Clinical trial NCT03438617: Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Extension & Dissemination
Official title: Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Extension & Dissemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
Self-Management
Primary Care
Community Health Center
Peer Support
Group Support
Integrated Care
China
Urban
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Asian Center for Health Education
name: Shanghai Municipal Commission of Health and Family Planning
First posted: 2018-02-20
Enrollment: 1284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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 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 (CHCs) in Shanghai, China. The program is a collaboration among the Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, the Shanghai Diabetes Institute, the Shanghai Health Bureau, 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.

A planned, stepped wedge design to stagger introduction of the program over subsets of CHCs proved impractical within the realities of those sites. Therefore, the original study protocol was modified in the following ways:

* Instead of staggering program implementation among 3 cohorts of CHCs, all participating CHCs implemented the program concurrently in a single-arm design.
* A greater number of participants were enrolled than anticipated.
* To reduce risk of Type 1 error, the number of secondary endpoints was reduced to those central to diabetes management - glycemia, blood pressure, and lipids, and, in the area of psychosocial factors, depression, diabetes distress, and general quality of life.
* The original plan called for outcome measures to be collected at baseline, 3 months, 6 months, and 12 months according to the stepped wedge study design. Since the CHCs implemented the program in one cohort, the outcome measures were collected at baseline, 12 months, and 18 months in order to assess the long term benefits given the chronic, progressive nature of diabetes.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Change from Baseline HbA1c at 12 and 18 months
timeFrame: Baseline, 12 months, 18 months
Secondary outcomes:
measure: Change from Baseline Blood Pressure at 12 and 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from Baseline Blood Lipids at 12 and 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from Baseline General Quality of Life at 12 and 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from Baseline Diabetes Distress at 12 and 18 months
timeFrame: Baseline, 12 months, 18 months
measure: Change from Baseline Depression at 12 and 18 months
timeFrame: Baseline, 12 months, 18 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: An Ting Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Cao Yang Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Hong Mei Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Kang Jian Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Long Hua Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Nan Jing Xi Road Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Tao Pu Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Tian Lin Community Health Center
state: Shanghai
city: Shanghai
country: China
facility: Zhen Ru Community Health Center
state: Shanghai
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Weiping Jia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Edwin B Fisher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.