NCT02804620

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

December 5, 2024

Status Verified

December 1, 2024

Enrollment Period

3.9 years

First QC Date

January 6, 2016

Last Update Submit

December 3, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c%

    0, 3, 12 month(s)

Secondary Outcomes (1)

  • ApoB

    0, 3, 12 month(s)

Other Outcomes (4)

  • Change in diabetes-specific QoL

    0, 3, 12 month(s)

  • Blood Pressure

    0, 3, 12 month(s)

  • Height

    0, 3, 12 month(s)

  • +1 more other outcomes

Study Arms (2)

PLEASED

EXPERIMENTAL

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

Wait List

NO INTERVENTION

The wait list will receive three free health screening (at baseline, 3months, 12 months) and monetary compensation for their time and effort.

Interventions

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.

Also known as: PLEASED
PLEASED

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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..
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver Coastal Health

Vancouver, British Columbia, V5Z 1M9, Canada

Location

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Study Officials

  • Tricia S Tang, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 6, 2016

First Posted

June 17, 2016

Study Start

October 1, 2014

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

December 5, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations