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.

Trial Health

On Track

Trial Health Score

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

Enrollment

2,160

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach

1 country

16 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

2.6 years study duration

Study Start

First participant enrolled

March 30, 2019

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2021

Completed

Last Updated

December 16, 2024

Status Verified

December 1, 2024

Enrollment Period

2.6 years

First QC Date

May 20, 2019

Last Update Submit

December 11, 2024

Conditions

Type2 Diabetes PreDiabetes

Keywords

Peer SupportSocial SupportPrimary CareIntegrated CareCommunity-BasedSelf-ManagementDiabetes Care

Outcome Measures

Primary Outcomes (1)

Change from Baseline HbA1c and at 12 months
HbA1c (%)
Baseline, 12 months

Secondary Outcomes (25)

Change from Baseline Fasting Blood Glucose and at 12 months
Baseline, 12 months
Change from Baseline Blood Pressure and at 12 months
Baseline, 12 months
Change from Baseline BMI and at 12 months
Baseline, 12 months
Change from Baseline Blood Lipids and at 12 months
Baseline, 12 months
Change from Baseline Waist circumference and at 12 months
Baseline, 12 months
+20 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Peer Support Integrated with Primary Care

Control Group

NO INTERVENTION

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

Interventions

Peer Support Integrated with Primary CareBEHAVIORAL

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 Group

Eligibility Criteria

Age18 Years - 99 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)
+2 more criteria

You may not qualify if:

\- 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)

Contact the study team to confirm eligibility.