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
|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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||228 participants|
|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|
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.
- Change in HbA1c% [ Time Frame: 0, 3, 12 month(s) ]
- ApoB [ Time Frame: 0, 3, 12 month(s) ]
- Change in diabetes-specific QoL [ Time Frame: 0, 3, 12 month(s) ]
- Blood Pressure [ Time Frame: 0, 3, 12 month(s) ]
- Height [ Time Frame: 0, 3, 12 month(s) ]
- Weight [ Time Frame: 0, 3, 12 month(s) ]
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
|Contact: Rowshanak Afshar, MDemail@example.com|
|Contact: Tricia S Tang, PhD||604-875-4111 ext firstname.lastname@example.org|
|Principal Investigator:||Tricia S Tang, PhD||University of British Columbia|