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Completed

NCT Number: NCT04428112

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 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 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).

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Key information

Conditions

Depression AIDS Dementia Complex Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Basal Ganglia Diseases Behavior Behavioral Symptoms Blood-Borne Infections Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Infarction Cerebrovascular Disorders Communicable Diseases 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 Frontotemporal Dementia Frontotemporal Lobar Degeneration Genital Diseases HIV Infections Health Behavior Health Care Utilization Immune System Diseases Immunologic Deficiency Syndromes Infarction Infections Intracranial Arterial Diseases Intracranial Arteriosclerosis Ischemia Lentivirus Infections Leukoencephalopathies Lewy Body Disease Loneliness Mental Disorders Mixed Dementias Movement Disorders Necrosis Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Pick Disease of the Brain RNA Virus Infections Retroviridae Infections Self Efficacy Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Social Behavior Social Isolation Stress, Psychological Stroke Synucleinopathies Tauopathies Treatment Adherence and Compliance Urogenital Diseases Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Building Better Caregivers workshop

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Personal Health Questionnaire Depression (PHQ-8) Scale Score

    Time frame: 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.

  2. Visual Numeric Stress Scale

    Time frame: 12 months

    A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.

Secondary outcomes

  1. Personal Health Questionnaire Depression (PHQ-8) Scale Score

    Time frame: 6 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.

  2. Visual Numeric Stress Scale Score

    Time frame: 6 months

    A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.

  3. Short Caregiver Self-Efficacy Scale Score

    Time frame: 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.

  4. Zarit Burden Interview-12 (ZBI-12) Scale Score

    Time frame: 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.

  5. Caregiver Self-rated General Health Score

    Time frame: 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.

  6. UCLA Loneliness Scale Score

    Time frame: 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.

  7. Lubben Social Isolation Scale Score

    Time frame: 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.

  8. Caregiver Health Care Utilization

    Time frame: 12 months

    3-items measuring days of 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. Scores range from 0-180.

  9. Person With Dementia General Health Score as Reported by Caregiver

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related Dementias

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 11, 2020
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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