Rural Dementia Caregiver Project

• ClinicalTrials.gov Identifier: NCT04428112
• Recruitment Status: Recruiting
• First Posted: June 11, 2020
• Last Update Posted: August 8, 2022
• Sponsor: University of California, San Francisco
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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).

Condition or disease	Intervention/treatment	Phase
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	Behavioral: Building Better Caregivers Workshop; Behavioral: Attention Control	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 640 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: June 5, 2020
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: May 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Building Better Caregivers Workshop Group; Building Better Caregivers Workshop is a 6-week online self-management and skills building workshop. Participants receive the online workshop as soon as possible after randomization.	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.
Active Comparator: Attention Control Group; Participants will be offered the online workshop after the 12 month trial is completed if they so desire.	Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Change in visual numeric stress scale score from baseline to 12 months [ Time Frame: Baseline and 12 months ]
   A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
2. Change in Personal Health Questionnaire Depression (PHQ-8) scale score from baseline to 12 months [ Time Frame: Baseline and 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.

Secondary Outcome Measures :

1. Change in Short Caregiver Self-Efficacy scale score from baseline to 12 months [ Time Frame: Baseline and 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.
2. Change in Zarit Burden Interview-12 (ZBI-12) scale score from baseline to 12 months [ Time Frame: Baseline and 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.
3. Change in caregiver self-rated general health score from baseline to 12 months [ Time Frame: Baseline and 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.
4. Change in person with dementia general health score as reported by caregiver from baseline to 12 months [ Time Frame: Baseline and 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.
5. Change in UCLA loneliness scale score from baseline to 12 months [ Time Frame: Baseline and 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.
6. Change in Lubben Social isolation scale score from baseline to 12 months [ Time Frame: Baseline and 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.
7. Change in caregiver health care utilization from baseline to 12 months [ Time Frame: Baseline and 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.
8. Change in person with dementia health care utilization as reported by caregiver from baseline to 12 months [ Time Frame: Baseline and 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.

Other Outcome Measures:

1. Change in caregiver benefits scale score from baseline to 12 months [ Time Frame: Baseline and 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.
2. Change in exercise behavior scale score from baseline to 12 months [ Time Frame: Baseline and 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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)

Contacts and Locations

Contacts

Contact: Veronica Yank, MD; 415-476-9654; veronica.yank@ucsf.edu

Contact: Jasmine Santoyo-Olsson, MS; 1-833-634-0603; jasmine.santoyo-olsson@ucsf.edu

Locations

United States, California

University of California, San Francisco; Recruiting

San Francisco, California, United States, 94118

Contact: Veronica Yank, MD 415-476-9654 veronica.yank@ucsf.edu

Contact: Jasmine Santoyo-Olsson, MS 1-833-634-0603 jasmine.santoyo-olsson@ucsf.edu

Sponsors and Collaborators

University of California, San Francisco

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Veronica Yank, MD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT04428112
• Other Study ID Numbers: 18-25814; 5R01AG057855-02 ( U.S. NIH Grant/Contract ); 3R01AG057855-02S1 ( U.S. NIH Grant/Contract )
• First Posted: June 11, 2020
• Last Update Posted: August 8, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The data to be shared will be individual participant data that underlie the results reported in published article(s), after deidentification (e.g., text, tables, figures, and appendices). The additional and related documents that will be available are study protocol and data dictionary. The data will become available beginning within 3 months of article publication and ending 5 years following article publication.The access criteria for the data to be shared will include researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal including performance of meta-analysis of individual participant data. Proposals should be directed to veronica.yank@ucsf.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (Link to be included later).
• Supporting Materials: Study Protocol
• Time Frame: The data will become available beginning within 3 months of article publication and ending 5 years following article publication.
• Access Criteria: The access criteria for the data to be shared will include researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal including performance of meta-analysis of individual participant data. Proposals should be directed to veronica.yank@ucsf.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (Link to be included later).

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of California, San Francisco:

Caregiver; Caregiving

Additional relevant MeSH terms:

Parkinson Disease; Dementia; Alzheimer Disease; Dementia, Vascular; Lewy Body Disease; Aphasia, Primary Progressive; Pick Disease of the Brain; Frontotemporal Dementia; Dementia, Multi-Infarct; CADASIL; Stress, Psychological; Behavioral Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Infarction; Ischemia; Pathologic Processes; Necrosis; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases