NCT03438617

Brief Summary

This project developed a combined model of the Shanghai Integration Model and peer support for diabetes self-management education and support. The program was implemented and evaluated in nine Community Health Centers in Shanghai, China. Note: This registration reflects modifications to a study that was registered in 2018.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,284

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 24, 2018

Last Update Submit

January 23, 2023

Conditions

Type 2 Diabetes Mellitus

Keywords

DiabetesSelf-ManagementPrimary CareCommunity Health CenterPeer SupportGroup SupportIntegrated CareChinaUrban

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline HbA1c at 12 and 18 months

    HbA1c (%)

    Baseline, 12 months, 18 months

Secondary Outcomes (5)

  • Change from Baseline Blood Pressure at 12 and 18 months

    Baseline, 12 months, 18 months

  • Change from Baseline Blood Lipids at 12 and 18 months

    Baseline, 12 months, 18 months

  • Change from Baseline General Quality of Life at 12 and 18 months

    Baseline, 12 months, 18 months

  • Change from Baseline Diabetes Distress at 12 and 18 months

    Baseline, 12 months, 18 months

  • Change from Baseline Depression at 12 and 18 months

    Baseline, 12 months, 18 months

Study Arms (1)

Peer Support Intervention

EXPERIMENTAL

9 CHCs will receive the peer support intervention for the full duration of the study period (12 months). Baseline assessment, 12-month and 18-month evaluation to assess the effectiveness and sustainability of the intervention.

Behavioral: Peer Support

Interventions

Peer SupportBEHAVIORAL

The intervention involves monthly education/support groups co-led by a CHC doctor / nurse and peer leaders. 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 leaders will also organize activities to promote healthy lifestyles, such as walking groups, to promote informal contacts among peer leaders and participants.

Peer Support Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese
  • Has type 2 diabetes
  • Receiving treatment at participating community health center

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

An Ting Community Health Center

Shanghai, Shanghai Municipality, China

Location

Cao Yang Community Health Center

Shanghai, Shanghai Municipality, China

Location

Hong Mei Community Health Center

Shanghai, Shanghai Municipality, China

Location

Kang Jian Community Health Center

Shanghai, Shanghai Municipality, China

Location

Long Hua Community Health Center

Shanghai, Shanghai Municipality, China

Location

Nan Jing Xi Road Community Health Center

Shanghai, Shanghai Municipality, China

Location

Tao Pu Community Health Center

Shanghai, Shanghai Municipality, China

Location

Tian Lin Community Health Center

Shanghai, Shanghai Municipality, China

Location

Zhen Ru Community Health Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (3)

  • 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.

    PMID: 22232103BACKGROUND

  • 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.

    PMID: 26304972BACKGROUND

  • 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.

    PMID: 24781960BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Weiping Jia, MD, PhD

    Shanghai 6th People's Hospital

    PRINCIPAL INVESTIGATOR

  • Edwin B Fisher, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Original Design: This study uses a stepped wedge design in three successive cohorts. Ten community health centers (CHC) will be randomized to one of three cohorts, 3 CHCs in the first cohort vs. 3 CHCs in the second cohort vs. 4 CHCs in the third cohort. Actual Implementation: The Peer Leader program was designed as an implementation study to assess the feasibility, effectiveness and sustainability of integrating peer support with routine care in CHCs. 10 CHCs were selected in this community-based prospective cohort study according to their having in place the key organizational resources and willingness to collaborate. However, one CHC withdrew due to its administrator's judgement of insufficient staff resources for implementation, resulting in 9 CHCs. A planned, stepped wedge design to stagger introduction of the program over subsets of CHCs proved impractical within the realities of those sites. Finally, 9 CHCs participated in this study as one single interventional group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director of Shanghai Institute of Diabetes, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 20, 2018

Study Start

March 8, 2017

Primary Completion

February 11, 2019

Study Completion

February 11, 2019

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)