Peer Support to Enhance the Shanghai Integration Model of Diabetes Care: Dissemination to 12 Communities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,160
- 试验地点
- 16
- 主要终点
- Change from Baseline HbA1c and at 12 months
研究概览
简要总结
This project will disseminate a community-level intervention that integrates peer support from Community Self-Management Groups (CSMGs) and primary care through Community Health Centers (CHC). The model and program materials were developed and refined from the first year of implementation within community health centers in Shanghai. This project will be implemented in 12 communities in 6 districts across Shanghai, representing a diverse cross section of the population. A total of 1440 subjects will be recruited from the 12 intervention communities and 720 control subjects will be recruited from 4 control communities.
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.
This project will disseminate a community-level intervention that integrates peer support from Community Self-Management Groups (CSMGs) and primary care through Community Health Centers (CHC). The model and program materials were developed and refined from the first year of implementation within community health centers in Shanghai. This project will be implemented in 12 communities in 6 districts across Shanghai, representing a diverse cross section of the population. A total of 1440 subjects will be recruited from the 12 intervention communities and 720 control subjects will be recruited from 4 control communities.
The program is a collaboration among the Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, the Shanghai Diabetes Institute, the National Office for Primary Diabetes Care, the Shanghai Municipal Health Commission, the Shanghai Municipal Center for Disease Control and Prevention, 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.
Collaborators:
Shanghai Sixth People's Hospital Shanghai Jiao Tong University Shanghai Diabetes Institute National Office for Primary Diabetes Care Shanghai Municipal Health Commission Shanghai Municipal Center for Disease Control and Prevention University of North Carolina at Chapel Hill, Peers for Progress
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age ≥ 18
- •Has type 2 diabetes or prediabetes
- •Patient at participating CHC
- •Intervention group: 120 subjects at each of 12 CHCs
- •~40 patients (Pre-diabetes including IFG or IGT)
- •~40 patients (Diabetics with poor control, FPG≥9.7 mmol/L)
- •~40 patients (Newly-diagnosed diabetics within 2 years)
- •Control group: 240 control subjects at each of 2 CHCs (Yichuan and Zhaoxiang) and 120 control subjects at each of 2 CHCs (Xuhang and Waigang)
- •o (Yichuan and Zhaoxiang)
- •~80 patients (Pre-diabetes including IFG or IGT)
- •~80 patients (Diabetics with poor control, FPG≥9.7 mmol/L)
- •~80 patients (Newly-diagnosed diabetics within 2 years)
- •o (Xuhang and Waigang)
- •~40 patients (Pre-diabetes including IFG or IGT)
- •~40 patients (Diabetics with poor control, FPG≥9.7 mmol/L)
- •~40 patients Newly-diagnosed diabetics within 2 years)
排除标准
- •- No serious mental illness (i.e. major depression, schizophrenia, bipolar disorder, obsessive compulsive disorder, panic disorder, post-traumatic stress disorder, borderline personality disorder)
- •Withdrawal criteria:
- •- No longer a patient at participating CHC (moved, deceased, extended hospitalization)
研究组 & 干预措施
Intervention Group
Subjects will receive usual care from community health center staff. In addition, they will also receive a variety of community-level and individual-level interventions, categorized broadly into three levels.
At the community level, subjects will receive the 5 Key Diabetes Messages that Everyone Should Know and the 6 Modules of Basic Diabetes Education. At the individual level, subjects and their families will be invited to participate in group activities, co-organized by community health staff, CHC staff, and CSMG peer leaders. Subjects will receive in-person peer support through these group activities, with follow up through telephone calls and text messaging. For subjects that have poorly controlled diabetes or are experiencing emotional distress related to their diabetes, CSMG peer leaders will work closely with them to help them solve problems around their diabetes.
干预措施: Peer Support Integrated with Primary Care (Behavioral)
Control Group
Subjects in the control group will receive usual care from community health center staff.
结局指标
主要结局
Change from Baseline HbA1c and at 12 months
时间窗: Baseline, 12 months
HbA1c (%)
次要结局
- Change from Baseline Hemoglobin and at 12 months(Baseline, 12 months)
- Change from Baseline Red Blood Cell Count and at 12 months(Baseline, 12 months)
- Change from Baseline Mean Corpuscular Volume and at 12 months(Baseline, 12 months)
- Change from Baseline Fasting Blood Glucose and at 12 months(Baseline, 12 months)
- Change from Baseline Blood Pressure and at 12 months(Baseline, 12 months)
- Change from Baseline Uric Acid and at 12 months(Baseline, 12 months)
- Change from Baseline Depression and 12 months(Baseline, 12 months)
- Change from Baseline Insulin Attitudes and 12 months(Baseline, 12 months)
- Change in Neighborhood Interactions and 12 months(Baseline, 12 months)
- Change from Baseline Mean Corpuscular Hemoglobin and at 12 months(Baseline, 12 months)
- Change from Baseline Urine Albumin/Creatinine Ratio and at 12 months(Baseline, 12 months)
- Change from Baseline BMI and at 12 months(Baseline, 12 months)
- Change from Baseline Blood Lipids and at 12 months(Baseline, 12 months)
- Change from Baseline Waist circumference and at 12 months(Baseline, 12 months)
- Change from Baseline Blood Urea and at 12 months(Baseline, 12 months)
- Change from Baseline Serum Creatinine and at 12 months(Baseline, 12 months)
- Change from Baseline General Quality of Life and 12 months(Baseline, 12 months)
- Change in Peer Support Engagement and Health Care Utilization and 12 months(Baseline, 12 months)
- Change from Baseline Liver Functioning and at 12 months(Baseline, 12 months)
- Change from Baseline Bilirubin and at 12 months(Baseline, 12 months)
- Change in Insulin Functioning at 6 and 12 months(Baseline, 12 months)
- Change in C-peptides at 6 and 12 months(Baseline, 12 months)
- Change in CRP at 6 and 12 months(Baseline, 12 months)
- Change from Baseline Diabetes Self Care Behaviors and 12 months(Baseline, 12 months)
- Change from Baseline Diabetes Quality of Life and 12 months(Baseline, 12 months)
研究者
Weiping Jia
Professor, Director of Shanghai Diabetes Institute
Shanghai 6th People's Hospital