Dementia Clinical Trial
— ODeCOfficial title:
Optimizing Dementia Care Through Collaborative Recovery Interventions
Verified date | December 2021 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this randomized controlled pilot study is to examine the preliminary effectiveness, feasibility, and potential treatment moderators (i.e., behavioral symptoms and spousal relationship status) of a newly developed intervention for individuals with dementia and their family caregivers that combines elements of the established care consultation (CC) approach with additional counseling modules (CC+C). Outcomes for Veterans with dementia and their family caregivers (e.g., depressive symptoms, care-related burden, quality of life, pleasant events, etc.) will be assessed after 6 months of treatment and again at 12 months.
Status | Completed |
Enrollment | 86 |
Est. completion date | October 22, 2020 |
Est. primary completion date | August 5, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: Veterans: - Must be age 19 or older - Must have a diagnosis of dementia or a related disorder - Must live in the community (i.e. not in a VA Community Living Center, nursing home, or other facility) - Must cohabitate with a caregiver - Must have reliable access to a telephone - Must be willing to consent to participate or provide assent in conjunction with proxy consent if their decision-making capacity is compromised Caregivers: - Must be age 19 or older - Must self-identify as assisting with care for at least 8 hours/week - Must be willing to consent to participate Exclusion Criteria: Veterans: - Currently incarcerated - Currently pregnant - Dyads experiencing low levels of distress Caregivers: - Currently incarcerated - Currently pregnant - Experiencing severe cognitive impairment that would impair their ability to communicate during an interview - Dyads experiencing low levels of distress |
Country | Name | City | State |
---|---|---|---|
United States | Tuscaloosa VA Medical Center, Tuscaloosa, AL | Tuscaloosa | Alabama |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Bass DM, Clark PA, Looman WJ, McCarthy CA, Eckert S. The Cleveland Alzheimer's managed care demonstration: outcomes after 12 months of implementation. Gerontologist. 2003 Feb;43(1):73-85. — View Citation
Bass DM, Judge KS, Snow AL, Wilson NL, Morgan R, Looman WJ, McCarthy CA, Maslow K, Moye JA, Randazzo R, Garcia-Maldonado M, Elbein R, Odenheimer G, Kunik ME. Caregiver outcomes of partners in dementia care: effect of a care coordination program for veterans with dementia and their family members and friends. J Am Geriatr Soc. 2013 Aug;61(8):1377-86. doi: 10.1111/jgs.12362. Epub 2013 Jul 19. — View Citation
Bass DM, Judge KS, Snow AL, Wilson NL, Morgan RO, Maslow K, Randazzo R, Moye JA, Odenheimer GL, Archambault E, Elbein R, Pirraglia P, Teasdale TA, McCarthy CA, Looman WJ, Kunik ME. A controlled trial of Partners in Dementia Care: veteran outcomes after six and twelve months. Alzheimers Res Ther. 2014 Feb 28;6(1):9. doi: 10.1186/alzrt242. eCollection 2014. — View Citation
Judge KS, Bass DM, Snow AL, Wilson NL, Morgan R, Looman WJ, McCarthy C, Kunik ME. Partners in dementia care: a care coordination intervention for individuals with dementia and their family caregivers. Gerontologist. 2011 Apr;51(2):261-72. doi: 10.1093/geront/gnq097. Epub 2011 Jan 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Caregiver Burden Scores on the Zarit Caregiver Burden Inventory | The Zarit Caregiver Burden Inventory is a measure of strain related to providing care for someone with dementia. Scores range from 0 to 48 with higher scores indicating more caregiver burden. | Baseline, 6 months | |
Primary | Change From Baseline in Relationship Cohesion on the Dyadic Adjustment Scale | Relationship satisfaction and cohesion measure for spouses and partners in a romantic relationship. Scores range from 0 to 151, and higher scores indicate higher levels of relationship satisfaction. Not all caregivers were in a romantic relationship with the person with dementia, this scale was only administered to dyads who were married or partnered (e.g., adult children caregivers would not have received this measure). | Baseline, 6 months | |
Primary | Change From Baseline in Quality of Life on the World Health Organization (WHO) Quality of Life Measure | Change in shared pleasant events, social engagement, and quality of life is hypothesized to be greater in caregivers assigned to CC+C than in CC alone at 6 months. Scores range from 19 to 95, and higher scores indicate better quality of life. | Baseline, 6 months | |
Primary | Change From Baseline Depressive Symptoms on the Cornell Scale for Depression in Dementia | Depression symptoms measure, scores range from 0 to 38 with higher scores indicating more depressive symptoms as rated by their caregiver. | Baseline, 6 months | |
Secondary | Number and Percentage of Veterans With Dementia in Long-term Care Facilities as Reported by the Caregivers at 12 Months | Number and percentage of Veterans with dementia in long-term care facilities as reported by the caregivers at 12 months. | 12 months |
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