Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Extension & Dissemination

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Extension & Dissemination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03438617
• Other study ID #: 2017-197
• Status: Completed
• Phase: N/A
• Start date: March 8, 2017
• Est. completion date: February 11, 2019

Study information

• Verified date: January 2023
• Source: Shanghai 6th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1284
• Est. completion date: February 11, 2019
• Est. primary completion date: February 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• Peer Support
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.

Locations

Country	Name	City	State
China	An Ting Community Health Center	Shanghai	Shanghai
China	Cao Yang Community Health Center	Shanghai	Shanghai
China	Hong Mei Community Health Center	Shanghai	Shanghai
China	Kang Jian Community Health Center	Shanghai	Shanghai
China	Long Hua Community Health Center	Shanghai	Shanghai
China	Nan Jing Xi Road Community Health Center	Shanghai	Shanghai
China	Shanghai Sixth People's Hospital	Shanghai	Shanghai
China	Tao Pu Community Health Center	Shanghai	Shanghai
China	Tian Lin Community Health Center	Shanghai	Shanghai
China	Zhen Ru Community Health Center	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital	Asian Center for Health Education, Shanghai Municipal Commission of Health and Family Planning, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline HbA1c at 12 and 18 months	HbA1c (%)	Baseline, 12 months, 18 months
Secondary	Change from Baseline Blood Pressure at 12 and 18 months	SBP and DBP (mmHg)	Baseline, 12 months, 18 months
Secondary	Change from Baseline Blood Lipids at 12 and 18 months	LDL (mmol/L)	Baseline, 12 months, 18 months
Secondary	Change from Baseline General Quality of Life at 12 and 18 months	5-item measure of quality of life adapted from the EQ-5D, a standardized instrument for measuring generic health status. The respondents are asked to choose one of the statements which best describes their health status on the surveyed day. Rated level can be coded as a number 1, 2, or 3, which indicates having no problems for 1, having some problems for 2, and having extreme problems for 3. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 33333 (having extreme problems in all dimensions). A sixth item, the visual analogue scale, was not included.	Baseline, 12 months, 18 months
Secondary	Change from Baseline Diabetes Distress at 12 and 18 months	4-item measure of diabetes distress adapted from the 17-item Diabetes Distress Scale. The respondents are asked to respond to which degree each of the items has bothered them in the past month on a 6-point scale (1-6), where 1 is not a brother and 6 is very bothersome. Scores are summed and divided by 4 to calculate the mean.	Baseline, 12 months, 18 months
Secondary	Change from Baseline Depression at 12 and 18 months	8-item Patient Health Questionnaire (PHQ), the PHQ-9 minus the last question on suicidal thoughts. The PHQ is a standard instrument used in primary care settings to screen for the presence and severity of depression. The respondents are asked how often they have been bothered by each of the 8 items in the past 2 weeks on a 4 point scale (0-3), where 0 is "not all" and 3 is "nearly every day". The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.	Baseline, 12 months, 18 months