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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01313949
Other study ID # CRE-2009-087
Secondary ID
Status Completed
Phase N/A
First received March 7, 2011
Last updated July 21, 2014
Start date February 2009
Est. completion date August 2011

Study information

Verified date July 2014
Source Asia Diabetes Foundation
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date August 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Known psychiatric disease

- Physically handicapped to the degree that communication with others is significantly impaired impaired, such as deafness, paraplegia.

- Illiterate

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Training program
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.

Locations

Country Name City State
Hong Kong Diabetes Centre, Tung Wah Eastern Hospital Causeway Bay
Hong Kong Diabetes Hong Kong Central
Hong Kong Diabetes Ambulatory Centre, PYNEH Chai Wan
Hong Kong Diabetes Centre, Kwong Wah Hospital Kowloon
Hong Kong Diabetes Centre, Queen Elizabeth Hospital Kowloon
Hong Kong PMH, Diabetes Care Centre, Princess Margaret Hospital Kowloon
Hong Kong Kwai Chung out-patient clinic Kwai Chung New Territories
Hong Kong Diabetes Ambulatory Care Centre, UCH Kwun Tong Kowloon
Hong Kong Lam Tin Health Clinic Lam Tin
Hong Kong Diabetes Centre, Queen Mary Hospital Pok Fu Lam
Hong Kong Sai Wan Ho Health Centre Sai Wan Ho
Hong Kong CUHK YCK, Prince of Wales Hospital Shatin New Territories
Hong Kong Diabetes & Endocrine Centre, Prince of Wales Hospital Shatin New Territories
Hong Kong Diabetes Centre, North District Hospital Sheung Shui New Territories
Hong Kong Diabetes Centre, Ruttonjee Hospital Wan Chai

Sponsors (1)

Lead Sponsor Collaborator
Asia Diabetes Foundation

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 months No
Secondary 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). 6 months No
Secondary 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 6 months No
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