Clinical trial NCT03417219: Mobile Tablet Education to Advance Caregiver Health
Official title: Mobile Media Intervention for Family Caregivers of Veterans With Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Caregivers
Family
Veterans
Alzheimer Disease
Memory
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-01-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To address the high burden of caring for a Veteran with dementia, the investigators propose to study the effect of a low-cost, rehabilitative intervention for family caregivers of Veterans with dementia. The investigators' novel approach will use mobile media technology that can reach caregivers in rural areas who do not have easy access to major VA medical centers. If this rehabilitative intervention proves successful, it may represent an approach to Veteran and family-centered dementia care that can be used throughout VA with low staff, resource, and cost burdens.

Detailed description: The proposed project studies the effects of an education and skill-building rehabilitation intervention, designed to be low-cost and clinically translatable through mobile media devices (i.e., tablets), on family caregivers of Veterans with dementia. Intervention effects will be examined longitudinally at baseline and 3 months post-intervention.

Advanced statistical techniques will be used to determine the impact of the intervention on: quality of life in caregivers of Veterans with dementia (Aim 1), perceived stress and depressive symptoms in caregivers (Aim 2), and socialization and engagement in pleasant activities in caregivers (Aim 3).

If this rehabilitative intervention proves successful, it may represent an approach to Veteran- and family-centered dementia care that can be used throughout VA with low staff, resource, and cost burdens.

Eligibility criteria: Inclusion Criteria:

-- Participants must:

* report distress associated with being the primary caregiver for a family member with dementia
* reporting at least 2 of the following 6 items at baseline assessment: felt overwhelmed, felt like they often needed to cry, were angry or frustrated, felt they were cut off from family or friends, reported moderate to high levels of general stress, or felt their health had declined
* provide at least 7 hours of care (supervision or direct assistance) per week over the past 3 months (other sources of caregiving for the Veteran with dementia can also be utilized; e.g., respite, home health aide, other family members)
* cohabitate with a Veteran diagnosed with dementia
* be proficient in spoken and written English
* be capable of providing informed consent

Exclusion Criteria:

-- Potential participants will be screened and excluded for:

* current or lifetime history of any psychiatric disorder with psychotic features
* prominent suicidal or homicidal ideation
* having met DSM-IV criteria for drug or alcohol abuse or dependence (except nicotine) within the past six months
* presence of alcohol intoxication (by breathalyzer) or alcohol withdrawal (by exam) during study recruitment or participation
* diagnosis of probable or possible dementia
* a Telephone Cognitive Screen score of \< 20
* participation in another caregiver intervention study within the past year
* lack of access to telephone and internet services in the home
* illness that would prevent study participation
* planned transfer of care receiver to another caregiver or nursing home within 6 months
* currently living with an implantable cardioverter defibrillator or pacemaker
* known pregnancy at time of consent

Primary outcomes:
measure: Change From Baseline Zarit Burden Interview (ZBI) at 4 Months
timeFrame: Baseline, 4 month follow-up
measure: Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months
timeFrame: Baseline, 4 month follow-up
measure: Change From Baseline Perceived Stress Scale (PSS) at 4 Months
timeFrame: Baseline, 4 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Blake K Scanlon, PhD
role: PRINCIPAL_INVESTIGATOR
References: