Clinical trial NCT02661581: Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes
Official title: Peer-led, Empowerment-based, Approach to Self-management Efforts in Diabetes: A Pragmatic Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Peer Leader Support
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: VGH and UBC Hospital Foundation
First posted: 2016-01-22
Enrollment: 114
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycemic Control measured by HbA1c
timeFrame: Up to 12 months
Secondary outcomes:
measure: Blood pressure (mmHg) measured by Omron BP785 monitor
timeFrame: Up to 12 months
measure: ApoB (g/L) will be collected using venous puncture blood draw
timeFrame: Up to 12 months
measure: Waist circumference (inch) measured by Seca 203 Circumference Measuring Tape
timeFrame: Up to 12 months
measure: Body Mass Index (kg/m2)
timeFrame: Up to 12 months
measure: Physical activity measured by the actical accelerometer
timeFrame: Up to 12 months
measure: 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
timeFrame: Up to 12 months
measure: Depressive Symptom Severity will be assessed with the PRIME-MD Patient Health Questionnaire (PHQ-9)
timeFrame: Up to 12 months
measure: Diabetes-related distress measured by the Diabetes Distress Scale (DDS), a 17-item scale developed by Polonsky and colleagues
timeFrame: Up to 12 months
measure: Height measured using a stadiometer
timeFrame: Up to 12 months
measure: Weight measured on a high quality, calibrated digital scale, with the participant wearing clothes, but no shoes
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Tricia Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References: