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

Type 2 Diabetes Mellitus Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

• NCT number: NCT03438617
• Study type: Interventional
• Source: Shanghai 6th People's Hospital
• Status: Completed
• Phase: N/A
• Start date: March 8, 2017
• Completion date: February 11, 2019