Peer Support in Diabetes Management - Insulin Peer Support

NCT ID: NCT03437525

Last Updated: 2019-05-22

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

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

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.

Conditions

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Type 2 Diabetes Treated With Insulin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a cluster randomized controlled trial design with one experimental condition and one control condition. Ten community health centers (CHC) will be randomized to either the experimental or control condition. The five CHCs in the experimental group will deliver the peer support intervention for 12 months and the five CHCs in the control group will deliver usual care.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Peer Support Intervention

The experimental group will receive the peer support intervention for 12 months.

Group Type EXPERIMENTAL

Peer Support

Intervention Type BEHAVIORAL

The intervention involves monthly education/support groups co-led by a CHC doctor / nurse and peer coaches. These meetings will begin with a general discussion about participants' previous month, what they had been doing, any special events etc. Meetings will devote time to identifying goals and specific plans for reaching them, rehearsal and/or discussion of specific behaviors to execute plans and ways in which the group members can be helpful to each other. This will be organized around a Diabetes Action Plan. Peer coaches will provide education and support for insulin therapy to help reduce barriers around insulin use. Peer coaches will also organize activities to promote healthy lifestyles, such as walking groups, to promote informal contacts among peer supporters and participants.

Control

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Peer Support

The intervention involves monthly education/support groups co-led by a CHC doctor / nurse and peer coaches. These meetings will begin with a general discussion about participants' previous month, what they had been doing, any special events etc. Meetings will devote time to identifying goals and specific plans for reaching them, rehearsal and/or discussion of specific behaviors to execute plans and ways in which the group members can be helpful to each other. This will be organized around a Diabetes Action Plan. Peer coaches will provide education and support for insulin therapy to help reduce barriers around insulin use. Peer coaches will also organize activities to promote healthy lifestyles, such as walking groups, to promote informal contacts among peer supporters and participants.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Chinese
* 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.)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

Asian Center for Health Education

OTHER

Sponsor Role collaborator

Shanghai Municipal Commission of Health and Family Planning

OTHER

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

Shanghai 6th People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Weiping Jia

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

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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Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

An Ting Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Cao He Jing Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Cao Yang Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Hong Mei Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Kang Jian Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Long Hua Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Nan Jing Xi Road Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Tao Pu Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Tian Lin Community Health Center

Shanghai, Shanghai Municipality, China

Site Status

Zhen Ru 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)

Other Identifiers

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2017-73

Identifier Type: -

Identifier Source: org_study_id

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