Impact of Peer Support on Diabetes in China: a Multi-center, Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change from Baseline HbA1c at 6 months,12 months
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •with voluntary participation and have signed the Patient Informed Consent Sheet
- •reside in stable places during the intervention period
排除标准
- •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
结局指标
主要结局
Change from Baseline HbA1c at 6 months,12 months
时间窗: baselline,6months,12months
次要结局
- 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)
研究者
Zilin Sun
director of endocrine department
Zhongda Hospital