DiabetesPLATINUMNCT01313949
PLATINUM Program: A Feasibility Study on a Train-the-trainer Course on Peer Support for People With Type 2 Diabetes
A study testing Training program in people with Diabetes, run by Asia Diabetes Foundation at 15 sites in Hong Kong.
Trial summary
The investigators hypothesize that a training course to people with diabetes on peer support and empowerment will improve their glycemic parameters, knowledge on diabetes and level of self efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 15 sitesHong Kong
- Study dates
- Feb 2009to Aug 2011
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese people with type 2 diabetes
- 18-75 years of age
- Good glycaemic control (HbA1c <7%) and remain stable in past 1 year
- Willing to complete the structured training curriculum to prepare themselves as peer leaders
- Fluent in Cantonese
Who cannot join
- Known psychiatric disease
- Physically handicapped to the degree that communication with others is significantly impaired impaired, such as deafness, paraplegia.
- Illiterate
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Hong Kong15 sites
Diabetes Centre, Tung Wah Eastern Hospital
Causeway Bay
Diabetes Hong Kong
Central
Diabetes Ambulatory Centre, PYNEH
Chai Wan
Diabetes Centre, Kwong Wah Hospital
Kowloon
Diabetes Centre, Queen Elizabeth Hospital
Kowloon
PMH, Diabetes Care Centre, Princess Margaret Hospital
Kowloon
Kwai Chung out-patient clinic
Kwai Chung, New Territories
Diabetes Ambulatory Care Centre, UCH
Kwun Tong, Kowloon
Lam Tin Health Clinic
Lam Tin
Diabetes Centre, Queen Mary Hospital
Pok Fu Lam
Sai Wan Ho Health Centre
Sai Wan Ho
CUHK YCK, Prince of Wales Hospital
Shatin, New Territories
Diabetes & Endocrine Centre, Prince of Wales Hospital
Shatin, New Territories
Diabetes Centre, North District Hospital
Sheung Shui, New Territories
Diabetes Centre, Ruttonjee Hospital
Wan Chai
About this study
Official title: Peer Leaders Accelerated Training Initiative to Unleash Potential of Mentorship (PLATINUM) Program: A Feasibility Study on a Train-the-trainer Course on Peer Support for People With Type 2 Diabetes
The investigators hypothesize that a training course to people with diabetes on peer support and empowerment will improve their glycemic parameters, knowledge on diabetes and level of self efficacy. This group of trained patients (peer leaders) should be competent to teach and help other patients with diabetes through peer support and empowerment on better self management of their diabetes.
Read the detailed description
In our attempt to improve diabetes self care, one important component is the diabetes patients who should have the best incentive to improve their care levels and reduce their complication risk, provided that they are appropriately trained, informed, educated and supported. According to the World Health Organization (WHO) Innovative Care for Chronic Conditions framework, expert patients are recommended to be included in the health care team to make them prepared, motivated and informed decision makers to preserve health and improve clinical outcomes. In a recent report on WHO consultation, peer support interventions are considered to have enormous potentials to make self management an effective component of chronic care.
Peer support is defined as support from a person who has experiential knowledge of a specific behavior or stressor and similar characteristics as the target population. Thus people with common illness experience can share knowledge and experience in a less hierarchical and reciprocal relationship compared to that between patients and health care professionals. A number of programs including health worker-led groups with peer exchange, peer-led face-to-face self management programs, peer coaches and remote peer support have reported encouraging results with short term improvement in metabolic or cognitive-psychological-behavioral dimensions, although these results are often limited by non-sustainability of changes and insufficient reach or adoption of programs by patients or health care workers. In the WHO report, health care experts from various disciplines concluded that whilst peer support is a promising approach for diabetes management, issues regarding methods of organization, types of programs and their integration with other clinical and outreach services remain to be addressed. Of note, there is a paucity of similar data in developing and low income areas which are hit hardest by this epidemic and where peer support program may offer great promise to make diabetes prevention and care program more sustainable and accessible, if implemented and evaluated systematically.
Health professionals, especially diabetes nursing specialists, have been training diabetes patients on the understanding and self-caring of diabetes. However, with the emerging concept and preliminary evidence of success in the role of "peer advisors" in diabetes to lead self care courses for other fellow patients, a train-the-trainer program to develop "expert patients" is essential. On top of factual knowledge on diabetes as a disease, context of this program needs to cover include communication and empowerment skill, basic knowledge on psychology, stress management, social support, empowerment, healthy lifestyle including diet and physical activity.
In the evaluation of the programs, there is a need to define the qualities and roles of the peer supporter, design programs which integrate and complement formal health services, identify optimal mix of modalities of intervention, types and dose response of these interventions and evaluate acceptability and effectiveness of these programs in different cultures. Other evaluation indexes include effects of programs on behavioral changes, knowledge and attitudes, functionality, clinical care as well as their cost effectiveness, reach, implementation-consistency, adoption and maintenance of effects over time.
- Conditions
- Diabetes
- Being tested
- Training program
- Keywords
- Diabetes, Peer Support, Structured Care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training programOther
These diabetes patients will undergo a 32-hour 'Train the trainer' program (4 workshops, 8-hours each) led by health care experts in nutrition, physical activity, psychology and neuro-linguistic program [NLP] trainer to ensure the adequacy of knowledge and skills of these mentors.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | A total of 90 patients with diabetes will be recruited. Thirty will be selected for the training course and the other 60 will be compared as controls. These controls will receive their usual diabetes care. |
| Peer leader training | Experimental | Peer leaders are people with diabetes who had volunteered to undertake an extensive program of training. The purpose of this training is to make them effective in the provision of support and advice to their peers on a one-to-one basis via telecommunication.
These diabetes patients will undergo a 32-hour 'Train the trainer' program (4 workshops, 8-hours each) led by health care experts in nutrition, physical activity, psychology and neuro-linguistic program [NLP] trainer to ensure the adequacy of knowledge and skills of these mentors. Receives: Other: Training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effectiveness of the training program in improving glycemic parameters in diabetic patients before and after the training.
Metabolic parameters, such as HbA1c, Body Mass Index (BMI), Lipid Profile, etc. will be measured at specific time points before and after the training
Measured: 6 months
Secondary outcomes (2)
To assess the efficacy of the training on the attitudes, behaviours and self-efficacy of the participants as compared to the control patients
The psychosocial-behavior assessment will include using the Summary of Diabetes Self- Care Activities (SDSCA), Diabetes Empowerment Scale (DES), Depression Anxiety Stress Scale-21 (DASS21), General Health Questionnaire (GHQ12), Euro Quality of Life (EQ5D) \& Patient Health Questionniare (PHQ9).
Measured: 6 months
To assess the efficacy of the training in improving the participants' knowledge of diabetes, as compared to the control patients.
An evaluation feedback form will be completed by all participants after each workshop
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asia Diabetes Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Wong, Principal investigator, Prince of Wales Hospital, Shatin, HKShimen Au, Principal investigator, Ruttonjee & Tang Shiu Kin Hospitals, Wan Chai, HK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313949
- Sponsor's protocol ID
- CRE-2009-087
- Acronym
- PLATINUM
- Status last verified
- Jul 2014
- First submitted
- 7 Mar 2011
- Last updated
- 23 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Leaders Accelerated Training Initiative to Unleash Potential of Mentorship (PLATINUM) Program: A Feasibility Study on a Train-the-trainer Course on Peer Support for People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01313949
- Acronym / sponsor ID
- PLATINUM / CRE-2009-087
- Conditions
- Diabetes
- Keywords
- Diabetes, Peer Support, Structured Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Asia Diabetes FoundationUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Mar 2011 (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.
The investigators hypothesize that a training course to people with diabetes on peer support and empowerment will improve their glycemic parameters, knowledge on diabetes and level of self efficacy. This group of trained patients (peer leaders) should be competent to teach and help other patients with diabetes through peer support and empowerment on better self management of their diabetes.
Detailed description
In our attempt to improve diabetes self care, one important component is the diabetes patients who should have the best incentive to improve their care levels and reduce their complication risk, provided that they are appropriately trained, informed, educated and supported. According to the World Health Organization (WHO) Innovative Care for Chronic Conditions framework, expert patients are recommended to be included in the health care team to make them prepared, motivated and informed decision makers to preserve health and improve clinical outcomes. In a recent report on WHO consultation, peer support interventions are considered to have enormous potentials to make self management an effective component of chronic care.
Peer support is defined as support from a person who has experiential knowledge of a specific behavior or stressor and similar characteristics as the target population. Thus people with common illness experience can share knowledge and experience in a less hierarchical and reciprocal relationship compared to that between patients and health care professionals. A number of programs including health worker-led groups with peer exchange, peer-led face-to-face self management programs, peer coaches and remote peer support have reported encouraging results with short term improvement in metabolic or cognitive-psychological-behavioral dimensions, although these results are often limited by non-sustainability of changes and insufficient reach or adoption of programs by patients or health care workers. In the WHO report, health care experts from various disciplines concluded that whilst peer support is a promising approach for diabetes management, issues regarding methods of organization, types of programs and their integration with other clinical and outreach services remain to be addressed. Of note, there is a paucity of similar data in developing and low income areas which are hit hardest by this epidemic and where peer support program may offer great promise to make diabetes prevention and care program more sustainable and accessible, if implemented and evaluated systematically.
Health professionals, especially diabetes nursing specialists, have been training diabetes patients on the understanding and self-caring of diabetes. However, with the emerging concept and preliminary evidence of success in the role of "peer advisors" in diabetes to lead self care courses for other fellow patients, a train-the-trainer program to develop "expert patients" is essential. On top of factual knowledge on diabetes as a disease, context of this program needs to cover include communication and empowerment skill, basic knowledge on psychology, stress management, social support, empowerment, healthy lifestyle including diet and physical activity.
In the evaluation of the programs, there is a need to define the qualities and roles of the peer supporter, design programs which integrate and complement formal health services, identify optimal mix of modalities of intervention, types and dose response of these interventions and evaluate acceptability and effectiveness of these programs in different cultures. Other evaluation indexes include effects of programs on behavioral changes, knowledge and attitudes, functionality, clinical care as well as their cost effectiveness, reach, implementation-consistency, adoption and maintenance of effects over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –A total of 90 patients with diabetes will be recruited. Thirty will be selected for the training course and the other 60 will be compared as controls. These controls will receive their usual diabetes care. |
| Peer leader training | Experimental | Other: Training programPeer leaders are people with diabetes who had volunteered to undertake an extensive program of training. The purpose of this training is to make them effective in the provision of support and advice to their peers on a one-to-one basis via telecommunication. These diabetes patients will undergo a 32-hour 'Train the trainer' program (4 workshops, 8-hours each) led by health care experts in nutrition, physical activity, psychology and neuro-linguistic program [NLP] trainer to ensure the adequacy of knowledge and skills of these mentors. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese people with type 2 diabetes
- 18-75 years of age
- Good glycaemic control (HbA1c <7%) and remain stable in past 1 year
- Willing to complete the structured training curriculum to prepare themselves as peer leaders
- Fluent in Cantonese
Key exclusion criteria (3 listed)
- Known psychiatric disease
- Physically handicapped to the degree that communication with others is significantly impaired impaired, such as deafness, paraplegia.
- Illiterate
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 |
|---|---|---|
| Training programThese diabetes patients will undergo a 32-hour 'Train the trainer' program (4 workshops, 8-hours each) led by health care experts in nutrition, physical activity, psychology and neuro-linguistic program [NLP] trainer to ensure the adequacy of knowledge and skills of these mentors. | Other | Peer leader training |
Primary outcome
To assess the effectiveness of the training program in improving glycemic parameters in diabetic patients before and after the training.
Time frame: 6 months
Metabolic parameters, such as HbA1c, Body Mass Index (BMI), Lipid Profile, etc. will be measured at specific time points before and after the training
2 secondary outcomes
To assess the efficacy of the training on the attitudes, behaviours and self-efficacy of the participants as compared to the control patients
Time frame: 6 months
To assess the efficacy of the training in improving the participants' knowledge of diabetes, as compared to the control patients.
Time frame: 6 months
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 23 Jul 2014.
- For more information on this trial and others conducted by the Asia Diabetes Foundation.Link provided by the sponsor.
Related trials for Diabetes
Recruiting
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
Diabetes Mellitus, Psychological Distress
Not yet recruiting
The Effect of Individualized Nursing Interventions on Glycemic Variability and Self-Management in Type 2 Diabetes
Type 2 Diabetes Mellitus (T2DM)
Not yet recruitingObservational study
Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults
Obesity, Diabetes
Active, not recruitingObservational study
Non-Invasive MASLD Diagnosis & T2D Remission Biomarkers
MASLD, T2DM (Type 2 Diabetes Mellitus)
Recruiting
Effects of Medisinstart for Type 2 Diabetes
Type 2 Diabetes
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.
Rebecca Wong principal investigator
Prince of Wales Hospital, Shatin, HK
Shimen Au principal investigator
Ruttonjee & Tang Shiu Kin Hospitals, Wan Chai, HK
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training program in people with Diabetes, run by Asia Diabetes Foundation at 15 sites in Hong Kong.
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 5 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 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Hong Kong. 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?
To assess the effectiveness of the training program in improving glycemic parameters in diabetic patients before and after the training. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2014.