From Clinic to Community Study

Study Overview
=================
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.

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

Conditions
-----------------
Peer Support, Diabetes Self-management

Intervention / Treatment
-----------------
* Behavioral: Peer-led, Empowerment-based Approach to Self-management efforts in Diabetes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Participants: To be eligible for the study, patients have to: have type 2 diabetes, be 21 years, speak English or Vietnamese or any languages that their peer leaders speak, be willing to be matched with a peer leader, and 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: have diabetes, be 21 years, speak English, have transportation to attend training, be willing to commit to a 30-hour training program, and have a land line telephone or mobile phone 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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLEASED<br>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<br>* 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.<br>* Other names: PLEASED;|
| No Intervention: Wait List<br>The wait list will receive three free health screening (at baseline, 3months, 12 months) and monetary compensation for their time and effort. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c% |  | 0, 3, 12 month(s) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ApoB |  | 0, 3, 12 month(s) |