Rural Dementia Caregiver Project

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04428112
• Other study ID #: 18-25814
• Secondary ID: 5R01AG057855-023
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: October 16, 2023

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Aphasia, Primary Progressive
• CADASIL
• Dementia
• Dementia Alzheimers
• Dementia Frontal
• Dementia Frontotemporal
• Dementia in Parkinsons Disease
• Dementia of Alzheimer Type
• Dementia, HIV
• Dementia, Lewy Body
• Dementia, Mixed
• Dementia, Multi-Infarct
• Dementia, Vascular
• Depression
• Frontotemporal Dementia
• Health Care Utilization
• Lewy Body Disease
• Loneliness
• Parkinson Disease
• Pick Disease of the Brain
• Self Efficacy
• Social Isolation
• Stress, Psychological

Intervention

Behavioral:
• Building Better Caregivers Workshop
Workshops consist of small group or about 20-25 persons. Two peer co-facilitators (caregiver themselves) will guide workshop activities. Participants will receive a workshop booklet. Each week, participants will log on at least 2-3 times for a total time of approximately two hours. Participants do not require "real time" attendance at pre-determined times.
• Attention Control
Participants will receive two brief 15-30 minutes phone calls by study staff, and will receive a handbook on dementia and caregiver resources while they wait for the workshop.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in caregiver benefits scale score from baseline to 12 months	4-items measuring potential benefits of caregiving (e.g., providing care made caregiver feel useful, closer to care partner, good about self, and allowed caregiver to learn new skills) from the Health and Retirement Study. The scale score is calculated by summing each item to produce a total score between 0 and 4, with higher scores indicating better outcome.	Baseline and 12 months
Other	Change in exercise behavior scale score from baseline to 12 months	6-items measuring exercise behaviors. Exercise behaviors include stretching/strengthening; walking; swimming/aquatic; bicycling (including stationary bikes); other aerobic exercise equipment (stairmaster, rowing, etc.); or other aerobic exercise. The scale score is calculated by summing each item to produce a total score between 0 and 1080, with higher scores indicating better outcome.	Baseline and 12 months
Primary	Change in visual numeric stress scale score from baseline to 12 months	A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.	Baseline and 12 months
Primary	Change in Personal Health Questionnaire Depression (PHQ-8) scale score from baseline to 12 months	Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.	Baseline and 12 months
Secondary	Change in Short Caregiver Self-Efficacy scale score from baseline to 12 months	Short Caregiver Self-Efficacy scale (8-items). The scale scores is calculated by taking the mean of the items to produce a total score between 1 and 10, with higher scores indicating better outcome.	Baseline and 12 months
Secondary	Change in Zarit Burden Interview-12 (ZBI-12) scale score from baseline to 12 months	Short form of the Zarit Burden Interview-12 (ZBI-12) scale (12-items). The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.	Baseline and 12 months
Secondary	Change in caregiver self-rated general health score from baseline to 12 months	Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 self-rated general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome.	Baseline and 12 months
Secondary	Change in person with dementia general health score as reported by caregiver from baseline to 12 months	Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 caregiver-reported general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome.	Baseline and 12 months
Secondary	Change in UCLA loneliness scale score from baseline to 12 months	UCLA loneliness scale (3-items). The scale score is calculated by summing each item to produce a total score between 3 and 9, with higher scores indicating worse outcome.	Baseline and 12 months
Secondary	Change in Lubben Social isolation scale score from baseline to 12 months	Lubben Social isolation scale (6-items). The scale score is calculated by summing each item to produce a total score between 0 and 30, with lower scores indicating worse outcome.	Baseline and 12 months
Secondary	Change in caregiver health care utilization from baseline to 12 months	3-items measuring overnight hospitalizations, nursing home or other long-term care facility use, and hospital emergency room visits from the Health and Retirement Study, modified time frame from self-report for past 12 months to self-report for past 6 months; scored as single items; with higher scores indicating worse outcome.	Baseline and 12 months
Secondary	Change in person with dementia health care utilization as reported by caregiver from baseline to 12 months	3-items measuring overnight hospitalizations, nursing home or other long-term care facility use, and hospital emergency room visits from the Health and Retirement Study, modified time frame from caregiver report for past 12 months to caregiver report for past 6 months; scored as single items; with higher scores indicating worse outcome.	Baseline and 12 months