Clinical trial NCT03958838: Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Dissemination To 12 Communities
Official title: Peer Support to Enhance the Shanghai Integration Model of Diabetes Care: Dissemination to 12 Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
PreDiabetes
Keywords: Peer Support
Social Support
Primary Care
Integrated Care
Community-Based
Self-Management
Diabetes Care
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Merck Foundation
First posted: 2019-05-22
Enrollment: 2160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention group and Control group
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Change from Baseline HbA1c and at 12 months
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change from Baseline Fasting Blood Glucose and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Blood Pressure and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline BMI and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Blood Lipids and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Waist circumference and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Hemoglobin and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Red Blood Cell Count and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Mean Corpuscular Volume and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Mean Corpuscular Hemoglobin and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Liver Functioning and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Bilirubin and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Blood Urea and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Serum Creatinine and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Uric Acid and at 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Urine Albumin/Creatinine Ratio and at 12 months
timeFrame: Baseline, 12 months
measure: Change in Insulin Functioning at 6 and 12 months
timeFrame: Baseline, 12 months
measure: Change in C-peptides at 6 and 12 months
timeFrame: Baseline, 12 months
measure: Change in CRP at 6 and 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Diabetes Self Care Behaviors and 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline General Quality of Life and 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Diabetes Quality of Life and 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Depression and 12 months
timeFrame: Baseline, 12 months
measure: Change from Baseline Insulin Attitudes and 12 months
timeFrame: Baseline, 12 months
measure: Change in Neighborhood Interactions and 12 months
timeFrame: Baseline, 12 months
measure: Change in Peer Support Engagement and Health Care Utilization and 12 months
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Anting Huangdu Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Baihe Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Dachang Qilian Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Fangsong Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Guangzhong Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Huamu Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Liantang Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Luodian Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Nanxiang Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Nicheng Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Ouyang Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Waigang Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Xiao Kunshan Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Xuhang Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Yichuan Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Zhaoxiang Community Health Center
state: Shanghai
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Weiping Jia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Edwin B Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.