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 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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,160
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.
Anting Huangdu Community Health Center
Shanghai, Shanghai Municipality, China
Baihe Community Health Center
Shanghai, Shanghai Municipality, China
Dachang Qilian Community Health Center
Shanghai, Shanghai Municipality, China
Fangsong Community Health Center
Shanghai, Shanghai Municipality, China
Guangzhong Community Health Center
Shanghai, Shanghai Municipality, China
Huamu Community Health Center
Shanghai, Shanghai Municipality, China
Liantang Community Health Center
Shanghai, Shanghai Municipality, China
Luodian Community Health Center
Shanghai, Shanghai Municipality, China
Nanxiang Community Health Center
Shanghai, Shanghai Municipality, China
Nicheng Community Health Center
Shanghai, Shanghai Municipality, China
...and 6 more locations
Change from Baseline HbA1c and at 12 months
HbA1c (%)
Time frame: Baseline, 12 months
Change from Baseline Fasting Blood Glucose and at 12 months
FPG (mmol/L)
Time frame: Baseline, 12 months
Change from Baseline Blood Pressure and at 12 months
SBP and DBP (mmHg)
Time frame: Baseline, 12 months
Change from Baseline BMI and at 12 months
Height (cm) and weight (kg)
Time frame: Baseline, 12 months
Change from Baseline Blood Lipids and at 12 months
Total cholesterol, triglycerides, HDL, LDL (mmol/L)
Time frame: Baseline, 12 months
Change from Baseline Waist circumference and at 12 months
Waist circumference (cm)
Time frame: Baseline, 12 months
Change from Baseline Hemoglobin and at 12 months
Hemoglobin (g/L)
Time frame: Baseline, 12 months
Change from Baseline Red Blood Cell Count and at 12 months
Red blood cell count (10\^12/L)
Time frame: Baseline, 12 months
Change from Baseline Mean Corpuscular Volume and at 12 months
Mean Corpuscular Volume (fL)
Time frame: Baseline, 12 months
Change from Baseline Mean Corpuscular Hemoglobin and at 12 months
Mean Corpuscular Hemoglobin (pg)
Time frame: Baseline, 12 months
Change from Baseline Liver Functioning and at 12 months
ALT (U/L), AST (U/L), Alkaline phosphatase (U/L), r-GT (U/L)
Time frame: Baseline, 12 months
Change from Baseline Bilirubin and at 12 months
Total bilirubin (μmol/L), Direct bilirubin (μmol/L)
Time frame: Baseline, 12 months
Change from Baseline Blood Urea and at 12 months
Blood urea (mmol/L)
Time frame: Baseline, 12 months
Change from Baseline Serum Creatinine and at 12 months
Serum creatinine (μmol/L)
Time frame: Baseline, 12 months
Change from Baseline Uric Acid and at 12 months
Uric acid (μmol/L)
Time frame: Baseline, 12 months
Change from Baseline Urine Albumin/Creatinine Ratio and at 12 months
Albumin (mg/L), Creatinine (mmol/L)
Time frame: Baseline, 12 months
Change in Insulin Functioning at 6 and 12 months
Insulin (pmol/L)
Time frame: Baseline, 12 months
Change in C-peptides at 6 and 12 months
C-peptide (nmol/L)
Time frame: Baseline, 12 months
Change in CRP at 6 and 12 months
CRP (mg/dL)
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
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"
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
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.
Time frame: Baseline, 12 months
Change from Baseline Insulin Attitudes and 12 months
ITAS items, 6 questions
Time frame: Baseline, 12 months
Change in Neighborhood Interactions and 12 months
6 questions
Time frame: Baseline, 12 months
Change in Peer Support Engagement and Health Care Utilization and 12 months
5 questions
Time frame: Baseline, 12 months
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