DiabetesPEARLNCT00950716
PEARL Program: Empowerment Program for Patients With Type 2 Diabetes (HK4)
A study testing Patient Peer Support and Empowerment in people with Diabetes, run by Chinese University of Hong Kong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Patient Peer Support and Empowerment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer Support, Empowerment and Remote Communication Linked by Information Technology (PEARL): A Multi-Component Program to Improve Community-Based Diabetes Care
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.
Read more
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.
Read the detailed description
In this global epidemic of diabetes and obesity, more than 60% of affected people will come from Asia with the most rapid increase in the young to middle aged group. This rapid increase in young onset diabetes will have major implications on health care costs, quality of life and societal productivity. Despite the amassing body of evidence supporting the highly preventable nature of diabetes and associated complications, there are multiple barriers in the implementation of quality diabetes care. Apart from issues relating to health care systems and reimbursement, the silent nature of diabetes and associated complications as well as the complex nature of care protocols which requires frequent evaluation of clinical and laboratory parameters and the need for diabetes patients to adhere to long term medications and self care are important factors.
Diabetes is a prototype of chronic diseases covering the full spectrum of health promotion, disease prevention, management and rehabilitation. To achieve these inter-dependent goals, multiple levels of expertise and support are needed to preserve health, prevent complications and enhance quality of life. A successful diabetes care program depends on informed decisions of motivated care providers and diabetes patients who require periodic comprehensive assessments for risk stratification and individualized management which include education, assessments, feedback and technologies.
According to the International Diabetes Federation (IDF) global guidelines (www.idf.org), standard diabetes care include the delivery of culturally sensitive care, cultivation of relationship between care providers and diabetes patients, offer of annual surveillance, goal setting on care plans and targets, adherence to protocol, provision of access to patient-centred care using a multidisciplinary team, establishment of a registry for recall, provision of telephone contact and patient support group and a quality assurance and improvement program. Comprehensive care includes all components of standard of care together with access of diabetes patients to their own data and decision support.
To achieve this ambitious goal, delivery of chronic care must be integrated with effective self management on a long term basis. People with diabetes need to acquire knowledge, skills and attitudes to exercise self discipline on food choices, physical activity, self monitoring and management of negative emotions. To this end, experts have identified 6 key resources and support for self management including 1) individualized assessment, 2) collaborative goal setting, 3) skills enhancement, 4) follow-up and support, 5) access to resources, and 6) continuity of quality clinical care.
However, most studies which use cognitive and psychological strategies to effect behavioral changes have reported high rates of relapse despite initial success, often due to negative external or social influences. Thus, to enhance self management, there is a need to take into consideration both internal needs (assessment of individual needs, learning skills and goal setting) and external support (e.g. families, organizations, neighborhoods, and communities) to encourage and reinforce the use of learned skills to sustain positive behavior and self management on a long term basis. Adding to these emerging concepts in behavioral medicine is equifinality, i.e. diverse approaches may achieve similar end. Thus, a multi-component program offering a broad range of intervention approaches may tailor the pluralistic needs of people with diabetes or chronic disease.
Aims of the Study:
- To quantify the impacts of peer support on self management skills, quality of life (QOL) and cognitive-psychological-behavioral parameter.
- To quantify effects of various components of self management skills and cognitive- psychological-behavioral parameters on metabolic control, care processes and QOL.
- To examine the user acceptability (including health care team and diabetes patients) and cost effectiveness of this multi-component system in improving diabetes care in the community..
- Conditions
- Diabetes
- Being tested
- Patient Peer Support and Empowerment, Usual Care
- Keywords
- type II diabetes, peer support, empowerment
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Peer Support and EmpowermentBehavioural
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.
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | 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. Receives: Behavioral: Usual Care |
| Patient Peer Support and Empowerment | Active comparator | 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. Receives: Behavioral: Patient Peer Support and Empowerment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Measured: one year
Body weight
Measured: one year
Blood pressure
Measured: one year
Lipid levels
Measured: 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).
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 632 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Asia Diabetes Foundation
- Responsible party
- Principal investigator, Juliana Chan, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950716
- Sponsor's protocol ID
- CRE-2009-079
- Acronym
- PEARL
- Status last verified
- Aug 2015
- First submitted
- 31 Jul 2009
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29541481Chan 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.
