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C2C: From Clinic to Community Study

Sponsor
University of British Columbia (Other)
Overall Status
Unknown status
CT.gov ID
NCT02804620
Collaborator
Canadian Diabetes Association (Other)
228
Enrollment
1
Location
2
Arms
35
Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
Anticipated 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 :
Oct 1, 2014
Anticipated Primary Completion Date :
Sep 1, 2017
Anticipated Study Completion Date :
Sep 1, 2017

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Change in HbA1c% [0, 3, 12 month(s)]

    Secondary Outcome Measures

    1. ApoB [0, 3, 12 month(s)]

    Other Outcome Measures

    1. Change in diabetes-specific QoL [0, 3, 12 month(s)]

    2. Blood Pressure [0, 3, 12 month(s)]

    3. Height [0, 3, 12 month(s)]

    4. Weight [0, 3, 12 month(s)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Vancouver Coastal Health Vancouver British Columbia Canada V5Z 1M9

    Sponsors and Collaborators

    • University of British Columbia
    • Canadian Diabetes Association

    Investigators

    • Principal Investigator: Tricia S Tang, PhD, University of British Columbia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of British Columbia
    ClinicalTrials.gov Identifier:
    NCT02804620
    Other Study ID Numbers:
    • H14-02419
    First Posted:
    Jun 17, 2016
    Last Update Posted:
    Jun 17, 2016
    Last Verified:
    Jun 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jun 17, 2016