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From Clinic to Community Study (C2C)

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ClinicalTrials.gov Identifier: NCT02804620
Recruitment Status : Unknown
Verified June 2016 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Collaborator:
Canadian Diabetes Association
Information provided by (Responsible Party):
University of British Columbia

Brief 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.

Condition or disease Intervention/treatment Phase
Peer Support Diabetes Self-management Behavioral: Peer-led, Empowerment-based Approach to Self-management efforts in Diabetes Early Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: From Clinic to Community: Using Peer Support as a Transition Model for Improving Long-term Diabetes-related Health Outcomes
Study Start Date : October 2014
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Arm Intervention/treatment
Experimental: PLEASED
The PLEASED intervention arm will receive peer leader who is patients with diabetes that has been gone through our trainings. Also, they will receive three free health screenings (baseline, 3 months, 12 months) and monetary compensation for their time and effort.
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.
Other Name: PLEASED

No Intervention: Wait List
The wait list will receive three free health screening (at baseline, 3months, 12 months) and monetary compensation for their time and effort.



Primary Outcome Measures :
  1. Change in HbA1c% [ Time Frame: 0, 3, 12 month(s) ]

Secondary Outcome Measures :
  1. ApoB [ Time Frame: 0, 3, 12 month(s) ]

Other Outcome Measures:
  1. Change in diabetes-specific QoL [ Time Frame: 0, 3, 12 month(s) ]
  2. Blood Pressure [ Time Frame: 0, 3, 12 month(s) ]
  3. Height [ Time Frame: 0, 3, 12 month(s) ]
  4. Weight [ Time Frame: 0, 3, 12 month(s) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804620


Contacts
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Contact: Rowshanak Afshar, MD 778-316-9282 rowshanak.afshar@vch.ca
Contact: Tricia S Tang, PhD 604-875-4111 ext 63449 tricia.tang@vch.ca

Locations
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Canada, British Columbia
Vancouver Coastal Health Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Tricia S. Tang, PhD    604-875-4111 ext 63449    tricia.tang@vch.ca   
Contact: Rowshanak Afshar, MD    778-316-9282    rowshanak.afshar@vch.ca   
Sponsors and Collaborators
University of British Columbia
Canadian Diabetes Association
Investigators
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Principal Investigator: Tricia S Tang, PhD University of British Columbia
Publications of Results:
Other Publications:
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.
Reported by Joanne Currie, Executive Director of Canadian Diabetes Educators Certification Board.
Report of a World Health Organization consultation. Peer support programmes in diabetes November 5-7, 2007.
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.
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
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.

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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02804620    
Other Study ID Numbers: H14-02419
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No