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| ID | Type | Description | Link |
|---|---|---|---|
| P01NR011587 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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More and more family members are providing care to their loved ones with prolonged and progressive illnesses. Chronic intense caregiving represents a situation of chronic stress, which takes a toll on one's mental and physical health including an increased risk for the development or worsening of heart disease. Identification of effective self-care interventions for family caregivers is warranted to improve their emotional wellbeing and minimize the harmful effects of chronic stress on the heart. This Program Project Grant aims to promote health and reduce cardiovascular risk in family caregivers (FCG) of persons with chronic illness. In two studies the investigators will test two interventions, psycho-education(ED) and physical exercise(EX), individually and in combination. The first study will target FCG of African American dementia patients; the second will focus on FCG of heart failure patients. Parallel designs, interventions and measures will create synergy as will integration of all data management and analyses within a Bio-behavioral Science and Measures Core. This Core will also provide high level guidance and interpretation of model testing resulting from analysis of the common data set. The combined de-identified data set will allow for elucidating the biological mechanisms of stress-induced cardiovascular risk, further developing the model, and stimulating future research, while the shared core support will provide substantial efficiency; neither could be achieved outside of a Program Project approach. These collective efforts will generate important data whereby future care can significantly enhance the lives of FCG and minimize their risk of cardiovascular disease, the number one cause of disability and death in the United States.
We hypothesize that FCGs who receive the combined PSYCHED+EX intervention will have better psychological functioning (lower levels of depressive symptoms, anxiety, and caregiver burden and higher levels of flourishing), behavioral outcomes (improved sleep quality and greater physical function), cardiovascular risk measures (improved resting heart rate, blood pressure, heart rate recovery, oxygen consumption, lipids, glucose, and inflammatory markers), neuroendocrine function (salivary cortisol) and overall health outcomes (improved function, muscle strength, and endurance) compared to psycho-education and usual care-attention control from baseline to six months later mediated by improvements in process outcomes (lower perceived stress and higher self-efficacy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Attention Control | Sham Comparator | Provision of printed educational material and attendance at one group session. This session will focus on nutrition education and flexibility and stretching. |
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| Psychoeducation plus exercise | Experimental | Psychoeducation intervention plus an individualized exercise program which will include monitored, individually-prescribed aerobic and resistance exercise. |
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| Psychoeducation | Active Comparator | Psychoeducational program to involve group sessions over consecutive weeks. The sessions will use the principles of adult learning, emphasizing active learning, group exercises and discussion, and coaching as well as brief talks to provide content. The curriculum will focus on the strengthening of caregiver self-efficacy through enhancement of knowledge and understanding, the acquisition, strengthening, and practice of caregiving skills, and the development of a more clinical or strategic outlook on the caregiving role. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Behavioral | Educational materials |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Emotional outcomes | Depression, Anxiety, Caregiver Burden, Flourishing | Baseline and 6 months |
| Behavioral Outcomes | Physical Activity, Sleep Quality | Baseline and 6 months |
| Health Status | Function, Muscle strength, endurance | Baseline and 6 months |
| Neuroendocrine | Salivary Cortisol | Frame Baseline and 6 months |
| Cardiovascular Risk Outcomes | Biochemical Markers (Inflammation Coagulation Insulin Resistance) Cardiovascular Reactivity & Risk | Baseline and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Miller, MD | Emory University | Principal Investigator |
| Kenneth Hepburn, PhD | Emory University | Study Chair |
| Sandra Dunbar, DSN | Emory University | Study Chair |
| Monica Parker, MD | Emory University | Study Chair |
| Elizabeth J Corwin, PhD | Emory University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Universtiy | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29708007 | Derived | Corrigendum. J Appl Gerontol. 2020 Feb;39(2):NP1. doi: 10.1177/0733464818775576. Epub 2018 Apr 30. | |
| 29347863 | Derived | Gary R, Dunbar SB, Higgins M, Butts B, Corwin E, Hepburn K, Butler J, Miller AH. An Intervention to Improve Physical Function and Caregiver Perceptions in Family Caregivers of Persons With Heart Failure. J Appl Gerontol. 2020 Feb;39(2):181-191. doi: 10.1177/0733464817746757. Epub 2018 Jan 18. |
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| ID | Term |
|---|---|
| D001519 | Behavior |
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Psycho-education |
| Behavioral |
Educational group sessions |
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| Psycho-education plus physical exercise | Behavioral | Psychoeducation intervention plus an individualized exercise program |
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| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |