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Rural Dementia Caregiver Project

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04428112
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of California, San Francisco

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: 320 in the intervention (workshop) group and 320 in 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

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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 : June 2022
Estimated Study Completion Date : May 2023


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.




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.



Information from the National Library of Medicine

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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)
  • Care partner living in a skilled nursing or similar facility

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04428112


Contacts
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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
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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
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Principal Investigator: Veronica Yank, MD University of California, San Francisco
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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    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
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).

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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:
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Parkinson Disease
Dementia
Alzheimer Disease
Dementia, Vascular
Lewy Body Disease
Dementia, Multi-Infarct
CADASIL
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Stress, Psychological
Behavioral Symptoms
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases