- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04428112
Rural Dementia Caregiver Project
Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related Dementias
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).
Study Overview
Status
Conditions
- Depression
- Stress, Psychological
- Dementia
- Dementia, Vascular
- Loneliness
- Self Efficacy
- Dementia, Mixed
- Health Care Utilization
- Dementia Alzheimers
- Dementia of Alzheimer Type
- Social Isolation
- Dementia, Multi-Infarct
- Dementia, Lewy Body
- Dementia in Parkinsons Disease
- Dementia Frontal
- Dementia Frontotemporal
- Dementia, HIV
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Veronica Yank, MD
- Phone Number: 415-476-9654
- Email: veronica.yank@ucsf.edu
Study Contact Backup
- Name: Jasmine Santoyo-Olsson, MS
- Phone Number: 1-833-634-0603
- Email: jasmine.santoyo-olsson@ucsf.edu
Study Locations
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California
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San Francisco, California, United States, 94118
- University of California, San Francisco
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 12 months
|
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.
|
Baseline and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 12 months
|
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.
|
Baseline and 12 months
|
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.
|
Baseline and 12 months
|
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.
|
Baseline and 12 months
|
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.
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Baseline and 12 months
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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.
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Baseline and 12 months
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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.
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Baseline and 12 months
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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.
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Baseline and 12 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline and 12 months
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Change in exercise behavior scale score from baseline to 12 months
Time Frame: Baseline and 12 months
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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.
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Baseline and 12 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Veronica Yank, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Genetic Diseases, Inborn
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Brain Ischemia
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Tauopathies
- Infarction
- Stroke
- Brain Infarction
- Language Disorders
- Communication Disorders
- Cerebral Arterial Diseases
- Intracranial Arterial Diseases
- Cerebral Small Vessel Diseases
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Aphasia
- Cerebral Infarction
- Parkinson Disease
- Stress, Psychological
- Dementia
- Alzheimer Disease
- Lewy Body Disease
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Dementia, Vascular
- CADASIL
- Dementia, Multi-Infarct
Other Study ID Numbers
- 18-25814
- 5R01AG057855-02 (U.S. NIH Grant/Contract)
- 3R01AG057855-02S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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