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NCT04428112 · ClinicalTrials.gov registry record · NA
Rural Dementia Caregiver Project
A NA study of Depression and Dementia, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 418
- Enrollment target
- 1
- Study location
NCT04428112: Completed NA study of Depression and Dementia, sponsored by University of California, San Francisco.
NCT04428112 is a NA study of Depression and Dementia that has completed, run by University of California, San Francisco. The registered enrollment target is 418 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04428112, a NA study of Depression and Dementia, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 418 participants
- Enrollment target
- 1
- Study location
Study Summary
Rural caregivers face challenges of geographic isolation and lower 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 depressive symptoms. The investigators hypothesize that stress scores and depressive 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
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Attention Control
- BEHAVIORAL Building Better Caregivers Workshop
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2020-06-05 |
| Est. Completion | 2023-10-16 |
| Phase | NA |
What the finished NCT04428112 record still lists
NCT04428112 is an interventional study that assigns participants to a tested intervention. The registered 418 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (47% lower).
The record links to 10 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Attention Control is the first listed.
NCT04428112 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04428112 about?
NCT04428112 is a clinical study titled "Rural Dementia Caregiver Project". Rural caregivers face challenges of geographic isolation and lower 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 f...
What is the current status of trial NCT04428112?
This trial is currently completed. It is a NA study. The enrollment target is 418 participants. The study started on 2020-06-05. Estimated completion is 2023-10-16.
What conditions does trial NCT04428112 study?
This clinical trial studies the following conditions: Depression, Dementia, Stress, Psychological, Loneliness, Self Efficacy.
What interventions are being tested in trial NCT04428112?
The interventions under investigation include: Attention Control (BEHAVIORAL), Building Better Caregivers Workshop (BEHAVIORAL).
Who is sponsoring clinical trial NCT04428112?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04428112 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04428112's enrollment target sits among peer trials
418 100th of 679 higher than 580 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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