Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes

Diabetes Clinical Trial

— PLEASED  

Official title:

Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes: A Randomized Controlled Trial (The PLEASED Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02661581
• Other study ID #: H13-02163-A002
• Status: Active, not recruiting
• Phase: N/A
• First received: February 24, 2015
• Last updated: November 1, 2016
• Start date: November 2013
• Est. completion date: September 2017

Study information

• Verified date: November 2016
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

PLEASED is a 12-month program that aims to help South Asians with type 2 diabetes improve and sustain diabetes-related health outcomes e.g. glycemic control, quality of life...) achieved from previous short-term diabetes education program. Our goal is to provide a new generation of education and support that can be ongoing, patient-driven, and flexible to the dynamic and evolving conditions of patients' "real-word" environment and life circumstances.

Description:

Diabetes self-management education: In the first three months of PLEASED, patients with type 2 diabetes will participate in 12 weekly sessions: 6 sessions will focus on diabetes education and be delivered by a health professional and 6 sessions will focus on lifestyle change and be delivered by a peer leader. Education sessions will be 2-hours long and be facilitated by nurses, dieticians, and pharmacists. Patients will learn about the diabetes disease process, lifestyle modification, healthy eating, physical activity, medications, monitoring, short- and long- complications, diabetes distress, and coping. Lifestyle change sessions will be 1-hour long and start with 30 minutes of physical activity followed by 30 minutes of goal-setting, action planning, and problem solving. Additional activities such as recipe makeovers and exchanges will also be included.

Diabetes self-management support: In the next nine months of the PLEASED program, patients will be invited to attend 32 weekly self-management support sessions (1-hour long) facilitated by a peer leader. The goal of these sessions is to help patients continue making positive lifestyle changes. Each support session will start with 30 minutes of physical activity led by the peer leader followed by a discussion where participants are invited to (1) discuss self-management challenges, (2) share thoughts and feelings about these challenges, (3) ask self-management questions, (4) engage in problem solving, and (5) set self-management goals and design behavioral experiments to achieve those goals. Patients are invited to attend as frequently as they need or as they are able to given other competing life demands. While these sessions focus on lifestyle change and emotional support, participants will be able to obtain responses to medical and clinical questions from 811 or the PLEASED hotline (hosted by dieticians, nurses, and pharmacists).

All patients enrolled in the PLEASED program will undergo three free health assessments: at the start of the program, at 3 months, and at 12 months. Health assessments will include measuring glycemic control, ApoB, blood pressure, waist circumference, weight, and body mass index. All patients will also complete a survey assessing quality of life, social support, depression, and self-efficacy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

To be eligible to participate as a subject in this study, individuals must

1. Have type 2 diabetes,

2. Be of South Asian background,

3. Live in the Metro Vancouver area,

4. Be at least 21 years old,

5. Have transportation to attend group sessions.

To be eligible to participate as a peer leader in this study, individuals must

1. Have diabetes or are a caregiver to someone who has diabetes,

2. Are of South Asian background,

3. Live in the Greater Vancouver area,

4. Are at least 21 years old,

5. Are bilingual in English and Punjabi,

6. Have transportation to attend training,

7. Are able and willing to commit to 6 sessions of training (5 hours each, over a 6 week period)

Exclusion criteria for both participants and peer leaders include:

1. Serious health conditions

2. Addictions to alcohol or drugs, which would hinder meaningful participation in the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Behavioral:
• Peer Support
The intervention is lifestyle change. First, the peer leaders will be trained how to conduct diabetes self-management education and support sessions. During the first 3 months, all the participants will attend the diabetes self-management education sessions. The participants in the intervention arm will also receive diabetes self-management support sessions as well. In the end of the first 3 months, the intervention group participants will receive weekly support sessions for 9 months.

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	VGH and UBC Hospital Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control measured by HbA1c	To compare a peer support model for diabetes self-management support (DSMS) to usual care on sustaining improvements in glycemic control achieved from short-term diabetes self-management education (DSME).	Up to 12 months	No
Secondary	Blood pressure (mmHg) measured by Omron BP785 monitor		Up to 12 months	No
Secondary	ApoB (g/L) will be collected using venous puncture blood draw		Up to 12 months	No
Secondary	Waist circumference (inch) measured by Seca 203 Circumference Measuring Tape		Up to 12 months	No
Secondary	Body Mass Index (kg/m2)		Up to 12 months	No
Secondary	Physical activity measured by the actical accelerometer		Up to 12 months	No
Secondary	Diabetes-specific Social Support will be assessed using a 4-item perceived social support scale developed by Tang et al. that measures amount of support and satisfaction with support from family, friends and the health care team		Up to 12 months	No
Secondary	Depressive Symptom Severity will be assessed with the PRIME-MD Patient Health Questionnaire (PHQ-9)		Up to 12 months	No
Secondary	Diabetes-related distress measured by the Diabetes Distress Scale (DDS), a 17-item scale developed by Polonsky and colleagues		Up to 12 months	No
Secondary	Height measured using a stadiometer		Up to 12 months	No
Secondary	Weight measured on a high quality, calibrated digital scale, with the participant wearing clothes, but no shoes		Up to 12 months	No