PubMed 24781960
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support, Empowerment and Remote Communication Linked by Information Technology (PEARL): A Multi-Component Program to Improve Community-Based Diabetes Care
- ClinicalTrials.gov ID
- NCT00950716
- Acronym / sponsor ID
- PEARL / CRE-2009-079
- Conditions
- Diabetes
- Keywords
- type II diabetes, peer support, empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Asia Diabetes Foundation
- Study start
- Sep 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 3 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this global epidemic of diabetes and obesity, more than 60% of affected people will come from Asia with the most rapid increase in the young to middle aged group. This rapid increase in young onset diabetes will have major implications on health care costs, quality of life and societal productivity. Despite the amassing body of evidence supporting the highly preventable nature of diabetes and associated complications, there are multiple barriers in the implementation of quality diabetes care. Apart from issues relating to health care systems and reimbursement, the silent nature of diabetes and associated complications as well as the complex nature of care protocols which requires frequent evaluation of clinical and laboratory parameters and the need for diabetes patients to adhere to long term medications and self care are important factors.
Diabetes is a prototype of chronic diseases covering the full spectrum of health promotion, disease prevention, management and rehabilitation. To achieve these inter-dependent goals, multiple levels of expertise and support are needed to preserve health, prevent complications and enhance quality of life. A successful diabetes care program depends on informed decisions of motivated care providers and diabetes patients who require periodic comprehensive assessments for risk stratification and individualized management which include education, assessments, feedback and technologies.
According to the International Diabetes Federation (IDF) global guidelines (www.idf.org), standard diabetes care include the delivery of culturally sensitive care, cultivation of relationship between care providers and diabetes patients, offer of annual surveillance, goal setting on care plans and targets, adherence to protocol, provision of access to patient-centred care using a multidisciplinary team, establishment of a registry for recall, provision of telephone contact and patient support group and a quality assurance and improvement program. Comprehensive care includes all components of standard of care together with access of diabetes patients to their own data and decision support.
To achieve this ambitious goal, delivery of chronic care must be integrated with effective self management on a long term basis. People with diabetes need to acquire knowledge, skills and attitudes to exercise self discipline on food choices, physical activity, self monitoring and management of negative emotions. To this end, experts have identified 6 key resources and support for self management including 1) individualized assessment, 2) collaborative goal setting, 3) skills enhancement, 4) follow-up and support, 5) access to resources, and 6) continuity of quality clinical care.
However, most studies which use cognitive and psychological strategies to effect behavioral changes have reported high rates of relapse despite initial success, often due to negative external or social influences. Thus, to enhance self management, there is a need to take into consideration both internal needs (assessment of individual needs, learning skills and goal setting) and external support (e.g. families, organizations, neighborhoods, and communities) to encourage and reinforce the use of learned skills to sustain positive behavior and self management on a long term basis. Adding to these emerging concepts in behavioral medicine is equifinality, i.e. diverse approaches may achieve similar end. Thus, a multi-component program offering a broad range of intervention approaches may tailor the pluralistic needs of people with diabetes or chronic disease.
Aims of the Study:
- To quantify the impacts of peer support on self management skills, quality of life (QOL) and cognitive-psychological-behavioral parameter.
- To quantify effects of various components of self management skills and cognitive- psychological-behavioral parameters on metabolic control, care processes and QOL.
- To examine the user acceptability (including health care team and diabetes patients) and cost effectiveness of this multi-component system in improving diabetes care in the community..
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Behavioral: Usual CareThe '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 comparator | Behavioral: Patient Peer Support and Empowerment30 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Peer Support and Empowerment30 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. | Behavioural | Patient Peer Support and Empowerment |
| Usual CareSubjects 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. | Behavioural | Usual care |
Primary outcome
Glycemic control
Time frame: one year
Body weight
Time frame: one year
Blood pressure
Time frame: one year
Lipid levels
Time frame: one year
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2015.
- Derived from this study: PubMed 29541481Yeung 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.
- Derived from this study: PubMed 24781960Chan 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.
- details of the Peers for Progress Grant and its aims; and the grantees in 2009Link provided by the sponsor.
- Works, including PEARL program, of Asia Diabetes FoundationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Peer Support and Empowerment in people with Diabetes, run by Chinese University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00950716, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2015.