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Clinical Trials/NCT03437525
NCT03437525
Completed
Not Applicable

Peer Support in Diabetes Management - Insulin Peer Support

Shanghai 6th People's Hospital11 sites in 1 country360 target enrollmentMarch 8, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Treated With Insulin
Sponsor
Shanghai 6th People's Hospital
Enrollment
360
Locations
11
Primary Endpoint
Change from Baseline HbA1c at 6 and 12 months
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed 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. 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.

Registry
clinicaltrials.gov
Start Date
March 8, 2017
End Date
December 31, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Weiping Jia

Professor, President of Shanghai 6th People's Hospital, Director of Shanghai Institute of Diabetes

Shanghai 6th People's Hospital

Eligibility Criteria

Inclusion Criteria

  • Has type 2 diabetes
  • Receiving treatment at participating community health center
  • Currently using insulin or prescribed insulin but not currently using insulin

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change from Baseline HbA1c at 6 and 12 months

Time Frame: Baseline, 6 months, 12 months

HbA1c (%)

Secondary Outcomes

  • 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)

Study Sites (11)

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