Clinical trial NCT02804620: From Clinic to Community Study
Official title: From Clinic to Community: Using Peer Support as a Transition Model for Improving Long-term Diabetes-related Health Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peer Support
Diabetes Self-management
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Diabetes Association
First posted: 2016-06-17
Enrollment: 196
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in HbA1c%
timeFrame: 0, 3, 12 month(s)
Secondary outcomes:
measure: ApoB
timeFrame: 0, 3, 12 month(s)
Other outcomes:
measure: Change in diabetes-specific QoL
timeFrame: 0, 3, 12 month(s)
measure: Blood Pressure
timeFrame: 0, 3, 12 month(s)
measure: Height
timeFrame: 0, 3, 12 month(s)
measure: Weight
timeFrame: 0, 3, 12 month(s)
Locations:
city: Vancouver
country: Canada
facility: Vancouver Coastal Health
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Tricia S Tang, PhD
role: PRINCIPAL_INVESTIGATOR
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