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| ID | Type | Description | Link |
|---|---|---|---|
| U54MD007584 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The investigators are conducting a feasibility study using a randomized controlled trial (RCT) design in which participants will receive the Partners in Care (PIC) diabetes self-management intervention and then be randomized to either semi-structured social support or a standard follow-up control group. Participants in the support groups will receive a culturally-tailored, semi-structured social support program delivered in a community setting by trained community peer educators and other health professionals (e.g., pharmacist). The investigators believe that the addition of a semi-structured social support component as a supplement to an evidence-based diabetes self-management intervention will improve diabetes self-care maintenance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partners in Care with Semi-Structured Support Group | Experimental | Partners in Care with Semi-Structured Support Group: participants will receive the Partners in Care intervention followed by 6 semi-structured support groups, conducted every other week for 3 months. Half of the support groups will be conducted by professionals with diabetes specific knowledge, e.g., pharmacists, physicians, nutritionists. While the other half will be conducted by the trained diabetes self-management facilitator. |
|
| Partners in Care Standard Follow-up | No Intervention | Participants will receive the Partners in Care intervention followed by monthly healthy lifestyle tips related to diabetes self-management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partners in Care with Semi-Structured Support Group | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline hemoglobin a1c at 3 months and at 6 months | baseline, 3 months, 6 months | |
| Change from Baseline diabetes management functioning as measured by the Problem Areas in Diabetes questionnaire at 3 months and 6 months | The PAID is a 20-item instrument that assesses the physical and social functioning of patients as well as their perceived level of mental and emotional well-being specific to living with diabetes. | baseline, 3 months, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline blood pressure at 3 months and 6 months | baseline, 3 months, 6 months | |
| Change from Baseline Total Cholesterol (including HDL and LDL) and triglycerides at 3 months and 6 months | Total Cholesterol (including HDL and LDL) and triglycerides will be measured with the Cholestech LDX analyzer |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline reported diabetes self-care activities as measured by the Summary of Diabetes Self-Care Activities questionnaire at 3 months and 6 months | baseline, 3 months, 6 months | |
| Change from Baseline reported amount of support as measured a questionnaire at 3 months and 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kula no na Po'e Hawai'i | Honolulu | Hawaii | 96813 | United States | ||
| Ke Ola Mamao |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23086589 | Background | Sinclair KA, Makahi EK, Shea-Solatorio C, Yoshimura SR, Townsend CK, Kaholokula JK. Outcomes from a diabetes self-management intervention for Native Hawaiians and Pacific People: Partners in Care. Ann Behav Med. 2013 Feb;45(1):24-32. doi: 10.1007/s12160-012-9422-1. | |
| 26703660 | Derived | Townsend CK, Dillard A, Hosoda KK, Maskarinec GG, Maunakea AK, Yoshimura SR, Hughes C, Palakiko DM, Kehauoha BP, Kaholokula JK. Community-Based Participatory Research Integrates Behavioral and Biological Research to Achieve Health Equity for Native Hawaiians. Int J Environ Res Public Health. 2015 Dec 22;13(1):ijerph13010004. doi: 10.3390/ijerph13010004. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| baseline, 3 months, 6 months |
| Change from Baseline weight in kg at 3 months and 6 months | baseline, 3 months, 6 months |
| baseline, 3 months, 6 months |
| Change from Baseline amount of physical activity as measured a questionnaire at 3 months and 6 months | baseline, 3 months, 6 months |
| Change from Baseline dietary patterns as a questionnaire at 3 months and 6 months | baseline, 3 months, 6 months |
| Honolulu |
| Hawaii |
| 96817 |
| United States |
| Kokua Kalihi Valley | Honolulu | Hawaii | 96819 | United States |
| D004700 | Endocrine System Diseases |