Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Dissemination To 12 Communities

Peer Support to Enhance the Shanghai Integration Model of Diabetes Care: Dissemination to 12 Communities

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.

Study Overview

• Status: Completed
• Conditions: PreDiabetes; Type2 Diabetes
• Intervention / Treatment: Behavioral: Peer Support Integrated with Primary Care

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.

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

• Study Type: Interventional
• Enrollment (Actual): 2160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Anting Huangdu Community Health Center
    • Shanghai, Shanghai, China
      • Baihe Community Health Center
    • Shanghai, Shanghai, China
      • Dachang Qilian Community Health Center
    • Shanghai, Shanghai, China
      • Fangsong Community Health Center
    • Shanghai, Shanghai, China
      • Guangzhong Community Health Center
    • Shanghai, Shanghai, China
      • Huamu Community Health Center
    • Shanghai, Shanghai, China
      • Liantang Community Health Center
    • Shanghai, Shanghai, China
      • Luodian Community Health Center
    • Shanghai, Shanghai, China
      • Nanxiang Community Health Center
    • Shanghai, Shanghai, China
      • Nicheng Community Health Center
    • Shanghai, Shanghai, China
      • Ouyang Community Health Center
    • Shanghai, Shanghai, China
      • Waigang Community Health Center
    • Shanghai, Shanghai, China
      • Xiao Kunshan Community Health Center
    • Shanghai, Shanghai, China
      • Xuhang Community Health Center
    • Shanghai, Shanghai, China
      • Yichuan Community Health Center
    • Shanghai, Shanghai, China
      • Zhaoxiang Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults age ≥ 18
• Chinese
• 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)

Exclusion Criteria:

- 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Peer Support Integrated with Primary Care; Peer leaders will deliver support that address the four key functions of peer support, providing 1) assistance in daily self-management, 2) linkages to clinical care and community resources, 3) social and emotional support, and 4) ongoing, flexible support over time.
No Intervention: Control Group; Subjects in the control group will receive usual care from community health center staff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline HbA1c and at 12 months	HbA1c (%)	Baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Fasting Blood Glucose and at 12 months	FPG (mmol/L)	Baseline, 12 months
Change from Baseline Blood Pressure and at 12 months	SBP and DBP (mmHg)	Baseline, 12 months
Change from Baseline BMI and at 12 months	Height (cm) and weight (kg)	Baseline, 12 months
Change from Baseline Blood Lipids and at 12 months	Total cholesterol, triglycerides, HDL, LDL (mmol/L)	Baseline, 12 months
Change from Baseline Waist circumference and at 12 months	Waist circumference (cm)	Baseline, 12 months
Change from Baseline Hemoglobin and at 12 months	Hemoglobin (g/L)	Baseline, 12 months
Change from Baseline Red Blood Cell Count and at 12 months	Red blood cell count (10^12/L)	Baseline, 12 months
Change from Baseline Mean Corpuscular Volume and at 12 months	Mean Corpuscular Volume (fL)	Baseline, 12 months
Change from Baseline Mean Corpuscular Hemoglobin and at 12 months	Mean Corpuscular Hemoglobin (pg)	Baseline, 12 months
Change from Baseline Liver Functioning and at 12 months	ALT (U/L), AST (U/L), Alkaline phosphatase (U/L), r-GT (U/L)	Baseline, 12 months
Change from Baseline Bilirubin and at 12 months	Total bilirubin (μmol/L), Direct bilirubin (μmol/L)	Baseline, 12 months
Change from Baseline Blood Urea and at 12 months	Blood urea (mmol/L)	Baseline, 12 months
Change from Baseline Serum Creatinine and at 12 months	Serum creatinine (μmol/L)	Baseline, 12 months
Change from Baseline Uric Acid and at 12 months	Uric acid (μmol/L)	Baseline, 12 months
Change from Baseline Urine Albumin/Creatinine Ratio and at 12 months	Albumin (mg/L), Creatinine (mmol/L)	Baseline, 12 months
Change in Insulin Functioning at 6 and 12 months	Insulin (pmol/L)	Baseline, 12 months
Change in C-peptides at 6 and 12 months	C-peptide (nmol/L)	Baseline, 12 months
Change in CRP at 6 and 12 months	CRP (mg/dL）	Baseline, 12 months
Change from Baseline Diabetes Self Care Behaviors and 12 months	9 items from Summary of Diabetes Self Care Activities and Behavioral Risk Factor Surveillance System. Items 1-7 measure diabetes self care activities during the previous 7 days. Items 1, 2, 4-7 are assessed on a scale of 0 to 7 days. Item 3 is assessed on scale of 1-4, where 1 represents very low levels of daily activity and 4 represents very high levels of daily activity. Items 8 and 9 are yes/no questions that measure cigarette intake over the past 7 and 30 days.	Baseline, 12 months
Change from Baseline General Quality of Life and 12 months	6-item EQ-5D, a standardized instrument for measuring generic health status. The respondents are asked to choose one of the statements which best describes their health status on the surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). Item 6 is the visual analogue scale, in which respondents are asked to mark their health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100, where 0 corresponds to "the worst health you can imagine", and 100 corresponds to "the best health you can imagine"	Baseline, 12 months
Change from Baseline Diabetes Quality of Life and 12 months	4-item Diabetes Distress Scale, an abbreviated version of the 17-item Diabetes Distress Scale. The respondents are asked to respond to which degree each of the items has bothered them in the past month on a 6-point scale (1-6), where 1 is not a brother and 6 is very bothersome. Scores are summed and divided by 4 to calculate the mean. Mean scores of 3 or higher (moderate distress) are considered worthy of clinical attention.	Baseline, 12 months
Change from Baseline Depression and 12 months	8-item Patient Health Questionnaire (PHQ), the PHQ-9 minus the last question on suicidal thoughts. The PHQ is a standard instrument used in primary care settings to screen for the presence and severity of depression. The respondents are asked how often they have been bothered by each of the 8 items in the past 2 weeks on a 4 point scale (0-3), where 0 is "not all" and 3 is "nearly every day". The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.	Baseline, 12 months
Change from Baseline Insulin Attitudes and 12 months	ITAS items, 6 questions	Baseline, 12 months
Change in Neighborhood Interactions and 12 months	6 questions	Baseline, 12 months
Change in Peer Support Engagement and Health Care Utilization and 12 months	5 questions	Baseline, 12 months

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Collaborators: University of North Carolina, Chapel Hill; Merck Foundation
• Investigators: Principal Investigator: Weiping Jia, MD, PhD, Shanghai 6th People's Hospital; Principal Investigator: Edwin B Fisher, PhD, University of North Carolina, Chapel Hill

Publications and helpful links

General Publications

• Fisher EB, Boothroyd RI, Coufal MM, Baumann LC, Mbanya JC, Rotheram-Borus MJ, Sanguanprasit B, Tanasugarn C. Peer support for self-management of diabetes improved outcomes in international settings. Health Aff (Millwood). 2012 Jan;31(1):130-9. doi: 10.1377/hlthaff.2011.0914.
• Zhong X, Wang Z, Fisher EB, Tanasugarn C. Peer Support for Diabetes Management in Primary Care and Community Settings in Anhui Province, China. Ann Fam Med. 2015 Aug;13 Suppl 1(Suppl 1):S50-8. doi: 10.1370/afm.1799.
• Chan JC, Sui Y, Oldenburg B, Zhang Y, Chung HH, Goggins W, Au S, Brown N, Ozaki R, Wong RY, Ko GT, Fisher E; JADE and PEARL Project Team. Effects of telephone-based peer support in patients with type 2 diabetes mellitus receiving integrated care: a randomized clinical trial. JAMA Intern Med. 2014 Jun;174(6):972-81. doi: 10.1001/jamainternmed.2014.655.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 20, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Primary Care; Integrated Care; Self-Management; Social Support; Peer Support; Diabetes Care; Community-Based
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2019-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No