Peer Support in Diabetes Management - Insulin Peer Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 11
- 主要终点
- Change from Baseline HbA1c at 6 and 12 months
研究概览
简要总结
This project will develop a combined model of the Shanghai Integration Model and peer support for diabetes self-management with a special focus on appropriate insulin use.
详细描述
The development of contemporary diabetes care offers new hope for long and satisfying lives of those with the disease, but also provides increased challenges for integration across the many dimensions of care (varied medications in addition to insulin, specialty services, diet, physical activity, stress management, etc.) and across the many who contribute to care (specialists, primary care providers, nurses, dietitians and patient educators, family members, friends, worksites). The Shanghai Integration Model (SIM) has made great strides to integrating specialty/hospital care with primary/community care. The addition of peer support can enhance patient engagement within that integrated care. Peer support can also integrate care with the daily behaviors and patterns that optimal diabetes management requires and with the family members and others in individuals' daily lives who can support diabetes management.
The "Insulin Peer Support" project is a sub-project of "Peer Support in Diabetes Care", with special focus on appropriate insulin use in the community, to help overcome barriers in insulin treatment and improve treatment compliance. This project will develop a peer support model for diabetes management in Chinese patients undergoing insulin treatment and evaluate its effectiveness in a randomized controlled trial of 10 CHCs in Shanghai.
The project is a collaboration among the Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, the Shanghai Diabetes Institute,the Shanghai Municipal Commission of Health and Family Planning, the Shanghai Centers for Disease Control, and, at the University of North Carolina-Chapel Hill, Peers for Progress, widely recognized for its leadership in promoting peer support in health care and prevention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Has type 2 diabetes
- •Receiving treatment at participating community health center
- •Currently using insulin or prescribed insulin but not currently using insulin
排除标准
- •Severe mental illness (severe depression, schizophrenia, bipolar disorder, obsessive compulsive disorder, panic disorder, PTSD, borderline personality disorder, etc.)
研究组 & 干预措施
Peer Support Intervention
The experimental group will receive the peer support intervention for 12 months.
干预措施: Peer Support (Behavioral)
Control
Usual care
结局指标
主要结局
Change from Baseline HbA1c at 6 and 12 months
时间窗: Baseline, 6 months, 12 months
HbA1c (%)
次要结局
- Change from Baseline Hemoglobin at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Blood Lipids at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Fasting Blood Glucose at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Blood Pressure at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline BMI at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Red Blood Cell Count at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Mean Corpuscular Volume at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Mean Corpuscular Hemoglobin at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Liver Functioning at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Bilirubin at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Blood Urea at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Serum Creatinine at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Uric Acid at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Urine Albumin/Creatinine Ratio at 6 and 12 months(Baseline, 6 months, 12 months)
- Change in Insulin Functioning at 6 and 12 months(6 months, 12 months)
- Change in C-peptides at 6 and 12 months(6 months, 12 months)
- Change from Baseline Diabetes Self Care Behaviors at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Medication Adherence at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline General Quality of Life at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Diabetes Quality of Life at 6 and 12 months(Baseline, 6 months, 12 months)
- Change from Baseline Depression at 6 and 12 months(Baseline, 6 months, 12 months)
- Change in Community Support for Diabetes at 6 and 12 months(6 months, 12 months)
- Change in Healthcare Utilization at 6 and 12 months(6 months, 12 months)
- Change from Baseline Insulin Attitudes at 6 and 12 months(Baseline, 6 months, 12 months)
研究者
Weiping Jia
Professor, President of Shanghai 6th People's Hospital, Director of Shanghai Institute of Diabetes
Shanghai 6th People's Hospital