N/A
N=82
Optimizing Dementia Care
Alzheimer's Disease · Dementia · Dementia, Vascular · Caregivers · Veterans
Bottom Line
View on ClinicalTrials.gov: NCT02585232 ↗Enrolled (actual)
82
Serious AEs
14.6%
Results posted
Sep 2021
Primary outcome: Primary: Change From Baseline in Caregiver Burden Scores on the Zarit Caregiver Burden Inventory — -2.38; 0.22 change units on a scale — p=.483
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Counseling (C) (Behavioral); Care Consultation (CC) (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Caregiver Burden Scores on the Zarit Caregiver Burden Inventory |
-2.38; 0.22 | .483 |
| PRIMARY Change From Baseline in Relationship Cohesion on the Dyadic Adjustment Scale |
6.44; -2.64 | 0.169 |
| PRIMARY Change From Baseline in Quality of Life on the World Health Organization (WHO) Quality of Life Measure |
.59; -2.97 | 0.763 |
| PRIMARY Change From Baseline Depressive Symptoms on the Cornell Scale for Depression in Dementia |
-2.000; -1.100 | 0.780 |
| SECONDARY Number and Percentage of Veterans With Dementia in Long-term Care Facilities as Reported by the Caregivers at 12 Months |
3; 3 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02585232). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.