Clinical trial NCT02585232: Optimizing Dementia Care
Official title: Optimizing Dementia Care Through Collaborative Recovery Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Dementia
Dementia, Vascular
Caregivers
Veterans
Keywords: Behavioral sciences
Counseling
Intervention Studies
Cognitive Behavioral Therapy
Telemedicine
Mindfulness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-10-23
Enrollment: 86
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Background: Dementia affects over 7% of Veterans age 65 and above seeking care through the Veteran's Health Administration (VHA), amounting to one out of every eleven Veterans in some VISNs. The unique functional and behavioral impairments associated with Alzheimer's or a related dementia (ADRD) contribute substantially to psychological and physical morbidity of family caregivers and high rates of nursing home placement, with 60% of ADRD caregivers rating the emotional stress of caregiving as "high or very high," and over one third reporting depressive symptoms. Although numerous evidence-based interventions have been developed to reduce caregiver burden and improve mental health and functional outcomes of the person with dementia, a recent systematic review noted almost none of these interventions "make it off of the shelf" to be readily available in clinical settings. Care Consultation (CC) has emerged as a rare exception. CC is an evidence-based telephone intervention delivering psychoeducation, care coordination, and resource referrals in diverse areas such as safety and mental and behavioral health support. Yet CC's focus on coaching and support is inadequate for dyads experiencing high levels of distress. A stepped-intervention approach would address the VA's efficiency needs while allowing the flexibility for more resource-intensive additional counseling beyond the established CC framework when warranted by high dyad distress. This CDA-2 proposal would move such a dyadic intervention forward.

Objectives: 1) Manualize the integration of care consultation and counseling components (i.e., the CC+C intervention). CC+C is guided by a rehabilitation recovery-based conceptual model to address the most common high distress targets (e.g., relationship distress, Veteran or caregiver depression, anxiety, or pain) using patient-centered approaches. 2) Evaluate preliminary effectiveness and feasibility of the CC+C Intervention in a randomized controlled pilot study of distressed dyads to compare: a) the established CC intervention, to b) the CC+C intervention on Veteran and caregiver outcomes. 3) Conduct exploratory analyses of the CC+C intervention on Veteran long-term care placement at six and 12 months and examine two key treatment moderators (behavioral symptoms and spousal relationship status) that may impact intervention engagement and response to treatment.

The investigators hypothesize that: 1) Caregivers assigned to CC+C will have greater reductions in caregiver burden at 6 months than those assigned to CC alone. 2) Indicators of relationship strain (i.e., marital distress and/or mutuality) will show greater improvement in CC+C than CC at 6 months. 3) Gains in shared pleasant events, social engagement, and quality of life will be greater in CC+C than in CC alone at 6 months. 4) Participants with dementia in both groups will have reduced depressive symptoms at 6 months. The investigators will also explore the impact of the two interventions on rates of placement in long-term care facilities (such as nursing homes, VA Community Living Centers or other supportive living environments) at 6 and 12 months.

Methods: Ten modules combining successful elements from existing manualized therapies and exercises developed by the investigative team during the CDA1 period will be integrated with CC into a draft CC+C intervention manual. The manual will be finalized with input from the mentoring team and an Expert Advisory Panel for completeness, feasibility, and safety and risk considerations. Next 68 distressed Veterans with dementia and their family caregivers will be recruited and randomized to either the CC+C intervention group or the CC comparison group. Patient, caregiver, and relationship outcomes (e.g., burden, depressive symptoms, anxiety, quality of life, relationship distress) will be measured at baseline, 6 months, and 12 months. Treatment implementation and feasibility data will be collected.

Anticipated Impacts: The goal of this career development study is to acquire the knowledge, skills and experience necessary to successfully compete for an RR\&D Merit Review Award evaluating a randomized controlled trial powered to establish efficacy and test effectiveness of the CC+C intervention. Rehabilitation-focused interventions that maximize functioning are essential for successful non-institutional VA dementia care in the future. Work completed during the CDA2 period will serve as a foundation for a career committed to this goal. The impact of this work will be realized when an efficacious and highly-accessible intervention, such as the telephone-based dyadic intervention being piloted, becomes available for aging Veterans and their families.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Caregiver Burden Scores on the Zarit Caregiver Burden Inventory
timeFrame: Baseline, 6 months
measure: Change From Baseline in Relationship Cohesion on the Dyadic Adjustment Scale
timeFrame: Baseline, 6 months
measure: Change From Baseline in Quality of Life on the World Health Organization (WHO) Quality of Life Measure
timeFrame: Baseline, 6 months
measure: Change From Baseline Depressive Symptoms on the Cornell Scale for Depression in Dementia
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Number and Percentage of Veterans With Dementia in Long-term Care Facilities as Reported by the Caregivers at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa VA Medical Center, Tuscaloosa, AL
state: Alabama
Study officials:
affiliation: Tuscaloosa VA Medical Center, Tuscaloosa, AL
name: Michelle M Hilgeman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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. doi: 10.1093/geront/43.1.73.