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

Primary Purpose

Type2 Diabetes, PreDiabetes

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Peer Support Integrated with Primary Care
Sponsored by
Shanghai 6th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes focused on measuring Peer Support, Social Support, Primary Care, Integrated Care, Community-Based, Self-Management, Diabetes Care

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Anting Huangdu Community Health Center
  • Baihe Community Health Center
  • Dachang Qilian Community Health Center
  • Fangsong Community Health Center
  • Guangzhong Community Health Center
  • Huamu Community Health Center
  • Liantang Community Health Center
  • Luodian Community Health Center
  • Nanxiang Community Health Center
  • Nicheng Community Health Center
  • Ouyang Community Health Center
  • Waigang Community Health Center
  • Xiao Kunshan Community Health Center
  • Xuhang Community Health Center
  • Yichuan Community Health Center
  • Zhaoxiang Community Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline Fasting Blood Glucose and at 12 months
FPG (mmol/L)
Change from Baseline Blood Pressure and at 12 months
SBP and DBP (mmHg)
Change from Baseline BMI and at 12 months
Height (cm) and weight (kg)
Change from Baseline Blood Lipids and at 12 months
Total cholesterol, triglycerides, HDL, LDL (mmol/L)
Change from Baseline Waist circumference and at 12 months
Waist circumference (cm)
Change from Baseline Hemoglobin and at 12 months
Hemoglobin (g/L)
Change from Baseline Red Blood Cell Count and at 12 months
Red blood cell count (10^12/L)
Change from Baseline Mean Corpuscular Volume and at 12 months
Mean Corpuscular Volume (fL)
Change from Baseline Mean Corpuscular Hemoglobin and at 12 months
Mean Corpuscular Hemoglobin (pg)
Change from Baseline Liver Functioning and at 12 months
ALT (U/L), AST (U/L), Alkaline phosphatase (U/L), r-GT (U/L)
Change from Baseline Bilirubin and at 12 months
Total bilirubin (μmol/L), Direct bilirubin (μmol/L)
Change from Baseline Blood Urea and at 12 months
Blood urea (mmol/L)
Change from Baseline Serum Creatinine and at 12 months
Serum creatinine (μmol/L)
Change from Baseline Uric Acid and at 12 months
Uric acid (μmol/L)
Change from Baseline Urine Albumin/Creatinine Ratio and at 12 months
Albumin (mg/L), Creatinine (mmol/L)
Change in Insulin Functioning at 6 and 12 months
Insulin (pmol/L)
Change in C-peptides at 6 and 12 months
C-peptide (nmol/L)
Change in CRP at 6 and 12 months
CRP (mg/dL)
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.
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"
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.
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.
Change from Baseline Insulin Attitudes and 12 months
ITAS items, 6 questions
Change in Neighborhood Interactions and 12 months
6 questions
Change in Peer Support Engagement and Health Care Utilization and 12 months
5 questions

