Impact of Peer Support on Diabetes in China

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02119572
• Other study ID #: Zhongdaendo1
• Status: Recruiting
• Phase: N/A
• First received: April 15, 2014
• Last updated: April 18, 2014

Study information

• Verified date: April 2014
• Source: Zhongda Hospital
• Contact: Bo Xie, MPH
• Phone: 86-25-83272526
• Email: boxxie80[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. type 2 diabetes

2. with voluntary participation and have signed the Patient Informed Consent Sheet

3. reside in stable places during the intervention period

Exclusion Criteria:

1. Patients with reduced life expectancy and unstable mood or major psychiatric conditions

2. suffering from cancer and have been receiving radiotherapy and/ or chemotherapy in the past half year

3. enrolling in other research program at present

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes
• Endocrine System Diseases
• Glucose Metabolism Disorders
• Metabolic Diseases

Intervention

Behavioral:
• peer support

Other:
• usual education lectures

Locations

Country	Name	City	State
China	Liuhe	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline HbA1c at 6 months,12 months		baselline,6months,12months	Yes
Secondary	Change from Baseline blood pressure at 6 months,12 months		baseline,6 months,12months	Yes
Secondary	Change from Baseline months BMI at 6 months,12 months		baseline,6 months,12months	Yes
Secondary	Change from Baseline months blood liquids at 6 months,12 months		baseline,6 months,12months	Yes
Secondary	Change from Baseline months blood glucose at 6 months,12 months		baseline,6 months,12months	Yes
Secondary	Change from baseline in diabetes self-care activities scales at 6 months,12months		baseline,6 months,12months	Yes
Secondary	Change from baseline in depression scales at 6 months,12months		baseline,6 months,12months	Yes
Secondary	Change from baseline in medication adherence scales at 6 months,12months		baseline,6 months,12months	Yes
Secondary	Change from baseline in quality of life scales at 6 months,12months		baseline,6 months,12months	Yes
Secondary	Change from baseline in diabetes self-efficacy scales at 6 months,12months		baseline,6 months,12months	Yes
Secondary	Change from baseline in diabetes knowledge scales at 6 months,12months		baseline,6 months, 12 months	Yes
Secondary	Change from baseline in positive and negative affectivity at 6 months,12months		baseline, 6 months,12months	Yes
Secondary	Change from baseline in events of hypoglycemia at 6 months,12months		baseline,6 months,12months	Yes
Secondary	Change from baseline advanced glycation end products at 6 months,12months		baseline ,6 months,12months	Yes
Secondary	cost		baseline,6 months,12 months	Yes