Clinical trial NCT03437525: Peer Support in Diabetes Management - Insulin Peer Support
Official title: Peer Support in Diabetes Management - Insulin Peer Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: Diabetes
Self-Management
Primary Care
Community Health Center
Peer Support
Group Support
Integrated Care
Insulin
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
name: Sanofi
First posted: 2018-02-19
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Change from Baseline HbA1c at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Change from Baseline Fasting Blood Glucose at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Blood Pressure at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline BMI at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Blood Lipids at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Hemoglobin at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Red Blood Cell Count at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Mean Corpuscular Volume at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Mean Corpuscular Hemoglobin at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Liver Functioning at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Bilirubin at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Blood Urea at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Serum Creatinine at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Uric Acid at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Urine Albumin/Creatinine Ratio at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change in Insulin Functioning at 6 and 12 months
timeFrame: 6 months, 12 months
measure: Change in C-peptides at 6 and 12 months
timeFrame: 6 months, 12 months
measure: Change from Baseline Diabetes Self Care Behaviors at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Medication Adherence at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline General Quality of Life at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Diabetes Quality of Life at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change from Baseline Depression at 6 and 12 months
timeFrame: Baseline, 6 months, 12 months
measure: Change in Community Support for Diabetes at 6 and 12 months
timeFrame: 6 months, 12 months
measure: Change in Healthcare Utilization at 6 and 12 months
timeFrame: 6 months, 12 months
measure: Change from Baseline Insulin Attitudes at 6 and 12 months
timeFrame: Baseline, 6 months, 12 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 He Jing 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.