N/A
N=16
Mobile Tablet Education to Advance Caregiver Health
Dementia
Bottom Line
View on ClinicalTrials.gov: NCT03417219 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Change From Baseline Zarit Burden Interview (ZBI) at 4 Months — -2.25; 0.80 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Education and Skill Building Rehabilitation-mobile (ESBR-m) (Behavioral); Usual Care (UC) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Zarit Burden Interview (ZBI) at 4 Months |
-2.25; 0.80 | — |
| PRIMARY Change From Baseline Center for Epidemiological Studies-Depression (CES-D) at 4 Months |
-3.00; 1.60 | — |
| PRIMARY Change From Baseline Perceived Stress Scale (PSS) at 4 Months |
-1.00; 3.40 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03417219). 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.