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临床试验/NCT03438617
NCT03438617已完成不适用

Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Extension & Dissemination

Shanghai 6th People's Hospital10 个研究点 分布在 1 个国家目标入组 1,284 人开始时间: 2017年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,284
试验地点
10
主要终点
Change from Baseline HbA1c at 12 and 18 months

研究概览

简要总结

This project developed a combined model of the Shanghai Integration Model and peer support for diabetes self-management education and support. The program was implemented and evaluated in nine Community Health Centers in Shanghai, China.

Note: This registration reflects modifications to a study that was registered in 2018.

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 developed a combined model of the Shanghai Integration Model and peer support for diabetes self-management education and support. The program was implemented and evaluated in nine Community Health Centers (CHCs) in Shanghai, China. The program is a collaboration among the Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, the Shanghai Diabetes Institute, the Shanghai Health Bureau, 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.

A planned, stepped wedge design to stagger introduction of the program over subsets of CHCs proved impractical within the realities of those sites. Therefore, the original study protocol was modified in the following ways:

  • Instead of staggering program implementation among 3 cohorts of CHCs, all participating CHCs implemented the program concurrently in a single-arm design.
  • A greater number of participants were enrolled than anticipated.
  • To reduce risk of Type 1 error, the number of secondary endpoints was reduced to those central to diabetes management - glycemia, blood pressure, and lipids, and, in the area of psychosocial factors, depression, diabetes distress, and general quality of life.
  • The original plan called for outcome measures to be collected at baseline, 3 months, 6 months, and 12 months according to the stepped wedge study design. Since the CHCs implemented the program in one cohort, the outcome measures were collected at baseline, 12 months, and 18 months in order to assess the long term benefits given the chronic, progressive nature of diabetes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • Has type 2 diabetes
  • Receiving treatment at participating community health center

排除标准

  • Severe mental illness (severe depression, schizophrenia, bipolar disorder, obsessive compulsive disorder, panic disorder, PTSD, borderline personality disorder, etc.)

结局指标

主要结局

Change from Baseline HbA1c at 12 and 18 months

时间窗: Baseline, 12 months, 18 months

HbA1c (%)

次要结局

  • Change from Baseline Blood Lipids at 12 and 18 months(Baseline, 12 months, 18 months)
  • Change from Baseline Diabetes Distress at 12 and 18 months(Baseline, 12 months, 18 months)
  • Change from Baseline Blood Pressure at 12 and 18 months(Baseline, 12 months, 18 months)
  • Change from Baseline Depression at 12 and 18 months(Baseline, 12 months, 18 months)
  • Change from Baseline General Quality of Life at 12 and 18 months(Baseline, 12 months, 18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Weiping Jia

Professor, Director of Shanghai Institute of Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai 6th People's Hospital

研究点 (10)

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