From Clinic to Community Study

Peer Support Clinical Trial

— C2C  

Official title:

From Clinic to Community: Using Peer Support as a Transition Model for Improving Long-term Diabetes-related Health Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02804620
• Other study ID #: H14-02419
• Status: Recruiting
• Phase: Phase 0
• First received: January 6, 2016
• Last updated: June 14, 2016
• Start date: October 2014
• Est. completion date: September 2017

Study information

• Verified date: June 2016
• Source: University of British Columbia
• Contact: Rowshanak Afshar, MD
• Phone: 778-316-9282
• Email: rowshanak.afshar[@]vch.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study is a 12-month study. There are two different groups in the study. Both groups will enter the study after the graduation from 8-hour diabetes education course taught at VGH, St. Paul's, or Richmond Hospital. The first group will receive on-going support from their peers who have diabetes and are trained specifically to help other patients with diabetes. The second group will receive the usual care.

Description:

This two-phase study is a randomized controlled trial (RCT) comparing usual care to a 12-month peer-led DSMS intervention designed to improve long-term diabetes-related health outcomes.

In Phase 1, the research team will implement a 30-hour peer leader training (PLT) program recruiting adults with type 2 diabetes and equipping them with the diabetes knowledge, facilitation strategies, and communication skills to deliver a DSMS intervention. In Phase 2, the researchers will conduct the peer support intervention, referred to as the Peer-Led, Empowerment-based Approach to Self-management Efforts in Diabetes (PLEASED). Patients randomized to the PLEASED arm will be paired with a peer leader and receive 12 weekly contacts (face-to-face and telephone support) from their peer leader (PL) in the first 3 months followed by 18 bi-weekly telephone support contacts over the last 9 months.

The goal of the PLEASED intervention is to help patients improve glycemic control and diabetes specific QOL and sustain these health benefits over the long-term. To achieve this goal, PLs will address 3 key functions of peer support that include assisting patients in the daily management of their diabetes, providing social and emotional support, and linking patients to clinical care resources.

Participants' inclusion criteria are: to (1) have type 2 diabetes, (2) be 21 years, (3) speak English or Vietnamese or any languages that their peer leaders speak, (4) be willing to be matched with a peer leader, and (5) have a personal land line telephone or mobile phone.

Peer leaders' inclusion criteria are: (1) have diabetes, (2) be 21 years, (3) speak English, (4) have transportation to attend training, (5) be willing to commit to a 30-hour training program, and (6) have a land line telephone or mobile phone (7) have a self-reported HbA1c of 8% or less.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria for Participants:

• To be eligible for the study, patients have to:

1. have type 2 diabetes,

2. be 21 years,

3. speak English or Vietnamese or any languages that their peer leaders speak,

4. be willing to be matched with a peer leader, and

5. have a personal land line telephone or mobile phone.

Exclusion Criteria for Participants:

• They should not participate in the study if they have physical limitations, serious health conditions or addictions to alcohol or drugs, which would hinder meaningful participation in the study.

Inclusion Criteria for Peer Leaders:

1. have diabetes,

2. be 21 years,

3. speak English,

4. have transportation to attend training,

5. be willing to commit to a 30-hour training program, and

6. have a land line telephone or mobile phone

7. have a self-reported HbA1c of 8% or less..

Exclusion Criteria for Peer Leaders:

• They should not participate in the study if they have physical limitations, serious health conditions or addictions to alcohol or drugs, which would hinder meaningful participation in the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Self-management
• Peer Support

Intervention

Behavioral:
• Peer-led, Empowerment-based Approach to Self-management efforts in Diabetes
The investigators will train patients with type 2 diabetes who are well-controlled and pair them up with participants. Peer leaders will help the participants overcome their problems and teach them how to make changes by 5 step goal setting strategy. The peer leaders never give advice on any medical condition. All the medical questions will be referred to the research team.

