Clinical trial NCT04428112: Rural Dementia Caregiver Project
Official title: Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related Dementias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Stress, Psychological
Self Efficacy
Loneliness
Social Isolation
Health Care Utilization
Dementia
Dementia Alzheimers
Dementia of Alzheimer Type
Dementia, Vascular
Dementia Frontal
Dementia, Lewy Body
Dementia, Mixed
Dementia in Parkinsons Disease
Dementia, HIV
Dementia Frontotemporal
Dementia, Multi-Infarct
Keywords: Caregiver
Caregiving
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-06-11
Enrollment: 418
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: These caregivers are a vulnerable group due to their physical isolation and well-documented rural disparities in health care access and quality. Many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Thus, there is a pressing need for effective, scalable, and accessible programs to support rural dementia caregivers.

Online programs offer a convenient and readily translatable option for program delivery because they can be accessed by caregivers in the home and at the convenience of the user. Building Better Caregivers is an online 6-week, interactive, small-group self-management, social support, and skills-building workshop developed for caregivers of individuals with Alzheimer's disease or related dementia.

The investigators will conduct a hybrid effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural dementia caregivers into two groups: the intervention (workshop) group and the attention control group. Caregivers will be recruited throughout the United States. Primary outcomes will be caregiver stress and depression symptoms. The investigators hypothesize that stress scores and depression symptoms will be significantly improved at 12 months in the intervention group versus control group. The investigators will also identify key strengths (facilitators) and weaknesses (barriers) of workshop implementation. The investigators will use the RE-AIM implementation framework and a mixed methods approach to identify implementation characteristics pertinent to both caregivers and rural community organizations.

If the Building Better Caregivers workshop is proven to be effective, this research has the potential to open new research horizons, particularly on how to reach and effectively support isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers, some of those most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in urban or suburban environments).


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or older
* Caring for person with dementia
* Able to read and write in English
* Able to access the internet
* Providing care for ≥ 10 hours per week
* Reporting a minimum stress level of 4 or more on a 10-point scale
* Living in rural area of United States (self-identify or zip code is a Rural Urban Commuting Area Codes (RUCA) defined rural area)

Exclusion Criteria:

* Have an anticipated inability to complete the 12-month follow-up (e.g., planned travel)

Primary outcomes:
measure: Change in visual numeric stress scale score from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Change in Personal Health Questionnaire Depression (PHQ-8) scale score from baseline to 12 months
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Change in Short Caregiver Self-Efficacy scale score from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Change in Zarit Burden Interview-12 (ZBI-12) scale score from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Change in caregiver self-rated general health score from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Change in person with dementia general health score as reported by caregiver from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Change in UCLA loneliness scale score from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Change in Lubben Social isolation scale score from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Change in caregiver health care utilization from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Change in person with dementia health care utilization as reported by caregiver from baseline to 12 months
timeFrame: Baseline and 12 months
Other outcomes:
measure: Change in caregiver benefits scale score from baseline to 12 months
timeFrame: Baseline and 12 months
measure: Change in exercise behavior scale score from baseline to 12 months
timeFrame: Baseline and 12 months
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Veronica Yank, MD
role: PRINCIPAL_INVESTIGATOR
References: