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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR011888-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Atlanta VA Medical Center | FED |
| Atlanta Clinical and Translational Science Institute | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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The purposes of this study are:
The intervention is designed to go beyond usual care of providing separate Heart Failure (HF) and Diabetes (DM) patient education by educating HF-DM patients on integrated self care and self management related to a HF-DM diet, HF-DM medication-taking behaviors, physical activity, and HF-DM symptom monitoring and management. An integrated self care intervention will compare HF-DM patients who receive the intervention with those who receive usual care-attention control for effects on patient outcomes,self care process measures, and health care utilization. If effective, the intervention will lead to improved self care, improved quality of life, and reduced health care resource use and costs. This study will facilitate greater understanding of self care within the context of two chronic illnesses and will lead directly to improved clinical practice and future research on comorbid self care in Heart Failure.
The investigators hypothesize that participants receiving the Heart Failure and Diabetes (HF-DM) self-care intervention will report greater Health Related Quality of Life (HRQOL) on the Minnesota Living with HF Questionnaire (MLHFQ), the Audit of Diabetes-dependent Quality of Life (ADDQoL), and the EuroQol (EQ5D) than the Usual Care (UC-AC) group at 6 months when controlling for age, gender, and NYHA Class.
Secondly, that participants receiving the Heart Failure and Diabetes (HF-DM) self-care intervention will demonstrate improved physical function indicators (BNP levels, HgA1c, and 6MWT) at 6 months over the UC-AC group when controlling for age, gender, BMI, and NYHA Class and comorbid conditions.
Thirdly, that participants receiving the Heart Failure and Diabetes (HF-DM) self-care intervention will exhibit greater improvement in: HF knowledge and DM knowledge than UC-AC at 6 months. Participants receiving the integrated HF-DM self-care intervention will report greater improvements in HF self-efficacy and DM self-efficacy over UC-AC at 6 months. HF-DM patients randomized to the integrated self-care intervention will exhibit greater improvements in overall HF and DM self-care behaviors and HF-DM diet and physical activity over UC-AC at 6 months.
Lastly, that HF-DM patients who receive the integrated self-care intervention will exhibit less health resource use and associated costs(direct health care costs of provider visits, hospitalizations, ED visits, length of stay, and direct non-health care costs associated with the HRU and intervention) over the 6 months than those who receive UC-AC controlling for comorbidity and insurance status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HF-DM Self Care | Experimental | educational counseling intervention about integrated HF-DM self care outcomes |
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| Usual Care | No Intervention | Usual Care provided by providers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HF DM self care | Behavioral | Education in monitoring signs and symptoms of Heart Failure and Diabetes as well as self care instruction |
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| Measure | Description | Time Frame |
|---|---|---|
| Heart failure health related quality of life measures | As measured by Minnesota Living with Heart Failure Questionnaire (MLHFQ). | 6 months |
| Diabetes health related quality of life measures | As measured by Audit of Diabetes - Dependent Quality of Life (ADDQOL). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure and Diabetes (HF-DM) physical outcomes | BNP and HgA1c, and 6 minute walk test | 6 months |
| Heart Failure Knowledge | As measured by the Atlanta Heart Failure Knowledge Test (AHFKT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra B Dunbar, PhD | Nell Hodgson Woodruff School of Nursing | Principal Investigator |
| Javed Butler, MD | Emory University | Study Director |
| Stephen Culler, MD | Emory University | Study Director |
| Rebecca A. Gary, PhD | Nell Hodgson Woodruff School of Nursing | Study Director |
| Carolyn M. Reilly, PhD | Nell Hodgson Woodruff School of Nursing | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University School of Nursing | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26164214 | Derived | Reilly CM, Butler J, Culler SD, Gary RA, Higgins M, Schindler P, Butts B, Dunbar SB. An economic evaluation of a self-care intervention in persons with heart failure and diabetes. J Card Fail. 2015 Sep;21(9):730-7. doi: 10.1016/j.cardfail.2015.06.382. Epub 2015 Jul 8. | |
| 26028261 | Derived | Dunbar SB, Reilly CM, Gary R, Higgins MK, Culler S, Butts B, Butler J. Randomized clinical trial of an integrated self-care intervention for persons with heart failure and diabetes: quality of life and physical functioning outcomes. J Card Fail. 2015 Sep;21(9):719-29. doi: 10.1016/j.cardfail.2015.05.012. Epub 2015 May 29. |
| Label | URL |
|---|---|
| Research at Emory's School of Nursing | View source |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Usual Care | Behavioral | Educational materials on Heart Failure and diabetes at study enrollment. Full educational binder delivered at end of study. |
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| 6 months |
| Health resource use | As measured by hospital and ED visits as well as contact with medical providers | 6 months |
| Heart Failure (HF) self-efficacy | As measured by Self Care in Heart Failure Inventory Self Efficacy Scale | 6 months |
| Heart Failure and Diabetes(HF-DM) self-care behaviors | As measured by activity calendars/logs, Self care in Heart failure Inventory subscales, and Summary of Diabetes Self Care Scale | 6 months |
| Diabetes (DM) Knowledge | Michigan Diabetes Knowledge Test (MDKT) | 6 months |
| Diabetes (DM) self efficacy | Measured by the Perceived Diabetes Self Management Scale (PDSMS) | 6 months |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |