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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| Asian Center for Health Education | OTHER |
| Shanghai Municipal Commission of Health and Family Planning | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer Support Intervention | Experimental | 9 CHCs will receive the peer support intervention for the full duration of the study period (12 months). Baseline assessment, 12-month and 18-month evaluation to assess the effectiveness and sustainability of the intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peer Support | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline HbA1c at 12 and 18 months | HbA1c (%) | Baseline, 12 months, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Blood Pressure at 12 and 18 months | SBP and DBP (mmHg) | Baseline, 12 months, 18 months |
| Change from Baseline Blood Lipids at 12 and 18 months | LDL (mmol/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiping Jia, MD, PhD | Shanghai 6th People's Hospital | Principal Investigator |
| Edwin B Fisher, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China | ||
| An Ting Community Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22232103 | Background | 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. | |
| 26304972 | Background | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Original Design: This study uses a stepped wedge design in three successive cohorts. Ten community health centers (CHC) will be randomized to one of three cohorts, 3 CHCs in the first cohort vs. 3 CHCs in the second cohort vs. 4 CHCs in the third cohort.
Actual Implementation: The Peer Leader program was designed as an implementation study to assess the feasibility, effectiveness and sustainability of integrating peer support with routine care in CHCs. 10 CHCs were selected in this community-based prospective cohort study according to their having in place the key organizational resources and willingness to collaborate. However, one CHC withdrew due to its administrator's judgement of insufficient staff resources for implementation, resulting in 9 CHCs. A planned, stepped wedge design to stagger introduction of the program over subsets of CHCs proved impractical within the realities of those sites. Finally, 9 CHCs participated in this study as one single interventional group.
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| Baseline, 12 months, 18 months |
| 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 |
| 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 |
| 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 |
| Shanghai |
| Shanghai Municipality |
| China |
| Cao Yang Community Health Center | Shanghai | Shanghai Municipality | China |
| Hong Mei Community Health Center | Shanghai | Shanghai Municipality | China |
| Kang Jian Community Health Center | Shanghai | Shanghai Municipality | China |
| Long Hua Community Health Center | Shanghai | Shanghai Municipality | China |
| Nan Jing Xi Road Community Health Center | Shanghai | Shanghai Municipality | China |
| Tao Pu Community Health Center | Shanghai | Shanghai Municipality | China |
| Tian Lin Community Health Center | Shanghai | Shanghai Municipality | China |
| Zhen Ru Community Health Center | Shanghai | Shanghai Municipality | China |
| 24781960 | Background | 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. |