Peer Support To Enhance The Shanghai Integration Model Of Diabetes Care: Dissemination To 12 Communities
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| ClinicalTrials.gov Identifier: NCT03958838 |
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Recruitment Status :
Active, not recruiting
First Posted : May 22, 2019
Last Update Posted : September 27, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Type2 Diabetes PreDiabetes | Behavioral: Peer Support Integrated with Primary Care | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2160 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Intervention group and Control group |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Peer Support to Enhance the Shanghai Integration Model of Diabetes Care: Dissemination to 12 Communities |
| Actual Study Start Date : | May 25, 2019 |
| Estimated Primary Completion Date : | December 31, 2021 |
| Estimated Study Completion Date : | December 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Intervention Group
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. |
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. |
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No Intervention: Control Group
Subjects in the control group will receive usual care from community health center staff.
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- Change from Baseline HbA1c and at 12 months [ Time Frame: Baseline, 12 months ]HbA1c (%)
- Change from Baseline Fasting Blood Glucose and at 12 months [ Time Frame: Baseline, 12 months ]FPG (mmol/L)
- Change from Baseline Blood Pressure and at 12 months [ Time Frame: Baseline, 12 months ]SBP and DBP (mmHg)
- Change from Baseline BMI and at 12 months [ Time Frame: Baseline, 12 months ]Height (cm) and weight (kg)
- Change from Baseline Blood Lipids and at 12 months [ Time Frame: Baseline, 12 months ]Total cholesterol, triglycerides, HDL, LDL (mmol/L)
- Change from Baseline Waist circumference and at 12 months [ Time Frame: Baseline, 12 months ]Waist circumference (cm)
- Change from Baseline Hemoglobin and at 12 months [ Time Frame: Baseline, 12 months ]Hemoglobin (g/L)
- Change from Baseline Red Blood Cell Count and at 12 months [ Time Frame: Baseline, 12 months ]Red blood cell count (10^12/L)
- Change from Baseline Mean Corpuscular Volume and at 12 months [ Time Frame: Baseline, 12 months ]Mean Corpuscular Volume (fL)
- Change from Baseline Mean Corpuscular Hemoglobin and at 12 months [ Time Frame: Baseline, 12 months ]Mean Corpuscular Hemoglobin (pg)
- Change from Baseline Liver Functioning and at 12 months [ Time Frame: Baseline, 12 months ]ALT (U/L), AST (U/L), Alkaline phosphatase (U/L), r-GT (U/L)
- Change from Baseline Bilirubin and at 12 months [ Time Frame: Baseline, 12 months ]Total bilirubin (μmol/L), Direct bilirubin (μmol/L)
- Change from Baseline Blood Urea and at 12 months [ Time Frame: Baseline, 12 months ]Blood urea (mmol/L)
- Change from Baseline Serum Creatinine and at 12 months [ Time Frame: Baseline, 12 months ]Serum creatinine (μmol/L)
- Change from Baseline Uric Acid and at 12 months [ Time Frame: Baseline, 12 months ]Uric acid (μmol/L)
- Change from Baseline Urine Albumin/Creatinine Ratio and at 12 months [ Time Frame: Baseline, 12 months ]Albumin (mg/L), Creatinine (mmol/L)
- Change in Insulin Functioning at 6 and 12 months [ Time Frame: Baseline, 12 months ]Insulin (pmol/L)
- Change in C-peptides at 6 and 12 months [ Time Frame: Baseline, 12 months ]C-peptide (nmol/L)
- Change in CRP at 6 and 12 months [ Time Frame: Baseline, 12 months ]CRP (mg/dL）
- Change from Baseline Diabetes Self Care Behaviors and 12 months [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 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 [ Time Frame: Baseline, 12 months ]ITAS items, 6 questions
- Change in Neighborhood Interactions and 12 months [ Time Frame: Baseline, 12 months ]6 questions
- Change in Peer Support Engagement and Health Care Utilization and 12 months [ Time Frame: Baseline, 12 months ]5 questions
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adults age ≥ 18
- Chinese
- Has type 2 diabetes or prediabetes
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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)
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~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)
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~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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958838
| China, Shanghai | |
| 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, China | |
| Principal Investigator: | Weiping Jia, MD, PhD | Shanghai 6th People's Hospital | |
| Principal Investigator: | Edwin B Fisher, PhD | University of North Carolina, Chapel Hill |
| Responsible Party: | Weiping Jia, Professor, Director of Shanghai Diabetes Institute, Shanghai 6th People's Hospital |
| ClinicalTrials.gov Identifier: | NCT03958838 |
| Other Study ID Numbers: |
2019-028 |
| First Posted: | May 22, 2019 Key Record Dates |
| Last Update Posted: | September 27, 2021 |
| Last Verified: | September 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Peer Support Social Support Primary Care Integrated Care |
Community-Based Self-Management Diabetes Care |
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Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |