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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG082892-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each intervention. The main questions it aims to answer are:
Participants who enroll will agree to enroll will:
Researchers will compare the two groups of caregivers on the following outcomes: self-care, caregiver self-efficacy (aka confidence), coping, stress, and health status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Health Information (DHI) | Active Comparator | Digital health information is delivered through a website tailored with care transitions and self-care information for all participants over the 6-month study. |
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| Virtual Health Coaching + DHI | Experimental | Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Health Information (DHI) | Other | Digital health information websites. |
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| Measure | Description | Time Frame |
|---|---|---|
| Self-Care Inventory | The Self-Care Inventory (SCI) measures self-care maintenance, monitoring, management, and self-efficacy. Each subscale is standardized on a 0-100 point scale. Higher scores indicate better self-care. | Collected at: enrollment, 3- and 6-months after enrollment |
| Health Self-Care Neglect | This a binary that scale captures the level of self-care neglect, with higher scores indicating greater neglect. | Collected at: enrollment, 3- and 6-months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale | The perceived stress scale has 10 items rated on a 5-point scale rating perceptions of stress. | Collected at: enrollment, 3- and 6-months after enrollment |
| Brief COPE | This tool is designed to assess the varying coping strategies used by individuals in response to stress. |
| Measure | Description | Time Frame |
|---|---|---|
| Experience with Care | This 10-item tool evaluates the experience with care post-hospital discharge. Each item is measured on a scale of 1-4 with 4 indicating they strongly agree with each statement. | Collected at 1 month post index-hospital discharge |
| Acute care resource use outcomes for patients of caregivers |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Hirschman, Ph.D. | Contact | 215-573-3755 | hirschk@nursing.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karen Hirschman, Ph.D. | University of Pennsylvia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennsylvania Hospital | Recruiting | Philadelphia | Pennsylvania | 19104-4212 | United States |
Individual participant self-report data collected during the trial that underlie the results of the primary outcome will be shared after de-identification.
Data will be available as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, whichever is earlier. Data will be preserved for at least five years following the end of the grant period.
Individual-level data will be shared with controlled access as allowed by informed consent agreements approved by the University of Pennsylvania Institutional Review Board (IRB). Data sharing and confidentiality agreements as established by the university or future data repository will be required.
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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This randomized single-group interventional study caregivers of recently hospitalized older adults will receive either digital health information (DHI) alone or a virtual health coaching intervention (Virtual Caregiver Coach for You, ViCCY) with DHI. Health resource data on the patients of the enrolled caregivers will be collected.
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The Principal Investigator will be blinded to group assignment.
| Virtual Health Coach for You | Behavioral | Study participants in the intervention group will receive 10-session virtual health coaching intervention session delivered over 6 months with the goal of improving caregiver self-care and coping, decreasing stress, and improving the hospital-to-home experience The 10 sessions are on average 60 minutes and cover the following topics: care transitions, caregiving demand, self-care, and coping. |
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| Collected at: enrollment, 3- and 6-months after enrollment |
| Caregiver Self-Care Self-Efficacy Scale | This scale measures caregiving self-efficacy in multiple areas. Each item is measured on a scale of 1-5 with 5 indicating they are the most confident in that area. | Collected at: enrollment, 3- and 6-months after enrollment |
| Preparedness for Caregiving Scale | This scale measures how prepared caregivers feel to provide support for their loved ones in multiple areas. Each item is measured on a scale of 0-4 with 4 indicating they are the most prepared in that area. | Collected at: enrollment, 3- and 6-months after enrollment |
| Quality of the relationship | This scale measures giving and receiving support in multiple areas. Each item is measured on a scale of 0-4 with 4 indicating they are the most positive in that area. | Collected at: enrollment, 3- and 6-months after enrollment |
| RAND Medical Outcomes Study Short Form (SF-36) | This scale that uses multiple measures to determine overall mental and physical health. Higher scores indicate better mental and physical health. | Collected at: enrollment, 3- and 6-months after enrollment |
Hospitalizations and emergency department visits or the patients of caregivers during the 6 months after the caregiver enrolls. |
| Data over 6 months |
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Penn Presbyterian Medical Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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