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

NCT ID: NCT03958838

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-30

Study Completion Date

2021-11-03

Brief Summary

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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

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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

Conditions

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Type2 Diabetes PreDiabetes

Keywords

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Peer Support Social Support Primary Care Integrated Care Community-Based Self-Management Diabetes Care

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Intervention group and Control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Peer Support Integrated with Primary Care

Intervention Type BEHAVIORAL

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.

Control Group

Subjects in the control group will receive usual care from community health center staff.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Merck Foundation

UNKNOWN

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weiping Jia

Professor, Director of Shanghai Diabetes Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Weiping Jia, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 6th People's Hospital

Edwin B Fisher, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

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Anting Huangdu Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Baihe Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Dachang Qilian Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Fangsong Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Guangzhong Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Huamu Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Liantang Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Luodian Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Nanxiang Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Nicheng Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Ouyang Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Waigang Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Xiao Kunshan Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Xuhang Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Yichuan Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Zhaoxiang Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 22232103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26304972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24781960 (View on PubMed)

Evans M, Liu Y, Wu X, Cai C, Tang PY, Maggy Coufal M, Qian Y, Fisher EB, Jia W. Community organization guides standardization, adaptability, and innovation: lessons from peer support in the Shanghai Integration Model. Transl Behav Med. 2023 Aug 11;13(8):519-532. doi: 10.1093/tbm/ibac094.

Reference Type DERIVED
PMID: 37406180 (View on PubMed)

Other Identifiers

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2019-028

Identifier Type: -

Identifier Source: org_study_id