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Completed

NCT Number: NCT02804620

From Clinic to Community Study

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vancouver Coastal Health

Vancouver, British Columbia, V5Z 1M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Other names: PLEASED

Primary outcomes

  1. Change in HbA1c%

    Time frame: 0, 3, 12 month(s)

Secondary outcomes

  1. ApoB

    Time frame: 0, 3, 12 month(s)

Other outcomes

  1. Change in diabetes-specific QoL

    Time frame: 0, 3, 12 month(s)

  2. Blood Pressure

    Time frame: 0, 3, 12 month(s)

  3. Height

    Time frame: 0, 3, 12 month(s)

  4. Weight

    Time frame: 0, 3, 12 month(s)

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Diabetes Association

Registry information

Official study title

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

Acronym: C2C

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 17, 2016
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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