, as the materi-als are in English. Programs for non-English speakingpatients will be developed in future projects.RandomisationSimple randomisation using a randomisation table(computerised sequence generation) will be used. Allo-cation will be concealed by using sealed, numbered, opa-que envelopes to both control and intervention groups.Data CollectionPrimary and secondary outcomes: Primary outcomesinclude self-efficacy, self-care behaviour and knowledge.Secondary outcome is readmission rate within 28 days.Baseline (Time 1): When patients’ physical conditionis stable they will be invited by a Research Assistant(RA) to participate in the study. Following explanationof the study, demographic and baseline data will be col-lected for those giving informed consent.One month follow-up (Time 2): A questionnaire willbe posted to participants at their discharge location,after which the RA will telephone the participant andcollect data over the phone. Posting the questionnairefirst will facilitate data collection in the telephone inter-view. This method has been used previously by aresearch team member [24], resulting in a high responserate (84%).MeasuresData will be collected on primary outcomes of thisstudy: self-management practice, self-efficacy, knowledgeand secondary outcome: readmission rates.Self-management practiceData will be collected at Time 1 and Time 2, and will bemeasured using the Summary of Diabetes Self-CareActivities (SDSCA) [25]. The SDSCA comprises 11items that measure patients’ adherence to self-manage-ment activities such as diet, exercise, blood glucose test-ing, foot care, and smoking status. The respondents willbe asked to rate each item using 0-7 scale, with 7 indi-cating most adherence to each aspect, and 0 for non-compliance. Permission to use this tool has beengranted by the authors.Self-efficacyData will be collected at Time 1 and Time 2, and will bemeasured using the Diabetes Management Self-EfficacyScale (DMSES) (Australian-English version) [26]. TheDMSES comprises 20 items that measure patients’ con-fidence levels (self-efficacy) in managing their diabetes.The respondents will be asked to rate each item using0-10 scale, with 10 indicating the highest confidencelevel, and 0 the lowest. This scale is designed tomeasure the self-efficacy levels of patients with type 2diabetes. A high internal consistency was demonstratedby the Cronbach alpha coefficient of 0.9. Face validitywas established through consultation with diabetes edu-cators and patients with type 2 diabetes, and convergentvalidity was demonstrated by the significant correlationsbetween DMSES and the General Self-Efficacy Scale(GSE). Permission to use this tool has been granted.KnowledgeData will be collected at Time 1 and Time 2, and will bemeasured using Diabetes Knowledge Questions (DKQ)[27]. The DKQ measures patients’ knowledge of diabetesand cardiac conditions. Each item with a correct answerscores one point; score ranges are therefore 0 to 8.Cronbach alpha for DKQ is 0.7, indicating good internalconsistency [27]. In addition, this scale is brief and unli-kely to cause a ‘response burden’; particularly as patientswho have diabetes and have had a cardiac conditionmay become tired answering questions. Permission touse this tool has been granted.Readmission rateReadmission rate will be collected at Time 2, and will beascertained from hospital records.ProcedureThe nominated RA will liaise with the Nurse Unit Man-ager (NUM) of the CCU, to obtain a list of eligible par-ticipants from the CCU Admission Book. The RA willthen approach the potential participants for theirinformed consent and to collect baseline data. Afterbaseline data is collected, a computer-generated list ofrandom numbers produced by the researcher will thenbe used to randomly assign participants to either thecontrol group or the intervention group (See Figure 1:Overview of data collection). Patients are blinded toreceive either usual care or usual care and CDSMP,however the RA who assisting with data analysis is notblinded.Control group (group 1): Participants will receiveusual care, which consists of education provided in theCCU and referral as necessary to the diabetes educator.Intervention group (group 2): Participants will receiveusual care and a combination of CDSMP sessions in theCCU, plus peer telephone and text follow-ups. TheCDSMP was designed to be administered on a one-to-one basis and to commence in CCU by staff members,then be followed up by trained peers via a telephonecall one week after discharge and text message remin-ders from peers in weeks three and four. If a patient istransferred to a ward before completing the program,the hospital-based section of the CDSMP will be contin-ued on the ward by the trained research nurse.As part of the program, the DVD based on incorpor-ating stories from a range of case studies is developedWu et al. BMC Health Services Research 2011, 11:74http://www.biomedcentral.com/1472-6963/11/74Page 4 of 7and will be provided to participants in the interventiongroup to assist them with the application of strategiesfrom the Self-Efficacy Model.Data AnalysisPrior to undertaking statistical tests, the homogeneity ofthe sample will be examined. Due to small samples size;non-parametric statistical tests will be used to determinethe relationships and differences between disease anddemographic variables: Chi-square for categorical vari-ables and Mann-Whitney U test for continuous vari-ables. The Wilcoxon Signed Rank test will be used todetermine whether any changes in outcome variablesoccurred within and between groups over time. Mann-Whitney U test will be used to confirm whether there isan interaction between time and group. All analyses willbe conducted using SPSS version 18 with a pre-definedlevel of statistical significance at p < 0.05.Ethical ConsiderationsEthical approvals have been granted by the MaterHealth Services Human Research Ethics Committee andQueensland University of Technology Human ResearchEthics Committee.Informed consent: All participants will be volunteerswho will provide written consent, and will be free towithdraw at any time. Confidentiality: No identifyinginformation will be kept with the data, which will beanalysed and stored on a secure network drive at theuniversity, protected by password and used only for thepurposes of this study. Only the researchers involved inthis study will have access to the data. While no infor-mation about the project will be published in any formthat will allow any individual to be recognised; non-identifiable results will be reported within the hospitaland in the literature.This study protocol is now registered with the Austra-lia and New Zealand Clinical Trials Registry (TrialNumber: ACTRN12611000086965).DiscussionThis protocol has provided information on planning andpilot testing the feasibility of a peer-support based car-diac-diabetes self-management program. This projectT1: Baseline data collection by Research Assistant (RA) Randomisation by Researcher Control group (n = 15) Intervention group (n = 15) Randomisation Usual and/or Intervention   T2  DATA COLLECTION Hospital - Usual care by hospital staff  Hospital -  Usual care by hospital staff - CDSMP by Research Nurse Telephone/texts by peers T2: Data collection at 4 weeks post discharge by RA  LosT to follow up at 4 weeks Sample (n = 30) Screening, inclusion, exclusion, consent Figure 1 Overview of Data Collection.Wu et al. BMC Health Services Research 2011, 11:74http://www.biomedcentral.com/1472-6963/11/74Page 5 of 7aims to compare and evaluate transitional care interven-tions in order to reduce readmission rates and emer-gency health service visits by patients with diabetes anda cardiac event, and to improve their health, and psy-chosocial well-being. Additionally, this project seeks toimprove the uptake of appropriate self-management inpeople with both diabetes and a cardiac condition, andencourage maintenance of independence. The findingsof this pilot study will provide baseline knowledge forundertaking a larger study to test the effectiveness of aself-management program, which incorporates text mes-saging and telephone follow-up by a peer support per-son for patients with both diabetes and a cardiaccondition.LimitationsThe results of this pilot study will provide valuableinformation of the feasibility and acceptability of thepeer-support based cardiac-diabetes self-managementprogram, and direction of power analysis for requiredsample size for a larger study. However, staff variationsand trend of patients within participating study sitesmay vary for a future full study. For example, patients’self-care behaviour and self-efficacy levels may not beconsistent with pilot study. The research nurse trainedfor this study is specialised in coronary care, whichcould possibly lead to contamination associated withdelivering the program.ConclusionsThe proposed peer-support based self-management pro-gram uses self-efficacy construct of Bandura’s SocialCognitive Theory which is flexible and could potentiallybe adapted in other chronic diseases. This intervention,incorporating peers and telephone and text-messagingapproach will provide important information for futureresearch and care planning.Acknowledgements & FundingThis Peer Support based Cardiac-Diabetes Self-Management Program issupported by funding from the Department of Health & Ageing through the‘Sharing Health Care Initiative’ Research Grant in Australia. The authors alsowould like to express special thanks to the reference group.Author details1School of Nursing and Midwifery, Institute of Health and BiomedicalInnovation, Queensland University of Technology, Victoria Park Road, KelvinGrove, QLD 4059, Australia. 2Mater Health Services, Brisbane, Australia.3Health and Social Development, University of British Columbia Okanagan,Kelowna BC V1V 1V7, Canada. 4Department of Graduate Studies, LienhardSchool of Nursing, Lienhard Hall 309 Pace University, 861 Bedford Road,Pleasantville, New York 10570-2799, USA. 5School of Medicine, University ofQueensland, Australia.Authors’ contributionsCJW, the principal investigator of the study, conducted the data analysiswith oversight of co-authors: AMC, MC, LMSB, and KK, drafted the initialmanuscript. All co-authors reviewed and approved the final draft. KKparticipated in preparation of selecting and training peers, and criticallyreviewed, edited and approved the final draft.Competing interestsThe authors declare that they have no competing interests.Received: 12 December 2010 Accepted: 11 April 2011Published: 11 April 2011References1. Wild S, Roglic G, Green A, Scicree R, King H: Global prevalence of diabetes:Estimates for the year 2000 and projections for 2030. 2004, 27:1045-53.2. World Health Organisation: Country and regional data: Prevalence ofdiabetes worldwide. 2008 [http://www.who.int/diabetes/facts/world_figures/en/print.html], Accessed August 15.3. Australian Institute of Health and Welfare (AIHW): Diabetes: Australia Facts2008. Canberra: Australian Institute of Health & Welfare; 2008.4. Australian Bureau of Statistics (ABS): Diabetes in Australia: A snapshot,2004-05. 2006 [http://www.abs.gov.au/ausstats/abs@.nsf/mf/4820.0.55.001/].5. Diabetes Australia: Diabetes Facts. Canberra: Diabetes Austrlia; 2008.6. 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Foster G, Taylor SJ, Eldridge S, Ramsay J, Griffiths CJ: Self-managementeducation programmes by lay leaders for people with chronicconditions. Cochrane Database of Systematic Reviews 2007, CD005108, ArtNo.19. Hertzog MA: Considerations in determining sample size for pilot studies.Research in Nursing & Health 2008, 31:180-191.20. Earp JA, Eng E, O’Malley MS, Altpeter M, Rauscher G, Mayne L, Mathews HF,Lynch KS, Qaqish B: Increasing Use of Mammography Among Older,Rural African American Women: Results From a Community Trial. Am JPub Health 2002, 92:646-54.21. Heisler M: From research to practice/DSME support. Overview of peersupport models to improve diabetes self-management and clinicaloutcomes. Diabetes Spectrum 2007, 20:214-21.22. Heisler M, Piette JD: “I help you, and you help me": facilitated telephonepeer support among patients with diabetes. The Diabetes Educator 2005,31:869-79.23. Paul GM, Smith SM, Whitford DL, O’Shea E, O’Kelly F, O’Dowd T: Peersupport in type 2 diabetes: a randomised controlled trial in primary carewith parallel economic and qualitative analyses: pilot study andprotocol. 2007, 8:45-.Wu et al. BMC Health Services Research 2011, 11:74http://www.biomedcentral.com/1472-6963/11/74Page 6 of 724. Courtney M, Edwards H, Chang AM, Parker A, Finlayson K, Hamilton K:Fewer emergency readmissions and better quality of life for older adultsat risk of hospital readmission: A randomized controlled trial todetermine the effetivess of a 24-week exercise and telephone follow-upprogram. Journal of the American Geriatrics Society (JAGS) 57:395-402.25. Toobert DJ, Hampson SE, Glasgow RE: The summary of Diabetes Self-CareActivities measure: Results from 7 studies and a revised scale. DiabetesCare 2000, 23:943-50.26. McDowell J, Courtney M, Edwards H, Shortridge-Baggett L: Validation ofthe Australian/English version of the Diabetes Management Self-EfficacyScale. Int J Nurs Prac 2005, 11:177-84.27. Persell SD, Keating NL, Landrum MB, Landon BE, Ayanian JZ, Borbas C,Guadagnoli E: Relationship of diabetes-specific knowledge to self-management activities, ambulatory preventive care, and metabolicoutcomes. Prev Med 2004, 39:746-52.Pre-publication historyThe pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6963/11/74/prepubdoi:10.1186/1472-6963-11-74Cite this article as: Wu et al.: Development and pilot test of a peer-support based Cardiac-Diabetes Self-Management Program: A studyprotocol. BMC Health Services Research 2011 11:74.Submit your next manuscript to BioMed Centraland take full advantage of: • Convenient online submission• Thorough peer review• No space constraints or color figure charges• Immediate publication on acceptance• Inclusion in PubMed, CAS, Scopus and Google Scholar• Research which is freely available for redistributionSubmit your manuscript at www.biomedcentral.com/submitWu et al. 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