Skip to main content
Top
Published in: BMC Primary Care 1/2007

Open Access 01-12-2007 | Study protocol

Peer support in type 2 diabetes: a randomised controlled trial in primary care with parallel economic and qualitative analyses: pilot study and protocol

Authors: Gillian M Paul, Susan M Smith, David L Whitford, Eamon O'Shea, Fergus O'Kelly, Tom O'Dowd

Published in: BMC Primary Care | Issue 1/2007

Login to get access

Abstract

Background

Diabetes is a chronic illness, which requires the individual to assume responsibility for their own care with the aim of maintaining glucose and blood pressure levels as close to normal as possible. Traditionally self-management training for diabetes has been delivered in a didactic manner. In recent times alternatives to the traditional delivery of diabetes care have been investigated, for example, the concept of peer support which emphasises patient rather than professional domination. This paper describes the pilot study and protocol for a study that aims to evaluate the effectiveness of a peer support intervention for people with type 2 diabetes in a primary care setting.

Methods/Design

A pilot study was conducted to access the feasibility of a randomized controlled trial of a peer support intervention. We used the MRC Framework for the evaluation of complex interventions. Elements of the intervention were defined and the study protocol was finalized. In this cluster randomised controlled trial twenty general practices are assigned to control and intervention groups. Each practice compiles a diabetes register and randomly selects 21 patients. All practices implement a standardised diabetes care system. In the intervention group all practices recruit three peer supporters. The peer supporters are trained to conduct nine group meetings in their general practice over a period of two years. Each meeting has a structured component. The primary outcomes are blood pressure, total cholesterol, HBA1c and the Diabetes Well-being score. In addition to biophysical, psychosocial, economic and health service utilization data peer supporter activity and qualitative data are collected.

Discussion

Peer support is a complex intervention and evaluating such an intervention presents challenges to researchers. This study will evaluate whether a peer support programme for patients with type 2 diabetes improves biophysical and psychosocial outcomes and whether it is an acceptable, cost effective intervention in the primary care setting.

