Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
196 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-10-31
Study Completion Date
2018-09-30
Brief Summary
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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
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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.
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.
Conditions
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Peer Support
Diabetes Self-management
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Peer-led, Empowerment-based Approach to Self-management efforts in Diabetes
Intervention Type
BEHAVIORAL
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.
Wait List
The wait list will receive three free health screening (at baseline, 3months, 12 months) and monetary compensation for their time and effort.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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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.
Intervention Type
BEHAVIORAL
Other Intervention Names
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PLEASED
Eligibility Criteria
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Inclusion Criteria
* 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.
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..
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.
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
* 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.
* 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.
* 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.
Minimum Eligible Age
21 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Canadian Diabetes Association
OTHER
Sponsor Role
collaborator
University of British Columbia
OTHER
Sponsor Role
lead
Responsible Party
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Tricia Tang
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Tricia S Tang, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Vancouver Coastal Health
Vancouver, British Columbia, Canada
Site Status
Countries
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Canada
References
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RESULT
Norris SL, Lau J, Smith SJ, Schmid CH, Engelgau MM. Self-management education for adults with type 2 diabetes: a meta-analysis of the effect on glycemic control. Diabetes Care. 2002 Jul;25(7):1159-71. doi: 10.2337/diacare.25.7.1159.
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RESULT
Norris SL, Engelgau MM, Narayan KM. Effectiveness of self-management training in type 2 diabetes: a systematic review of randomized controlled trials. Diabetes Care. 2001 Mar;24(3):561-87. doi: 10.2337/diacare.24.3.561.
Reference Type
RESULT
Seddigh S, Tang TS. Social support and diabetes distress: Does the messenger matter as much as the message? Chronic Illn. 2023 Sep;19(3):681-685. doi: 10.1177/17423953221102622. Epub 2022 May 26.
Reference Type
DERIVED
Afshar R, Askari AS, Sidhu R, Cox S, Sherifali D, Camp PG, Tang TS. Out of the mouths of Peer Leaders: Perspectives on how to improve a telephone-based peer support intervention in type 2 diabetes. Diabet Med. 2022 Sep;39(9):e14853. doi: 10.1111/dme.14853. Epub 2022 Apr 30.
Reference Type
DERIVED
Other Identifiers
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H14-02419
Identifier Type: -
Identifier Source: org_study_id