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| ID | Type | Description | Link |
|---|---|---|---|
| 2P30AG064200-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study will assess the preliminary efficacy of a synchronous/asynchronous psychoeducation program designed to promote caregiving mastery in the immediate time period after a dementia diagnosis. It will also study the effects on caregiver and care recipient well-being.
The Caregiver Bootcamp program will employ psychoeducational methods (expert instruction, expectation of active learning by participants, debriefing and coaching linked to participant reports of application of strategies and principles) to enhance the proposed mechanism of action of the intervention, the enhancement of caregiving mastery - the individual's self-acknowledgement of self-efficacy for coping with the stresses of the new caregiving role.
The program is meant to provide basic orientation to the situation: recognize the reality of the condition; understand the shifts in mindset that the immediate situation demands; begin to recognize the shift in responsibility that will have to occur; and take practical steps to prepare for the future. The program will combine 5 weekly small group 90-120-minute online sessions with asynchronous instructional materials delivered 2-4 days in between sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synchronous/asynchronous online course Participants | Experimental | The program will combine 5 weekly small group (8 participants) 90-120-minute online sessions with asynchronous instructional materials delivered 2-4 days in between sessions. A time suited to all for the synchronous sessions will be identified. The research team will provide instructions for accessing the weekly sessions and asynchronous segments, and mail out supplemental course materials. The team will track online attendance, and the Canvas platform will enable them to monitor each individual's viewing of the asynchronous materials. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synchronous/asynchronous online course | Other |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in caregiver sense of mastery | The seven-item personal mastery scale developed by Pearlin and Schooler is used to measure mastery. All items are rated on a four-point scale: 1 = strongly agree; 2 = agree; 3 = disagree; to 4 = strongly disagree. Total scores ranged from 7 to 28, with higher scores indicating higher levels of mastery. | Baseline, 1 and 3-months post-intervention |
| Change in caregiver self-efficacy: symptom management scale | This outcome will be assessed with Likert scale questions. Includes 6 questions, each scored on a 0-10 scale. Total possible score range is 0-60, with higher score correlating with better study outcome. | Baseline, 1 and 3-months post-intervention |
| Change in caregiver self-efficacy: support services scale | This outcome will be assessed with Likert scale questions. Includes 4 questions, each scored on a 0-10 scale. Total possible score range is 0-40, with higher score correlating with better study outcome. | Baseline, 1 and 3-months post-intervention |
| Change in caregiver self-efficacy: medication management scale | This outcome will be assessed with Likert scale questions. Includes 5 questions, each scored on a 0-10 scale. Total possible score range is 0-50, with higher score correlating with better study outcome. | Baseline, 1 and 3-months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolyn Clevenger, RN, DNP | Contact | 404-712-2394 | carolyn.clevenger@emory.edu | |
| Molly Perkins, PhD | Contact | 404-727-9676 | molly.m.perkins@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carolyn Clevenger, RN, DNP | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nell Hodgson Woodruff School of Nursing | Recruiting | Atlanta | Georgia | 30322 | United States |
Data will be shared with controlled access for general research use as allowed by participants' informed consent and contingent on a requesting institution's Institutional Review Board approval and investigators' approved data sharing plan
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Scientific data will be made available no later than the on-line publication of the main findings from investigators' final dataset and all other generated scientific data will be shared no later than the end of the project award. Study data for the trial will be stored in the Emory Roybal Center repository for at least 5 years.
De-identified data from Roybal-supported trials will be available to qualified researchers through a data sharing agreement that will be fully consistent with NIH data sharing policies and applicable laws and regulations as well as official policies and practices established by the Emory Roybal Center.
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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The investigators will enroll caregivers in six cohorts of 8 each to participate in this Stage Ib clinical trial.
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| D001523 | Mental Disorders |