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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Hong Kong

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 groups in NCT01313949
Study groupRoleWhat they receive
Usual CareNo interventionA 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 trainingExperimentalPeer 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted14 Mar 2011 (estimated)
  2. Study startFeb 2009
  3. Primary completionFeb 2011
  4. Study completionAug 2011

Resources

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)
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

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.

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