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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| South Carolina Department of Health and Human Services | UNKNOWN |
| North Carolina Translational and Clinical Sciences Institute | OTHER |
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Bamberg County residents who has been diagnosed with or is at high risk for diabetes, may be eligible for a clinical research study to improve diabetes self-management and decrease hospital re-admissions.
The purpose of this study is to compare the effectiveness of three hospital discharge follow-up methods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Survey assessments as well as collection of medical records and billing information. |
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| Telephonic Nurse Intervention | Active Comparator | Survey assessments as well as collection of medical records and billing information. A nurse will communicate with participants via telephone to support diabetes self-management practices. |
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| In-person Community Health Worker Intervention | Active Comparator | Survey assessments as well as collection of medical records and billing information. A community health worker will work with participants in person to support diabetes self-management practices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surveys | Behavioral | The following information will be collected: demographics, literacy screener, depression screener, medication adherence, self-efficacy, tobacco use, patient activation, health questionnaire, eating patterns, diabetes self-management assessment, stages of change questionnaire, vitals, and self-care behaviors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Number of Hospital Re-admissions from 2 Years Prior to Study Enrollment to 1 Year After Study Completion | Hospital data will be obtained from Revenue and Financial Affairs South Carolina Data Oversight Council. These data come from the health organization where patients receive care and include components such as age, health care facility type, dates of admission/ discharge, length of stay, charges, payment source, primary and secondary procedure codes. | Retrospective billing collection 2 years prior to study enrollment and 1 year after study completion |
| Change of Self-management Success Measured by Diabetes Self-Management Assessment Survey Tool from Baseline to Study Completion | Diabetes self-management assessment tool administered to participant over the phone or in-person | Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Health Goal Progress Captured by Field Notes to Track Intervention Activities from Baseline to Study Completion | Field Notes are completed after each interventionist's interaction with the participant to track progress to addressing health goals | Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion) |
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Inclusion Criteria:
Stage 2 Recruitment:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Jenkins, DrPh, MSN | Medical University of South Carolina | Principal Investigator |
| Samuel Cykert, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Regional Medical Center of Orangeburg and Calhoun Counties | Orangeburg | South Carolina | 29118 | United States |
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| ID | Term |
|---|---|
| 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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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| The Regional Medical Center of Orangeburg and Calhoun Counties | UNKNOWN |
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| Telephonic Nurse Intervention | Behavioral | A nurse will contact patients by phone at least weekly for month 1 and at least every other week for months 2 and 3 and will collect the following information: medication adherence, discharge plan adherence, problem solving, diet and physical activity issues and to assess self-management, dietary, and physical activity improvements. In addition the nurse will link participants with resources. |
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| In-person Community Health Worker | Behavioral | An in-person Community Health Worker will contact patients in-person at least weekly for month 1 and at least every other week for months 2 and 3 and will collect the following information: medication adherence, discharge plan adherence, problem solving, diet and physical activity issues and to assess self-management, dietary, and physical activity improvements. In addition the nurse will link participants with resources. |
|
| Change of Diet Measured By a 24-item Introduction to the Lifestyle Survey from Baseline to Study Completion | The 24-item Introduction to the Lifestyle Survey will be used to assess diet (fats, protein, fruits and vegetables) and at enrollment, week 4 and 12 | Baseline, 1 month post-enrollment, 2 months post-enrollment, 3 months post-enrollment (study completion) |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |