NCT03437525

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

11 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
26 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2019

Enrollment Period

1.8 years

First QC Date

January 24, 2018

Last Update Submit

May 20, 2019

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

DiabetesSelf-ManagementPrimary CareCommunity Health CenterPeer SupportGroup SupportIntegrated CareInsulinChinaUrban

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline HbA1c at 6 and 12 months

    HbA1c (%)

    Baseline, 6 months, 12 months

Secondary Outcomes (24)

  • Change from Baseline Fasting Blood Glucose at 6 and 12 months

    Baseline, 6 months, 12 months

  • Change from Baseline Blood Pressure at 6 and 12 months

    Baseline, 6 months, 12 months

  • Change from Baseline BMI at 6 and 12 months

    Baseline, 6 months, 12 months

  • Change from Baseline Blood Lipids at 6 and 12 months

    Baseline, 6 months, 12 months

  • Change from Baseline Hemoglobin at 6 and 12 months

    Baseline, 6 months, 12 months

  • +19 more secondary outcomes

Study Arms (2)

Peer Support Intervention

EXPERIMENTAL

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

Behavioral: Peer Support

Control

NO INTERVENTION

Usual care

Interventions

Peer SupportBEHAVIORAL

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.

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
  • Currently using insulin or prescribed insulin but not currently using insulin

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 (11)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200235, China

Location

An Ting Community Health Center

Shanghai, Shanghai Municipality, China

Location

Cao He Jing 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 MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

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
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, President of Shanghai 6th People's Hospital, Director of Shanghai Institute of Diabetes

Study Record Dates

First Submitted

January 24, 2018

First Posted

February 19, 2018

Study Start

March 8, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

May 22, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(11)