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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG074255 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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266 family caregivers will be randomly assigned to either immediate intervention or delayed intervention groups. All caregivers will complete baseline surveys and 3 weeks of daily diaries. The immediate intervention group will receive 12 weeks of CuRB-IT. They will complete 3 rounds of 3-week daily diaries followed by an intermittent survey at 12 week intervals for the next 33 weeks. The delayed intervention group will receive 12 weeks of attention, complete 1 round of 3-week daily diaries followed by an intermittent survey, then complete 12 weeks of CuRB-IT, and complete 2 rounds of 3--week daily diaries followed by an intermittent survey at 12-week intervals for the next 18 weeks.
The purposes of the delayed-intervention randomized clinical trial (N=266) are to:
Care-Resistant Behavior Internet Training (CuRB-IT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Intervention | Experimental | Complete baseline survey, complete 3 weeks of daily diaries and intermittent survey, receive 12 weeks of CurB-IT, then complete 3 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries. |
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| Delayed intervention | Active Comparator | Complete baseline survey, complete 3 weeks of daily diaries, receive 12 weeks of attention, complete 3 weeks of daily diaries and 1 intermittent survey, receive 12 weeks of CurB-IT, then complete 2 rounds of 21-day daily diaries and intermittent surveys while receiving attention during the 12-week intervals between daily diaries. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CuRB-IT | Behavioral | 9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers | Experimental and control | Daily during weeks 1, 2, and 3 |
| Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers | Experimental and control | Daily during weeks 15, 16, and 17 |
| Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers | Experimental and control | Daily during weeks 37, 38, and 39 |
| Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers | Experimental and control | Daily during weeks 49, 50, and 51 |
| Change in caregiver responses to dementia-related behaviors | Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment). | Immediately after enrollment |
| Change in caregiver responses to dementia-related behaviors | Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rita A Jablonski, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35244 | United States |
All research data produced by this project will be self-archived at the University of Michigan's NIA-funded National Archive of Computerized Data on Aging. The storage of our research product here will permit many researchers free access to our data in perpetuity. Our archived study will principally include our original (but anonymized) databases as well as any "cleaned," computed, and recoded measures that we produce for or is produced by our analysis. Our project deliverables will include the quantitative databases, a well-documented statistical packaging (SPSS) system file with variable and values labels, a data user guide that includes all SPSS and related computational and analysis syntax code, summary statistics (frequency distributions, means, etc.) for all quantitative variables, a copy of applicable subject consent form, human subject application and the institutional review board (IRB) approval letter, and a blank copy of the survey instrument and interviewer guide.
6 months after conclusion of study; in perpetuity
1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.
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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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| Once at week 15 |
| Change in caregiver responses to dementia-related behaviors | Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment). | Once at week 37 |
| Change in caregiver responses to dementia-related behaviors | Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment). | Once at week 49 |
| Change in caregiver self-efficacy coping skills | Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale. | Immediately after enrollment |
| Change in caregiver self-efficacy coping skills | Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale. | Once at week 15 |
| Change in caregiver self-efficacy coping skills | Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale. | Once at week 37 |
| Change in caregiver self-efficacy coping skills | Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale. | Once at week 49 |
| Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist | Experimental (immediate) | Once at week 15 |
| Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist | Experimental (immediate) | Once at week 37 |
| Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist | Experimental (immediate) | Once at week 49 |
| Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist | Control (delayed) | Once at week 37 |
| Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist | Control (delayed) | Once at week 49 |
| D001523 | Mental Disorders |