Full Information

First Posted
May 20, 2019
Last Updated
May 4, 2022
Sponsor
Shanghai 6th People's Hospital
Collaborators
University of North Carolina, Chapel Hill, Merck Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03958838
Brief Title
Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Dissemination To 12 Communities
Official Title
Peer Support to Enhance the Shanghai Integration Model of Diabetes Care: Dissemination to 12 Communities
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital
Collaborators
University of North Carolina, Chapel Hill, Merck Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes, PreDiabetes
Keywords
Peer Support, Social Support, Primary Care, Integrated Care, Community-Based, Self-Management, Diabetes Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention group and Control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects in the control group will receive usual care from community health center staff.
Intervention Type
Behavioral
Intervention Name(s)
Peer Support Integrated with Primary Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline HbA1c and at 12 months
Description
HbA1c (%)
Time Frame
Baseline, 12 months
Secondary Outcome Measure Information:
Title
Change from Baseline Fasting Blood Glucose and at 12 months
Description
FPG (mmol/L)
Time Frame
Baseline, 12 months
Title
Change from Baseline Blood Pressure and at 12 months
Description
SBP and DBP (mmHg)
Time Frame
Baseline, 12 months
Title
Change from Baseline BMI and at 12 months
Description
Height (cm) and weight (kg)
Time Frame
Baseline, 12 months
Title
Change from Baseline Blood Lipids and at 12 months
Description
Total cholesterol, triglycerides, HDL, LDL (mmol/L)
Time Frame
Baseline, 12 months
Title
Change from Baseline Waist circumference and at 12 months
Description
Waist circumference (cm)
Time Frame
Baseline, 12 months
Title
Change from Baseline Hemoglobin and at 12 months
Description
Hemoglobin (g/L)
Time Frame
Baseline, 12 months
Title
Change from Baseline Red Blood Cell Count and at 12 months
Description
Red blood cell count (10^12/L)
Time Frame
Baseline, 12 months
Title
Change from Baseline Mean Corpuscular Volume and at 12 months
Description
Mean Corpuscular Volume (fL)
Time Frame
Baseline, 12 months
Title
Change from Baseline Mean Corpuscular Hemoglobin and at 12 months
Description
Mean Corpuscular Hemoglobin (pg)
Time Frame
Baseline, 12 months
Title
Change from Baseline Liver Functioning and at 12 months
Description
ALT (U/L), AST (U/L), Alkaline phosphatase (U/L), r-GT (U/L)
Time Frame
Baseline, 12 months
Title
Change from Baseline Bilirubin and at 12 months
Description
Total bilirubin (μmol/L), Direct bilirubin (μmol/L)
Time Frame
Baseline, 12 months
Title
Change from Baseline Blood Urea and at 12 months
Description
Blood urea (mmol/L)
Time Frame
Baseline, 12 months
Title
Change from Baseline Serum Creatinine and at 12 months
Description
Serum creatinine (μmol/L)
Time Frame
Baseline, 12 months
Title
Change from Baseline Uric Acid and at 12 months
Description
Uric acid (μmol/L)
Time Frame
Baseline, 12 months
Title
Change from Baseline Urine Albumin/Creatinine Ratio and at 12 months
Description
Albumin (mg/L), Creatinine (mmol/L)
Time Frame
Baseline, 12 months
Title
Change in Insulin Functioning at 6 and 12 months
Description
Insulin (pmol/L)
Time Frame
Baseline, 12 months
Title
Change in C-peptides at 6 and 12 months
Description
C-peptide (nmol/L)
Time Frame
Baseline, 12 months
Title
Change in CRP at 6 and 12 months
Description
CRP (mg/dL)
Time Frame
Baseline, 12 months
Title
Change from Baseline Diabetes Self Care Behaviors and 12 months
Description
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.
Time Frame
Baseline, 12 months
Title
Change from Baseline General Quality of Life and 12 months
Description
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"
Time Frame
Baseline, 12 months
Title
Change from Baseline Diabetes Quality of Life and 12 months
Description
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.
Time Frame
Baseline, 12 months
Title
Change from Baseline Depression and 12 months
Description
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.
Time Frame
Baseline, 12 months
Title
Change from Baseline Insulin Attitudes and 12 months
Description
ITAS items, 6 questions
Time Frame
Baseline, 12 months
Title
Change in Neighborhood Interactions and 12 months
Description
6 questions
Time Frame
Baseline, 12 months
Title
Change in Peer Support Engagement and Health Care Utilization and 12 months
Description
5 questions
Time Frame
Baseline, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiping Jia, MD, PhD
Organizational Affiliation
Shanghai 6th People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edwin B Fisher, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anting Huangdu Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Baihe Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Dachang Qilian Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Fangsong Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Guangzhong Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Huamu Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Liantang Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Luodian Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Nanxiang Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Nicheng Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Ouyang Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Waigang Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Xiao Kunshan Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Xuhang Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Yichuan Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Zhaoxiang Community Health Center
City
Shanghai
State/Province
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22232103
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.
Results Reference
background
PubMed Identifier
26304972
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.
Results Reference
background
PubMed Identifier
24781960
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.
Results Reference
background

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

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