Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Dissemination To 12 Communities

PreDiabetes Clinical Trial

Official title:

Peer Support to Enhance the Shanghai Integration Model of Diabetes Care: Dissemination to 12 Communities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958838
• Other study ID #: 2019-028
• Status: Completed
• Phase: N/A
• Start date: May 25, 2019
• Est. completion date: December 31, 2022

Study information

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

Clinical Trial 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.

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 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. The program is a collaboration among the Shanghai Sixth People's Hospital, Shanghai Jiao Tong University, the Shanghai Diabetes Institute, the National Office for Primary Diabetes Care, the Shanghai Municipal Health Commission, the Shanghai Municipal Center for Disease Control and Prevention, 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. Collaborators: Shanghai Sixth People's Hospital Shanghai Jiao Tong University Shanghai Diabetes Institute National Office for Primary Diabetes Care Shanghai Municipal Health Commission Shanghai Municipal Center for Disease Control and Prevention University of North Carolina at Chapel Hill, Peers for Progress

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2160
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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)
• ~40 patients (Diabetics with poor control, FPG=9.7 mmol/L)
• ~40 patients Newly-diagnosed diabetics within 2 years)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• PreDiabetes
• Type2 Diabetes

Intervention

Behavioral:
• Peer Support Integrated with Primary Care
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.

Locations

Country	Name	City	State
China	Anting Huangdu Community Health Center	Shanghai	Shanghai
China	Baihe Community Health Center	Shanghai	Shanghai
China	Dachang Qilian Community Health Center	Shanghai	Shanghai
China	Fangsong Community Health Center	Shanghai	Shanghai
China	Guangzhong Community Health Center	Shanghai	Shanghai
China	Huamu Community Health Center	Shanghai	Shanghai
China	Liantang Community Health Center	Shanghai	Shanghai
China	Luodian Community Health Center	Shanghai	Shanghai
China	Nanxiang Community Health Center	Shanghai	Shanghai
China	Nicheng Community Health Center	Shanghai	Shanghai
China	Ouyang Community Health Center	Shanghai	Shanghai
China	Waigang Community Health Center	Shanghai	Shanghai
China	Xiao Kunshan Community Health Center	Shanghai	Shanghai
China	Xuhang Community Health Center	Shanghai	Shanghai
China	Yichuan Community Health Center	Shanghai	Shanghai
China	Zhaoxiang Community Health Center	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital	Merck Foundation, 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 and at 12 months	HbA1c (%)	Baseline, 12 months
Secondary	Change from Baseline Fasting Blood Glucose and at 12 months	FPG (mmol/L)	Baseline, 12 months
Secondary	Change from Baseline Blood Pressure and at 12 months	SBP and DBP (mmHg)	Baseline, 12 months
Secondary	Change from Baseline BMI and at 12 months	Height (cm) and weight (kg)	Baseline, 12 months
Secondary	Change from Baseline Blood Lipids and at 12 months	Total cholesterol, triglycerides, HDL, LDL (mmol/L)	Baseline, 12 months
Secondary	Change from Baseline Waist circumference and at 12 months	Waist circumference (cm)	Baseline, 12 months
Secondary	Change from Baseline Hemoglobin and at 12 months	Hemoglobin (g/L)	Baseline, 12 months
Secondary	Change from Baseline Red Blood Cell Count and at 12 months	Red blood cell count (10^12/L)	Baseline, 12 months
Secondary	Change from Baseline Mean Corpuscular Volume and at 12 months	Mean Corpuscular Volume (fL)	Baseline, 12 months
Secondary	Change from Baseline Mean Corpuscular Hemoglobin and at 12 months	Mean Corpuscular Hemoglobin (pg)	Baseline, 12 months
Secondary	Change from Baseline Liver Functioning and at 12 months	ALT (U/L), AST (U/L), Alkaline phosphatase (U/L), r-GT (U/L)	Baseline, 12 months
Secondary	Change from Baseline Bilirubin and at 12 months	Total bilirubin (µmol/L), Direct bilirubin (µmol/L)	Baseline, 12 months
Secondary	Change from Baseline Blood Urea and at 12 months	Blood urea (mmol/L)	Baseline, 12 months
Secondary	Change from Baseline Serum Creatinine and at 12 months	Serum creatinine (µmol/L)	Baseline, 12 months
Secondary	Change from Baseline Uric Acid and at 12 months	Uric acid (µmol/L)	Baseline, 12 months
Secondary	Change from Baseline Urine Albumin/Creatinine Ratio and at 12 months	Albumin (mg/L), Creatinine (mmol/L)	Baseline, 12 months
Secondary	Change in Insulin Functioning at 6 and 12 months	Insulin (pmol/L)	Baseline, 12 months
Secondary	Change in C-peptides at 6 and 12 months	C-peptide (nmol/L)	Baseline, 12 months
Secondary	Change in CRP at 6 and 12 months	CRP (mg/dL)	Baseline, 12 months
Secondary	Change from Baseline Diabetes Self Care Behaviors and 12 months	9 items from Summary of Diabetes Self Care Activities and Behavioral Risk Factor Surveillance System. Items 1-7 measure diabetes self care activities during the previous 7 days. Items 1, 2, 4-7 are assessed on a scale of 0 to 7 days. Item 3 is assessed on scale of 1-4, where 1 represents very low levels of daily activity and 4 represents very high levels of daily activity. Items 8 and 9 are yes/no questions that measure cigarette intake over the past 7 and 30 days.	Baseline, 12 months
Secondary	Change from Baseline General Quality of Life and 12 months	6-item 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). Item 6 is the visual analogue scale, in which respondents are asked to mark their health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100, where 0 corresponds to "the worst health you can imagine", and 100 corresponds to "the best health you can imagine"	Baseline, 12 months
Secondary	Change from Baseline Diabetes Quality of Life and 12 months	4-item Diabetes Distress Scale, an abbreviated version of 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. Mean scores of 3 or higher (moderate distress) are considered worthy of clinical attention.	Baseline, 12 months
Secondary	Change from Baseline Depression and 12 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
Secondary	Change from Baseline Insulin Attitudes and 12 months	ITAS items, 6 questions	Baseline, 12 months
Secondary	Change in Neighborhood Interactions and 12 months	6 questions	Baseline, 12 months
Secondary	Change in Peer Support Engagement and Health Care Utilization and 12 months	5 questions	Baseline, 12 months