PEARL Program: Empowerment Program for Patients With Type 2 Diabetes (HK4)
PEARL
Peer Support, Empowerment and Remote Communication Linked by Information Technology (PEARL): A Multi-Component Program to Improve Community-Based Diabetes Care
1 other identifier
interventional
632
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Sep 2009
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2009
CompletedFirst Posted
Study publicly available on registry
August 3, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedAugust 25, 2015
August 1, 2015
5.4 years
July 31, 2009
August 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Glycemic control
one year
Body weight
one year
Blood pressure
one year
Lipid levels
one year
Secondary Outcomes (1)
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).
One year
Study Arms (2)
Usual care
ACTIVE COMPARATORThe '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.
Patient Peer Support and Empowerment
ACTIVE COMPARATOR30 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \) 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.
- \) Men/women aged 18-70 years (inclusive), functionally independent and with informed written consent.
You may not qualify if:
- \) Patients with one or no risk factors (low risk, Care Level 1 by JADE Program) as stratified by the JADE Risk Engine.
- \) Patients with reduced life expectancy and unstable mood or major psychiatric conditions.
- \) Patients who cannot communicate in Chinese language.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese University of Hong Konglead
- Asia Diabetes Foundationcollaborator
Study Sites (1)
Asia Diabetes Foundation
Hong Kong, China
Related Publications (2)
Yeung RO, Cai JH, Zhang Y, Luk AO, Pan JH, Yin J, Ozaki R, Kong APS, Ma R, So WY, Tsang CC, Lau KP, Fisher E, Goggins W, Oldenburg B, Chan J. Determinants of hospitalization in Chinese patients with type 2 diabetes receiving a peer support intervention and JADE integrated care: the PEARL randomised controlled trial. Clin Diabetes Endocrinol. 2018 Mar 7;4:5. doi: 10.1186/s40842-018-0055-6. eCollection 2018.
PMID: 29541481DERIVEDChan JC, Sui Y, Oldenburg B, Zhang Y, Chung HH, Goggins W, Au S, Brown N, Ozaki R, Wong RY, Ko GT, Fisher E; JADE and PEARL Project Team. Effects of telephone-based peer support in patients with type 2 diabetes mellitus receiving integrated care: a randomized clinical trial. JAMA Intern Med. 2014 Jun;174(6):972-81. doi: 10.1001/jamainternmed.2014.655.
PMID: 24781960DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- Chair Professor of Medicine and Therapeutics
Study Record Dates
First Submitted
July 31, 2009
First Posted
August 3, 2009
Study Start
September 1, 2009
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
August 25, 2015
Record last verified: 2015-08