Impact of Peer Support on Diabetes in China

Study Overview
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Brief Summary
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The prevalence of diabetes has been growing rapidly in developing countries causing a devastating economic burden and increasing demands on healthcare systems. Therefore, there is an urgent need to find cost-effective and multi-faceted approach for diabetes care. Peer support models provide a potentially low-cost, flexible means that is complimentary to the current existing health care services. Trained peer leaders can become qualified extenders to a formal healthcare system, thereby, assisting with the education delivery and bolstering the efforts of the professional staff. To implement a culturally- specific peer support program and determine whether it is acceptable, cost-effective in China is important. This study aims to implement and evaluate biophysical and psychosocial outcomes of a peer support program and to explore it's feasibility and sustainability in China

Official Title
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Impact of Peer Support on Diabetes in China: a Multi-center, Cluster Randomized Controlled Trial

Conditions
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Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes

Intervention / Treatment
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* Behavioral: peer support
* Other: usual education lectures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes with voluntary participation and have signed the Patient Informed Consent Sheet reside in stable places during the intervention period Exclusion Criteria: Patients with reduced life expectancy and unstable mood or major psychiatric conditions suffering from cancer and have been receiving radiotherapy and/ or chemotherapy in the past half year enrolling in other research program at present

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: peer support<br>Patients are divided into small groups and assigned with peer leaders for twelve months according to their residence. Besides the same training and follow-ups as the control arm, patients from intervention groups are suggested and encouraged to take part in the group activities with the peer leaders per month. And if possible, casual activities (such as phone call, chatting, short message; physical exercise, group member family visiting，going to supermarket together, etc.)are also recommended | Behavioral: peer support<br> <br> * Other names: peer education, peer coach;Other: usual education lectures<br> <br> |
| Active Comparator: usual education<br>Patients attend the usual self-management education and communicate with the professionals every two months, getting the information on diabetes diet, exercise, glucose monitor, etc. besides that the group members should attend three follow ups at baseline,6 and 12 months. | Other: usual education lectures<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HbA1c at 6 months,12 months |  | baselline,6months,12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline blood pressure at 6 months,12 months |  | baseline,6 months,12months | 
| Change from Baseline months BMI at 6 months,12 months |  | baseline,6 months,12months | 
| Change from Baseline months blood liquids at 6 months,12 months |  | baseline,6 months,12months | 
| Change from Baseline months blood glucose at 6 months,12 months |  | baseline,6 months,12months | 
| Change from baseline in diabetes self-care activities scales at 6 months,12months |  | baseline,6 months,12months | 
| Change from baseline in depression scales at 6 months,12months |  | baseline,6 months,12months | 
| Change from baseline in medication adherence scales at 6 months,12months |  | baseline,6 months,12months | 
| Change from baseline in quality of life scales at 6 months,12months |  | baseline,6 months,12months | 
| Change from baseline in diabetes self-efficacy scales at 6 months,12months |  | baseline,6 months,12months | 
| Change from baseline in diabetes knowledge scales at 6 months,12months |  | baseline,6 months, 12 months | 
| Change from baseline in positive and negative affectivity at 6 months,12months |  | baseline, 6 months,12months | 
| Change from baseline in events of hypoglycemia at 6 months,12months |  | baseline,6 months,12months | 
| Change from baseline advanced glycation end products at 6 months,12months |  | baseline ,6 months,12months | 
| cost |  | baseline,6 months,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes,peer support