PEARL Program: Empowerment Program for Patients With Type 2 Diabetes (HK4)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Asia Diabetes Foundation
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00950716
First received: July 31, 2009
Last updated: January 6, 2011
Last verified: January 2011
  Purpose

Quality diabetes care requires informed-decisions of motivated care providers and diabetes patients. The investigators aim to use peer support and information technology to facilitate care providers to implement structured care and empower diabetes patients acquire self-management skills in a multi-component program.

The investigators will make use of the following tools: (1) The Joint Asia Diabetes Evaluation (JADE) Program. JADE Program uses a web-based electronic portal to establish a registry and stratify diabetes patients to care protocols based on their risk profiles with features of decision support and data management. (2) The Australasian Telephone Linked Care (TLC) system. TLC system utilizes an automatic, interactive, computer-controlled telephone system to monitor and promote diabetes self-management.

Amongst 600 diabetes patients receiving structured care in Hong Kong through the JADE Program, half of them will be randomized to receive peer support (n=300) including personal coaching by 30 trained mentors (1 mentor to 10 diabetes patients or mentees) through regular phone calls and sharing sessions, and the other half (n=300) will continue the usual diabetes care in their clinic. The 30 mentors are themselves diabetes patients who have good self care and are motivated to support their peers. The mentors will be trained to deliver peer support intervention under supervision by a program manager. The 300 diabetes patients (mentees) randomized to the peer support group are the intervention targets of these 30 mentors. They will be reminded to use the TLC for knowledge enhancement and motivational support.

The investigators will analyse the changes in risk factor control (blood glucose parameters, blood pressure, body weight, lipids), quality of life and cognitive-psychological-behavioral parameters after 12 months. Effects of various components of peer support on these outcomes as well as user acceptability and cost-effectiveness of these programs will be examined.

The investigators will test the hypothesis that in a multi-component program, the use of a peer support program delivered by diabetes patient-mentors, to influence and motivate other diabetes patients receiving structured care made possible through a web-based disease management program, delivered by a doctor-nurse team, will further improve metabolic control, QOL and self care compared to diabetes patients receiving the same standard of care.


Condition Intervention
Diabetes
Behavioral: Patient Peer Support and Empowerment
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Peer Support, Empowerment and Remote Communication Linked by Information Technology (PEARL): A Multi-Component Program to Improve Community-Based Diabetes Care

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Glycemic control and Metabolic changes (body weight, blood pressure and lipid levels) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cognitive-psychological-behavioral assessments: a) Depression Anxiety and Stress Scale (DASS21). b) Diabetes Empowerment Scale (C-DES). c) Summary of Diabetes Self Care Activities (SDSCA, Chinese version). [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: January 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care
The 'control arm' will receive standard usual care with clinicians' follow-up and referral with education to diabetes nurses if deemed necessary at in-charge clinicians' discretion.
Behavioral: Usual Care
Subjects in Usual CAre will receive standard care with clinicians' usual follow-up and referral with education to diabetes nurses if deemed necessary at in-charge clinicians' discretion.
Active Comparator: Patient Peer Support and Empowerment
30 mentors are themselves diabetes patients who have good self care and are motivated to support their peers. The mentors will be trained to deliver peer support intervention under supervision by a program manager. The 300 diabetes patients (mentees) randomized to the peer support group are the intervention targets of these 30 mentors. Telephone-Linked-Communication (TLC) system will be a tool of the mentors for education to the mentees. TLC system utilizes an automatic, interactive, computer-controlled telephone system to monitor and promote diabetes self-management.
Behavioral: Patient Peer Support and Empowerment
30 mentors are themselves diabetes patients who have good self care and are motivated to support their peers. The mentors will be trained to deliver peer support intervention under supervision by a program manager. The 300 diabetes patients (mentees) randomized to the peer support group are the intervention targets of these 30 mentors. Telephone-Linked-Communication (TLC) system will be a tool of the mentors for education to the mentees. TLC system utilizes an automatic, interactive, computer-controlled telephone system to monitor and promote diabetes self-management.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1) Type 2 diabetic patients with medium or moderate risk for complications (stratified by JADE Program, Care Levels 2 to 4) and followed up 3-4 monthly according to the JADE Program. Based on our 6000-patient registry, these risk levels clearly separate diabetes patients based on risk of future clinical events.
  • 2) Men/women aged 18-70 years (inclusive), functionally independent and with informed written consent.

Exclusion Criteria:

  • 1) Patients with one or no risk factors (low risk, Care Level 1 by JADE Program) as stratified by the JADE Risk Engine.

    2) Patients with reduced life expectancy and unstable mood or major psychiatric conditions.

    3) Patients who cannot communicate in Chinese language.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950716

Contacts
Contact: Juliana Chan, MD 852-26323138 jchan@cuhk.edu.hk
Contact: Gary Ko, MD 852-26461397 garyko@cuhk.edu.hk

Locations
China
Asia Diabetes Foundation Recruiting
Hong Kong, China
Contact: Jennifer Nan, PhD    852-26376605    JH_Nan@cuhk.edu.hk   
Principal Investigator: Juliana Chan, MD         
Sponsors and Collaborators
Chinese University of Hong Kong
Asia Diabetes Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Juliana Chan, Asia Diabetes Foundation
ClinicalTrials.gov Identifier: NCT00950716     History of Changes
Other Study ID Numbers: CRE-2009-079
Study First Received: July 31, 2009
Last Updated: January 6, 2011
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
type II diabetes
peer support
empowerment

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 16, 2014