Trial registration

Current Controlled Trials ISRCTN42541690
Appendix
Available only for authorised users
Literature
1.
go back to reference UKPDS: Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. British Medical Journal. 1998, 317 (7160): 703-713.CrossRef UKPDS: Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. British Medical Journal. 1998, 317 (7160): 703-713.CrossRef
2.
go back to reference Gaede P, Vedel P, Larsen N, Jensen GVH, Parving H-H, Pedersen O: Multifactorial Intervention and Cardiovascular Disease in Patients with Type 2 Diabetes. N Engl J Med. 2003, 348 (5): 383-393. 10.1056/NEJMoa021778.CrossRefPubMed Gaede P, Vedel P, Larsen N, Jensen GVH, Parving H-H, Pedersen O: Multifactorial Intervention and Cardiovascular Disease in Patients with Type 2 Diabetes. N Engl J Med. 2003, 348 (5): 383-393. 10.1056/NEJMoa021778.CrossRefPubMed
3.
go back to reference Griffin S, Kinmonth AL: Systems for routine surveillance for people with diabetes mellitus. The Cochrane Database of Systematic Reviews. 1998, Art. No.: CD000541. DOI: 10.1002/14651858.CD000541, 1CrossRef Griffin S, Kinmonth AL: Systems for routine surveillance for people with diabetes mellitus. The Cochrane Database of Systematic Reviews. 1998, Art. No.: CD000541. DOI: 10.1002/14651858.CD000541, 1CrossRef
4.
go back to reference Renders CM, Valk GD, Griffin S, Wagner EH, van Eijk, Assendelft WJJ: Interventions to improve the management of diabetes mellitus in primary care, output and community settings (Review). The Cochrane Database of Systematic Reviews. 2005, CD001481. doi:10.1002/14651858.CD001481, 4 Renders CM, Valk GD, Griffin S, Wagner EH, van Eijk, Assendelft WJJ: Interventions to improve the management of diabetes mellitus in primary care, output and community settings (Review). The Cochrane Database of Systematic Reviews. 2005, CD001481. doi:10.1002/14651858.CD001481, 4
5.
go back to reference Sturt J, Whitlock S, Hearnshaw H: Complex intervention development for diabetes self-management. Journal of Advanced Nursing. 2006, 54 (3): 293-303. 10.1111/j.1365-2648.2006.03819.x.CrossRefPubMed Sturt J, Whitlock S, Hearnshaw H: Complex intervention development for diabetes self-management. Journal of Advanced Nursing. 2006, 54 (3): 293-303. 10.1111/j.1365-2648.2006.03819.x.CrossRefPubMed
6.
go back to reference Ismail K, Winkley K, Rabe-Hesketh S: Systematic review and meta-analysis of randomised controlled trials of psychological interventions to improve glycaemic control in patients with type 2 diabetes. The Lancet. 2004, 363 (9421): 1589-10.1016/S0140-6736(04)16202-8.CrossRef Ismail K, Winkley K, Rabe-Hesketh S: Systematic review and meta-analysis of randomised controlled trials of psychological interventions to improve glycaemic control in patients with type 2 diabetes. The Lancet. 2004, 363 (9421): 1589-10.1016/S0140-6736(04)16202-8.CrossRef
7.
go back to reference Pill R, Stott NC, Rollnick SR, Rees M: A randomized controlled trial of an intervention designed to improve the care given in general practice to Type II diabetic patients: patient outcomes and professional ability to change behaviour. Fam Pract. 1998, 15 (3): 229-35. 10.1093/fampra/15.3.229.CrossRefPubMed Pill R, Stott NC, Rollnick SR, Rees M: A randomized controlled trial of an intervention designed to improve the care given in general practice to Type II diabetic patients: patient outcomes and professional ability to change behaviour. Fam Pract. 1998, 15 (3): 229-35. 10.1093/fampra/15.3.229.CrossRefPubMed
8.
go back to reference Kinmonth AL, Woodcock A, Griffin S, Spiegal N, Campbell J: Randomised controlled trial of patient centred care of diabetes in general practice: impact on current wellbeing and future risk. British Medical Journal. 1998, 317: 1202-1208.CrossRefPubMedPubMedCentral Kinmonth AL, Woodcock A, Griffin S, Spiegal N, Campbell J: Randomised controlled trial of patient centred care of diabetes in general practice: impact on current wellbeing and future risk. British Medical Journal. 1998, 317: 1202-1208.CrossRefPubMedPubMedCentral
9.
go back to reference de Fine Olivarius N, Beck-Nilsen H, Helms Andreasen A, Horder M, Pedersen P: Randomised controlled trial of structured personal care of type 2 diabetes mellitus. British Medical Journal. 2001, 323: 970-10.1136/bmj.323.7319.970.CrossRef de Fine Olivarius N, Beck-Nilsen H, Helms Andreasen A, Horder M, Pedersen P: Randomised controlled trial of structured personal care of type 2 diabetes mellitus. British Medical Journal. 2001, 323: 970-10.1136/bmj.323.7319.970.CrossRef
10.
go back to reference Smith SM, Bury G, O'Leary M, Shannon W, Tynan A, Staines A, et al: The North Dublin randomized controlled trial of structured diabetes shared care. Family Practice. 2004, 21 (1): 39-45. 10.1093/fampra/cmh109.CrossRefPubMed Smith SM, Bury G, O'Leary M, Shannon W, Tynan A, Staines A, et al: The North Dublin randomized controlled trial of structured diabetes shared care. Family Practice. 2004, 21 (1): 39-45. 10.1093/fampra/cmh109.CrossRefPubMed
12.
go back to reference American Diabetes A: Standards of Medical Care in Diabetes. Diabetes Care. 2005, 28 (suppl_1): S4-36. 10.2337/diacare.28.suppl_1.S4.CrossRef American Diabetes A: Standards of Medical Care in Diabetes. Diabetes Care. 2005, 28 (suppl_1): S4-36. 10.2337/diacare.28.suppl_1.S4.CrossRef
13.
go back to reference Dennis CL: Peer support within a health care context: a concept analysis. International Journal of Nursing Studies. 2003, 40: 321-332. 10.1016/S0020-7489(02)00092-5.CrossRefPubMed Dennis CL: Peer support within a health care context: a concept analysis. International Journal of Nursing Studies. 2003, 40: 321-332. 10.1016/S0020-7489(02)00092-5.CrossRefPubMed
14.
go back to reference Cohen S, Gottlieb B, Underwood L: Social Relationships and Health. Social Support Measurement and Intervention. Edited by: Cohen S, Gottlieb B, L U. 2000, Oxford: Oxford University Press, 3-28.CrossRef Cohen S, Gottlieb B, Underwood L: Social Relationships and Health. Social Support Measurement and Intervention. Edited by: Cohen S, Gottlieb B, L U. 2000, Oxford: Oxford University Press, 3-28.CrossRef
15.
go back to reference Helgeson V, Cohen S: Social Support and Adjustment to Cancer: Reconciling Descriptive, Correlational, and Intervention Research. Health Psychology. 1996, 15 (2): 135-148. 10.1037/0278-6133.15.2.135.CrossRefPubMed Helgeson V, Cohen S: Social Support and Adjustment to Cancer: Reconciling Descriptive, Correlational, and Intervention Research. Health Psychology. 1996, 15 (2): 135-148. 10.1037/0278-6133.15.2.135.CrossRefPubMed
16.
go back to reference Hiscock J, Legard R, Snape D: Listening to diabetes service users: Qualitative findings for the Diabetes National Service Framework. 2001, Department of Health Hiscock J, Legard R, Snape D: Listening to diabetes service users: Qualitative findings for the Diabetes National Service Framework. 2001, Department of Health
17.
go back to reference Smith SM, O'Leary M, Bury G, Stains A, Shannon W: Dublin Diabetes Shared Care (DiSC) Project: A qualitative Investigation of the Views and Health Beliefs of Patients with Type 2 Diabetes. Diabetes Medicine. 2003, 20: 853-857. 10.1046/j.1464-5491.2003.01071.x.CrossRef Smith SM, O'Leary M, Bury G, Stains A, Shannon W: Dublin Diabetes Shared Care (DiSC) Project: A qualitative Investigation of the Views and Health Beliefs of Patients with Type 2 Diabetes. Diabetes Medicine. 2003, 20: 853-857. 10.1046/j.1464-5491.2003.01071.x.CrossRef
18.
go back to reference Lewin SA, Dick J, Pond P, Zwarenstein M, Aja G, Van Wyk B, et al: Lay health workers in primary and community health care. The Cochrane Database of Systematic Reviews. 2003, 4: CD004015.pub2.DOI:10.1002/14651858.CD004015.pub2 Lewin SA, Dick J, Pond P, Zwarenstein M, Aja G, Van Wyk B, et al: Lay health workers in primary and community health care. The Cochrane Database of Systematic Reviews. 2003, 4: CD004015.pub2.DOI:10.1002/14651858.CD004015.pub2
19.
go back to reference Fitzpatrick P, Molloy B, Johnson Z: Community Mothers' programme: extension to the travelling community in Ireland. Journal of Epidemiology and Community Health. 1997, 51: 229-303.CrossRef Fitzpatrick P, Molloy B, Johnson Z: Community Mothers' programme: extension to the travelling community in Ireland. Journal of Epidemiology and Community Health. 1997, 51: 229-303.CrossRef
20.
go back to reference Parent N, Fortin F: A randomized controlled trial of the vicarious experience through peer support for male first time cardiac surgery patients: impact on anxiety, self-efficacy expectations and self reported activity. Heart Lung. 2000, 29 (6): 389-400. 10.1067/mhl.2000.110626.CrossRefPubMed Parent N, Fortin F: A randomized controlled trial of the vicarious experience through peer support for male first time cardiac surgery patients: impact on anxiety, self-efficacy expectations and self reported activity. Heart Lung. 2000, 29 (6): 389-400. 10.1067/mhl.2000.110626.CrossRefPubMed
21.
go back to reference Manandhar DS, Osrin D, Shrestha BP, Mesko N, Tumbahanghe KM, Tamang S, et al: Effect of a participatory intervention with women's groups on birth outcomes in Nepal: cluster-randomised controlled trial. The Lancet. 2004, 364: 970-978. 10.1016/S0140-6736(04)17021-9.CrossRef Manandhar DS, Osrin D, Shrestha BP, Mesko N, Tumbahanghe KM, Tamang S, et al: Effect of a participatory intervention with women's groups on birth outcomes in Nepal: cluster-randomised controlled trial. The Lancet. 2004, 364: 970-978. 10.1016/S0140-6736(04)17021-9.CrossRef
22.
go back to reference Morrow AL, Dawodu A: Influencing birth outcomes in Nepal. The Lancet. 2004, 364 (9438): 914-915. 10.1016/S0140-6736(04)17036-0.CrossRef Morrow AL, Dawodu A: Influencing birth outcomes in Nepal. The Lancet. 2004, 364 (9438): 914-915. 10.1016/S0140-6736(04)17036-0.CrossRef
23.
go back to reference Lorig K, Gonzalez VM: Community-Based Diabetes Self-Management Education: Definition and Case Study. Diabetes Spectrum. 2000, 13 (4): 234-238. Lorig K, Gonzalez VM: Community-Based Diabetes Self-Management Education: Definition and Case Study. Diabetes Spectrum. 2000, 13 (4): 234-238.
24.
go back to reference Medical Research Council: A framework for development and evaluation of RCT's for complex interventions to improve health. 2000, London: Medical Research Council Medical Research Council: A framework for development and evaluation of RCT's for complex interventions to improve health. 2000, London: Medical Research Council
25.
go back to reference Byrne M, Cupples M, Smith SM, Leatham C, Corrigan M, Byrne MC, et al: Development of a Complex Intervention Secondary Prevention of Coronary Heart Disease in Primary Care Using the UK Medical Research Council Framework. The American Journal of Managed Care. 2006, 12: 261-266.PubMed Byrne M, Cupples M, Smith SM, Leatham C, Corrigan M, Byrne MC, et al: Development of a Complex Intervention Secondary Prevention of Coronary Heart Disease in Primary Care Using the UK Medical Research Council Framework. The American Journal of Managed Care. 2006, 12: 261-266.PubMed
26.
go back to reference Petticrew M, Roberts H: Evidence, hierarchies, and typologies: horses for courses. J Epidemiol Community Health. 2003, 57 (7): 527-529. 10.1136/jech.57.7.527.CrossRefPubMedPubMedCentral Petticrew M, Roberts H: Evidence, hierarchies, and typologies: horses for courses. J Epidemiol Community Health. 2003, 57 (7): 527-529. 10.1136/jech.57.7.527.CrossRefPubMedPubMedCentral
27.
go back to reference Bellg A, Resnick B, Minicucci D, Ogedegbe G, Ernst D, Borrelli B, et al: Enhancing treatment fidelity in health behaviour change studies: best practices and recommendations from the NIH behaviour change consortium. Health Psychology. 2004, 5 (443–451): Bellg A, Resnick B, Minicucci D, Ogedegbe G, Ernst D, Borrelli B, et al: Enhancing treatment fidelity in health behaviour change studies: best practices and recommendations from the NIH behaviour change consortium. Health Psychology. 2004, 5 (443–451):
28.
go back to reference Strange V, Forrest S, Oakley A, RIPPLE Study Team: A listening trial: 'qualitative' methods within experimental research. Using Research for Effective Health Promotion. Edited by: Oliver S, Peersman G. 2001, Philadelphia: Open University Press Strange V, Forrest S, Oakley A, RIPPLE Study Team: A listening trial: 'qualitative' methods within experimental research. Using Research for Effective Health Promotion. Edited by: Oliver S, Peersman G. 2001, Philadelphia: Open University Press
30.
go back to reference Clinical Practice Recommendations. Diabetes Care. 1999, 22: S1-10.2337/diacare.22.1.1. Clinical Practice Recommendations. Diabetes Care. 1999, 22: S1-10.2337/diacare.22.1.1.
31.
go back to reference Docherty A, Dale J: The role of the lay health advisor in enhacing psychosocial well being and self management in diabetesL a feasibility study. Annual Scientific Meeting of the Society for Academic Primary Care. 2004 Docherty A, Dale J: The role of the lay health advisor in enhacing psychosocial well being and self management in diabetesL a feasibility study. Annual Scientific Meeting of the Society for Academic Primary Care. 2004
32.
go back to reference Meakin J: With a little help from my peers. Diabetes Update 2003(Autumn 2003). 2003, 18-21. (Autumn 2003) Meakin J: With a little help from my peers. Diabetes Update 2003(Autumn 2003). 2003, 18-21. (Autumn 2003)
33.
go back to reference Health Service Executive. National Shared Services Primary Care Reimbursements: Statistical Analysis of Claims and Payments. Edited by: . 2005, Dublin: HSE Health Service Executive. National Shared Services Primary Care Reimbursements: Statistical Analysis of Claims and Payments. Edited by: . 2005, Dublin: HSE
35.
go back to reference Smith SM: Randomised Controlled Trials in Irish General Practice. Irish Medical Journal. 2004, 97 (7): 215-216.PubMed Smith SM: Randomised Controlled Trials in Irish General Practice. Irish Medical Journal. 2004, 97 (7): 215-216.PubMed
36.
go back to reference Diabetes Action Now An initiative of the World Health Organisation and the International Diabetes Federation. 2004, Geneva: World Health Organisation Diabetes Action Now An initiative of the World Health Organisation and the International Diabetes Federation. 2004, Geneva: World Health Organisation
37.
go back to reference Anderson RM, Lynne SR: How do we know? Reflections on qualitative research in diabetes. Diabetes Care. 1998, 21 (9): 1387-1388. 10.2337/diacare.21.9.1387.CrossRefPubMed Anderson RM, Lynne SR: How do we know? Reflections on qualitative research in diabetes. Diabetes Care. 1998, 21 (9): 1387-1388. 10.2337/diacare.21.9.1387.CrossRefPubMed
38.
go back to reference O'Sullivan T, Harkins V, Houlihan J: Guidelines for Diabetes Care in the Community. 2000, Dublin: Irish College of General Practitioners O'Sullivan T, Harkins V, Houlihan J: Guidelines for Diabetes Care in the Community. 2000, Dublin: Irish College of General Practitioners
39.
go back to reference Bradley C: Handbook of Psychology and Diabetes: A guide to psychological measurement in diabetes research and practice. 1994, Amsterdam: Harwood Academic, first Bradley C: Handbook of Psychology and Diabetes: A guide to psychological measurement in diabetes research and practice. 1994, Amsterdam: Harwood Academic, first
40.
go back to reference Toobert D, Hampson S, Glasgow R: The Summary of Diabetes Self-Care Activities Measure. Diabetes Care. 2000, 23 (7): 943-950. 10.2337/diacare.23.7.943.CrossRefPubMed Toobert D, Hampson S, Glasgow R: The Summary of Diabetes Self-Care Activities Measure. Diabetes Care. 2000, 23 (7): 943-950. 10.2337/diacare.23.7.943.CrossRefPubMed
41.
go back to reference McDowell J, Courtney M, Edwards H, Shortridge-Baggett L: Validation of the Australian/English version of the Diabetes Management Self-Efficacy Scale. Int J Nurs Pract. 2005, 11 (4): 177-184. 10.1111/j.1440-172X.2005.00518.x.CrossRefPubMed McDowell J, Courtney M, Edwards H, Shortridge-Baggett L: Validation of the Australian/English version of the Diabetes Management Self-Efficacy Scale. Int J Nurs Pract. 2005, 11 (4): 177-184. 10.1111/j.1440-172X.2005.00518.x.CrossRefPubMed
42.
go back to reference Horne R: Non-adherence to medication: causes and implications for care. A Behavioural Approach to Pharmacy Practice. Edited by: Gard P. 2001, Oxford: Blackwell, 111-130. Horne R: Non-adherence to medication: causes and implications for care. A Behavioural Approach to Pharmacy Practice. Edited by: Gard P. 2001, Oxford: Blackwell, 111-130.
43.
go back to reference Glasgow R, Toobert D, Barreera M, Strycker L: The Chronic Illness Resources Survey: cross validation and sensitivity to intervention. Health Education Research. 2005, 20 (4): 402-409. 10.1093/her/cyg140.CrossRefPubMed Glasgow R, Toobert D, Barreera M, Strycker L: The Chronic Illness Resources Survey: cross validation and sensitivity to intervention. Health Education Research. 2005, 20 (4): 402-409. 10.1093/her/cyg140.CrossRefPubMed
44.
go back to reference Intercooled Stata 9 [program]. 2006, Texas: StataCorp LP Intercooled Stata 9 [program]. 2006, Texas: StataCorp LP
45.
go back to reference File Maker Pro7 [program]. 2004, Santa Clara: File Maker, Inc File Maker Pro7 [program]. 2004, Santa Clara: File Maker, Inc
46.
go back to reference Borrelli B, Sepinwall D, Bellg A, Breger R, DeFrancesco C, Sharp D, et al: A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behaviour research. Journal of Consulting and Clinical Pyschology. 2005, 73 (5): 852-860. 10.1037/0022-006X.73.5.852.CrossRef Borrelli B, Sepinwall D, Bellg A, Breger R, DeFrancesco C, Sharp D, et al: A new tool to assess treatment fidelity and evaluation of treatment fidelity across 10 years of health behaviour research. Journal of Consulting and Clinical Pyschology. 2005, 73 (5): 852-860. 10.1037/0022-006X.73.5.852.CrossRef
47.
go back to reference Miller WL, Crabtree BJ: A multimethod typology and qualitative roadmap. Doing Qualitative Research. Edited by: Crabtree B, Miller WL. 1999, London: Sage Publications Miller WL, Crabtree BJ: A multimethod typology and qualitative roadmap. Doing Qualitative Research. Edited by: Crabtree B, Miller WL. 1999, London: Sage Publications
48.
go back to reference Todres L: Clarifying the life-world: descriptive phenomenology. Qualitative Research in Healthcare. Edited by: Holloway I. 2005, Maidenhead: Open University Press Todres L: Clarifying the life-world: descriptive phenomenology. Qualitative Research in Healthcare. Edited by: Holloway I. 2005, Maidenhead: Open University Press
49.
go back to reference Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart GL: Methods for the economic evaluation of health care programmes. 2005, Oxford: Oxford University Press Drummond MF, Sculpher MJ, Torrance GW, O'Brien BJ, Stoddart GL: Methods for the economic evaluation of health care programmes. 2005, Oxford: Oxford University Press
50.
go back to reference Johnston K, Gray A, Moher M, Yudkin P, Wright L, Mant D: Reporting the cost-effectiveness of interventions with non-significant effect differences: example from a trial of secondary prevention of coronary heart disease. International Journal of Technology Assessment in Health Care. 2003, 19 (3): 476-489. 10.1017/S0266462303000412.CrossRefPubMed Johnston K, Gray A, Moher M, Yudkin P, Wright L, Mant D: Reporting the cost-effectiveness of interventions with non-significant effect differences: example from a trial of secondary prevention of coronary heart disease. International Journal of Technology Assessment in Health Care. 2003, 19 (3): 476-489. 10.1017/S0266462303000412.CrossRefPubMed
51.
go back to reference Norris S, Engelgau M, Venkat Narayan K: Effectiveness of Self Management Training in Type 2 Diabetes. Diabetes Care. 2001, 24 (3): 561-587. 10.2337/diacare.24.3.561.CrossRefPubMed Norris S, Engelgau M, Venkat Narayan K: Effectiveness of Self Management Training in Type 2 Diabetes. Diabetes Care. 2001, 24 (3): 561-587. 10.2337/diacare.24.3.561.CrossRefPubMed
Metadata
Title
Peer support in type 2 diabetes: a randomised controlled trial in primary care with parallel economic and qualitative analyses: pilot study and protocol
Authors
Gillian M Paul
Susan M Smith
David L Whitford
Eamon O'Shea
Fergus O'Kelly
Tom O'Dowd
Publication date
01-12-2007
Publisher
BioMed Central
Published in
BMC Primary Care / Issue 1/2007
Electronic ISSN: 2731-4553
DOI
https://doi.org/10.1186/1471-2296-8-45

Other articles of this Issue 1/2007

BMC Primary Care 1/2007 Go to the issue