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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG082833-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Institute on Aging (NIA) | NIH |
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This study is designed to learn more about ways to promote caregiver mastery online. 270 dementia family caregivers will be enrolled and randomized to take the CAN-DO online course immediately or after a waiting period. They will participate in interviews before and after the course; total time of study participation is 6 months.
Family members and friends are the core of the uncoordinated system of care that tenuously maintains persons living with dementia in their community settings and delays their placement into more costly settings of institutional care, providing more contributed and out of pocket care support than Medicare and Medicaid combined.
The CAN-DO program fills a significant gap in caregiver psychoeducation programming by focusing not principally on day-to-day care management but on the many substantial system navigation tasks that caregivers assume. Supported by preliminary efficacy data, CAN-DO will employ state-of-the art asynchronous interactive learning methods to enhance caregivers' mastery of skills and confidence to navigate healthcare and other (legal, financial, social service, and family) systems that are crucial to the continued community living of persons affected with dementia illnesses.
This study will enroll 270 dementia family caregivers who will be randomized to take the CAN-DO course immediately or after a waiting period. They will participate in interviews before and after the course; total time of study participation is 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAN-DO Immediate program group | Experimental | Each participant will be engaged in a baseline interview. Subsequently, each will be asked to take part in follow-up interviews at points 2, 4, 6, and 8 months following the launch of their cohort. |
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| Attention Control program group | Active Comparator | Participants will receive an online course about "Healthy Living" for the first 4 months after randomization. After the Attention Control participants complete their 4-month interview, they will be invited to participate in the CAN-DO program. |
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| Usual care group | Active Comparator | Participants randomized to the Usual care group will not receive intervention from the study but after they complete their 4-month interview, they will be invited to participate in the CAN-DO program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caregiver as Navigator: Develop Skills Online (CAN-DO) program | Other | Online, asynchronous psychoeducation program for dementia family caregivers. The program is meant to enhance caregivers' knowledge and skills for navigating healthcare, financial, legal, and family systems. The program has three main sections.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Pearlin Caregiver Stress Scales score | This primary outcome will measure Caregiver Mastery (including Competence, Confidence, Management of Situation). The Pearlin caregiver scale includes 8 items, with a rating from 1-4 for each of them. Total possible score range is 8-32. Higher score correlates with better outcome. | Baseline, 2, 4, 6, and 8 months post-intervention |
| Change in Caregiver Assessment of Behavioral Skill scale score | This study outcome will also measure Caregiver Mastery. Caregiver Assessment of Behavioral Skills score will be assessed using the Fortinsky scale that includes 17 items rated from 0-3 each. Possible score range is 0-51. Higher score correlates with better outcome. | Baseline, 2, 4, 6, and 8 months post-intervention |
| Change in State-Trait Anxiety Scale score | This outcome will measure Caregiver Emotional Wellbeing. The State-Trait Anxiety Scale includes 20 items, each of them rated 1-4. Total possible score range 20-80 with higher score correlated with better study outcome. | Baseline, 2, 4, 6, and 8 months post-intervention |
| Change in Perceived Stress Scale score | This outcome will measure Caregiver Emotional Wellbeing. The Perceived Stress Scale includes 10 items, each of them rated 1-5, with a total possible score 10-50. Lower score correlates with better study outcome. | Baseline, 2, 4, 6, and 8 months post-intervention |
| Change in Caregiver Burden Index | This outcome will measure Caregiver Emotional Wellbeing. The caregiver burden Index includes 22 items, each of them rated 0-4, with a total possible score 0-88. Lower score correlates with better study outcome. | Baseline, 2, 4, 6, and 8 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Revised Memory and Behavior Problem Checklist score | This outcome will assess Care Recipient Quality of Life. Total possible score: 0-96; Higher score correlates with worse outcome. | Baseline, 2, 4, 6, and 8 months post-intervention |
| Change in Quality of Life in Alzheimer's score |
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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 | |
| Mia Chester | Contact | mia.chester@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carolyn Clevenger, RN, DNP | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory Roybal Center for Dementia Caregiving Mastery | Recruiting | Atlanta | Georgia | 30322 | United States |
De-identified aggregate data will be shared. Transcripts from interviews with patients and healthcare providers will be de-identified and sensitive content redacted where identification is plausible. These de-identified and redacted transcripts and coding summaries will be shared. All shared data sets and metadata will be made publicly available through Emory's Dataverse data repository. Documentation and support materials (e.g., survey questions with value sets and interview questions).
Final data submission and release of data used in publications will occur approximately 8 and 12 months following the end of fieldwork, respectively. Datasets underlying publications will be shared at or prior to initial publication date. Data will not be published or will not be shared before the end of this award. Shared data will be preserved according to Emory's Dataverse data repository data retention policy. The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period.
Data will be available by controlled access only. Research participants will receive information about where and how data from this study will be shared during study enrollment procedures and in informed consent documents. Interview participants will be informed their data will be shared on Emory's Dataverse data repository with controlled access for future use. Participants who want to withdraw their data from the study prior to de-identification may contact the study team or the university's research administration office.
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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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| ID | Term |
|---|---|
| D017028 | Caregivers |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Healthy Living online course | Other | Online program for dementia family caregivers about "Healthy Living" for the first 4 months post-randomization. |
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| Change in Dyadic Relationship Scale score | This outcome will assess Caregiver Emotional Wellbeing. The Dyadic Relationship Scale includes 11 items rated from 1 to 4, with a total possible score range 11-44. Higher score correlates with better outcome. | Baseline, 2, 4, 6, and 8 months post-intervention |
This outcome will assess Care Recipient Quality of Life. The total possible score is 13-52; Higher score correlates with better outcome. |
| Baseline, 2, 4, 6, and 8 months post-intervention |
| D001523 | Mental Disorders |