Locations

Country	Name	City	State
Canada	Vancouver Coastal Health	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Diabetes Association

Country where clinical trial is conducted

Canada, 

References & Publications (51)

Abbey A, Abramis D, Caplan R. Effects of different sources of social support and social conflict on emotional well-being. Soc Sci Med 1985;6:2:111-129.

Anderson G, Horvath J. The growing burden of chronic disease in America. Public Health Rep. 2004 May-Jun;119(3):263-70. — View Citation

Anderson-Loftin W, Barnett S, Bunn P, Sullivan P, Hussey J, Tavakoli A. Soul food light: culturally competent diabetes education. Diabetes Educ. 2005 Jul-Aug;31(4):555-63. — View Citation

Baksi AK, Al-Mrayat M, Hogan D, Whittingstall E, Wilson P, Wex J. Peer advisers compared with specialist health professionals in delivering a training programme on self-management to people with diabetes: a randomized controlled trial. Diabet Med. 2008 Sep;25(9):1076-82. doi: 10.1111/j.1464-5491.2008.02542.x. — View Citation

Block G, Gillespie C, Rosenbaum EH, Jenson C. A rapid food screener to assess fat and fruit and vegetable intake. Am J Prev Med. 2000 May;18(4):284-8. — View Citation

Cade JE, Kirk SF, Nelson P, Hollins L, Deakin T, Greenwood DC, Harvey EL. Can peer educators influence healthy eating in people with diabetes? Results of a randomized controlled trial. Diabet Med. 2009 Oct;26(10):1048-54. doi: 10.1111/j.1464-5491.2009.02808.x. — View Citation

Canadian Diabetes Association. The prevalence and costs of diabetes. Diabetes.ca (accessed December 1, 2013).

Dale J, Caramlau I, Sturt J, Friede T, Walker R. Telephone peer-delivered intervention for diabetes motivation and support: the telecare exploratory RCT. Patient Educ Couns. 2009 Apr;75(1):91-8. doi: 10.1016/j.pec.2008.09.014. Epub 2008 Nov 14. — View Citation

Dale JR, Williams SM, Bowyer V. What is the effect of peer support on diabetes outcomes in adults? A systematic review. Diabet Med. 2012 Nov;29(11):1361-77. doi: 10.1111/j.1464-5491.2012.03749.x. Review. — View Citation

Deakin T, McShane CE, Cade JE, Williams RD. Group based training for self-management strategies in people with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003417. Review. Update in: Cochrane Database Syst Rev. 2015;6:CD003417. — View Citation

Dennis CL. Peer support within a health care context: a concept analysis. Int J Nurs Stud. 2003 Mar;40(3):321-32. Review. — View Citation

Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. — View Citation

Esliger DW, Tremblay MS. Technical reliability assessment of three accelerometer models in a mechanical setup. Med Sci Sports Exerc. 2006 Dec;38(12):2173-81. — View Citation

Fischman J. Who will take care of you? US News World Rep. 2005 Jan 31-Feb 7;138(4):44-6. — View Citation

Gillespie P, O'Shea E, Paul G, O'Dowd T, Smith SM. Cost effectiveness of peer support for type 2 diabetes. Int J Technol Assess Health Care. 2012 Jan;28(1):3-11. doi: 10.1017/S0266462311000663. — View Citation

Glasgow RE, Boles SM, McKay HG, Feil EG, Barrera M Jr. The D-Net diabetes self-management program: long-term implementation, outcomes, and generalization results. Prev Med. 2003 Apr;36(4):410-9. — View Citation

Haas L, Maryniuk M, Beck J, Cox CE, Duker P, Edwards L, Fisher EB, Hanson L, Kent D, Kolb L, McLaughlin S, Orzeck E, Piette JD, Rhinehart AS, Rothman R, Sklaroff S, Tomky D, Youssef G; 2012 Standards Revision Task Force. National standards for diabetes self-management education and support. Diabetes Care. 2013 Jan;36 Suppl 1:S100-8. doi: 10.2337/dc13-S100. — View Citation

Heisler M, Vijan S, Makki F, Piette JD. Diabetes control with reciprocal peer support versus nurse care management: a randomized trial. Ann Intern Med. 2010 Oct 19;153(8):507-15. doi: 10.7326/0003-4819-153-8-201010190-00007. — View Citation

Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res. 2004 Aug;39(4 Pt 1):1005-26. — View Citation

Institute of Medicine of the National Academies (report). Crossing the quality chasm: A new heart system for the 21st century/Committee on Quality Health Care in America. Washington, DC. National Academy Press, 2001.

Institute of Medicine of the National Academies (report). Unequal treatment: Confronting Racial and ethnic disparities in health care. Washington, DC. National Academic Press, 2002.

Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. Erratum in: Lancet 1999 Aug 14;354(9178):602. — View Citation

Keyserling TC, Samuel-Hodge CD, Ammerman AS, Ainsworth BE, Henríquez-Roldán CF, Elasy TA, Skelly AH, Johnston LF, Bangdiwala SI. A randomized trial of an intervention to improve self-care behaviors of African-American women with type 2 diabetes: impact on physical activity. Diabetes Care. 2002 Sep;25(9):1576-83. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. — View Citation

Kulzer B, Hermanns N, Reinecker H, Haak T. Effects of self-management training in Type 2 diabetes: a randomized, prospective trial. Diabet Med. 2007 Apr;24(4):415-23. Epub 2007 Feb 12. — View Citation

Lewin S, Munabi-Babigumira S, Glenton C, Daniels K, Bosch-Capblanch X, van Wyk BE, Odgaard-Jensen J, Johansen M, Aja GN, Zwarenstein M, Scheel IB. Lay health workers in primary and community health care for maternal and child health and the management of infectious diseases. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD004015. doi: 10.1002/14651858.CD004015.pub3. Review. — View Citation

Lorig K, Ritter PL, Laurent DD, Plant K, Green M, Jernigan VB, Case S. Online diabetes self-management program: a randomized study. Diabetes Care. 2010 Jun;33(6):1275-81. doi: 10.2337/dc09-2153. Epub 2010 Mar 18. — View Citation

Lorig K, Ritter PL, Villa F, Piette JD. Spanish diabetes self-management with and without automated telephone reinforcement: two randomized trials. Diabetes Care. 2008 Mar;31(3):408-14. Epub 2007 Dec 20. — View Citation

Lorig K, Ritter PL, Villa FJ, Armas J. Community-based peer-led diabetes self-management: a randomized trial. Diabetes Educ. 2009 Jul-Aug;35(4):641-51. doi: 10.1177/0145721709335006. Epub 2009 Apr 30. — View Citation

McKay HG, Glasgow RE, Feil EG, Boles SM, Barrera M. Internet-based diabetes self-management and support: Initial outcomes from the Diabetes Network project, Rehabil Psychol 2002;47:31-48.

Murrock CJ, Higgins PA, Killion C. Dance and peer support to improve diabetes outcomes in African American women. Diabetes Educ. 2009 Nov-Dec;35(6):995-1003. doi: 10.1177/0145721709343322. Epub 2009 Sep 23. — View Citation

Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001 Mar;24(3):561-87. Review. — View Citation

Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002 Jul;25(7):1159-71. — View Citation

Norris SL, Nichols PJ, Caspersen CJ, Glasgow RE, Engelgau MM, Jack L, Snyder SR, Carande-Kulis VG, Isham G, Garfield S, Briss P, McCulloch D. Increasing diabetes self-management education in community settings. A systematic review. Am J Prev Med. 2002 May;22(4 Suppl):39-66. Review. — View Citation

Padgett D, Mumford E, Hynes M, Carter R. Meta-analysis of the effects of educational and psychosocial interventions on management of diabetes mellitus. J Clin Epidemiol. 1988;41(10):1007-30. — View Citation

Philis-Tsimikas A, Fortmann A, Lleva-Ocana L, Walker C, Gallo LC. Peer-led diabetes education programs in high-risk Mexican Americans improve glycemic control compared with standard approaches: a Project Dulce promotora randomized trial. Diabetes Care. 2011 Sep;34(9):1926-31. doi: 10.2337/dc10-2081. Epub 2011 Jul 20. — View Citation

Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. — View Citation

Pratt C, Wilson W, Leklem J, Kingsley L. Peer support and nutrition education for older adults with diabetes. J Nutr Elder. 1987 Summer;6(4):31-43. — View Citation

Report of a World Health Organization consultation. Peer support programmes in diabetes November 5-7, 2007.

Reported by Joanne Currie, Executive Director of Canadian Diabetes Educators Certification Board.

Resnicow K, Campbell M, Carr C, McCarty F, Wang T, Periasamy S, Rahotep S, Doyle C, Williams A, Stables G. Body and soul. A dietary intervention conducted through African-American churches. Am J Prev Med. 2004 Aug;27(2):97-105. — View Citation

Sarason I, Sarason B, Brock D, Pierce G. Social support: current status, current issues. Spielberger CE. Stress and Emotion: Anxiety, Anger, and Curiously. Washington DC: Taylor and Francis; 1998

Siminerio L, Ruppert KM, Gabbay RA. Who can provide diabetes self-management support in primary care? Findings from a randomized controlled trial. Diabetes Educ. 2013 Sep-Oct;39(5):705-13. doi: 10.1177/0145721713492570. Epub 2013 Jun 19. — View Citation

Smith SM, Paul G, Kelly A, Whitford DL, O'Shea E, O'Dowd T. Peer support for patients with type 2 diabetes: cluster randomised controlled trial. BMJ. 2011 Feb 15;342:d715. doi: 10.1136/bmj.d715. — View Citation

Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. — View Citation

Tang TS, Funnell M, Sinco B, Piatt G, Palmisano G, Spencer MS, Kieffer EC, Heisler M. Comparative effectiveness of peer leaders and community health workers in diabetes self-management support: results of a randomized controlled trial. Diabetes Care. 2014 Jun;37(6):1525-34. doi: 10.2337/dc13-2161. Epub 2014 Apr 10. — View Citation

Tang TS, Funnell MM, Gillard M, Nwankwo R, Heisler M. The development of a pilot training program for peer leaders in diabetes: process and content. Diabetes Educ. 2011 Jan-Feb;37(1):67-77. doi: 10.1177/0145721710387308. Epub 2011 Jan 10. — View Citation

Tang TS, Funnell MM, Gillard M, Nwankwo R, Heisler M. Training peers to provide ongoing diabetes self-management support (DSMS): results from a pilot study. Patient Educ Couns. 2011 Nov;85(2):160-8. doi: 10.1016/j.pec.2010.12.013. Epub 2011 Feb 2. — View Citation

Tang TS, Sohal PS, Garg AK. Evaluating a diabetes self-management support peer leader training programme for the English- and Punjabi-speaking South-Asian community in Vancouver. Diabet Med. 2013 Jun;30(6):746-52. doi: 10.1111/dme.12179. Epub 2013 Apr 17. — View Citation

Thom DH, Ghorob A, Hessler D, De Vore D, Chen E, Bodenheimer TA. Impact of peer health coaching on glycemic control in low-income patients with diabetes: a randomized controlled trial. Ann Fam Med. 2013 Mar-Apr;11(2):137-44. doi: 10.1370/afm.1443. — View Citation

Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. — View Citation

* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in diabetes-specific QoL		0, 3, 12 month(s)	No
Other	Blood Pressure		0, 3, 12 month(s)	No
Other	Height		0, 3, 12 month(s)	No
Other	Weight		0, 3, 12 month(s)	No
Primary	Change in HbA1c%		0, 3, 12 month(s)	No
Secondary	ApoB		0, 3, 12 month(s)	No