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Trial record 1 of 1 for:    NCT03901456
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Care to Plan: a Tailored Resource for Family Members of Persons With Dementia

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ClinicalTrials.gov Identifier: NCT03901456
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : September 22, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:

The present study will refine and conduct a preliminary efficacy evaluation of Care to Plan. Care to Plan is an online care planning tool that provides a succinct and clear overview of various types of dementia caregiver interventions, administers a brief validated assessment of risk, and generates individualized recommendations for dementia caregivers as well as resources that link users to a selected recommendation.

There remains a lack of individualized information that can directly meet the diverse needs of caregivers or their relatives with Alzheimer's disease or a related dementia (ADRD). This project will advance scientific knowledge, technical capability, and clinical practice as they pertain to ADRD management and caregiver support.


Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Memory Loss Behavioral: Care to Plan Behavioral: Usual Care Not Applicable

Detailed Description:
Given the well-documented health implications of dementia family caregiving, existing interventions are designed to modify the more challenging aspects of care for a relative with Alzheimer's disease or a related dementia (ADRD) in order to improve key outcomes. However, current research has yet to discern which caregivers are most likely to benefit from different types of interventions or services. There also remains a lack of individualized information that can directly meet the heterogeneous needs of caregivers or their relatives with ADRD. This project will advance scientific knowledge, technical capability, and clinical practice as they pertain to ADRD management and caregiver support. The research team has developed and tested the feasibility and utility of an online care planning tool prototype (called Care to Plan, or CtP) that provides a succinct and clear overview of various types of ADRD caregiver interventions, administers a brief validated assessment of risk, and generates individualized service recommendations for ADRD caregivers as well as resources that link users to a selected recommendation. The goal of CtP is to offer a more efficient, user-directed process to link ADRD caregivers to the services that may be most appropriate for them given their needs, the needs of their relatives, and other contextual characteristics. We will deploy and more fully evaluate CtP for family caregivers of persons with ADRD who seek services in Riverside Health System (RHS) in the state of Virginia. The Specific Aims are to: 1) Implement CtP for 20 family members of persons with ADRD in four RHS clinical sites (Phase I) over a 1-month period; and 2) Evaluate the preliminary efficacy and implementation of CtP (Phase II) via an embedded randomized controlled evaluation for 100 newly enrolled ADRD caregivers over a 6-month period. We anticipate that the CtP will serve as an innovative, low-cost tool that both families and long-term service and support providers can utilize to better meet the diverse needs of family caregivers of persons with ADRD in their communities.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase I of the study will include enrollment of 20 participants to test and refine the online tool; in Phase II, we aim to enroll 100 participants to generate preliminary evaluation data.
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Care to Plan: Preliminary Efficacy of a Tailored Resource for Family Members of Persons With Dementia
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arm Intervention/treatment
Experimental: Treatment
Participants in the treatment arm will receive the Care to Plan (CtP) intervention.
Behavioral: Care to Plan
Care to Plan (CtP) is an online care planning tool that provides a succinct and clear overview of various types of ADRD caregiver interventions, administers a brief validated assessment of risk, and generates individualized service recommendations for Alzheimer's disease and related dementia (ADRD) caregivers as well as resources that link users to a selected recommendation. Caregivers will complete the tool with the guidance of a CtP interventionist (Senior Care Navigator/Riverside Health System staff). The interventionist will discuss CtP recommendations with caregivers and help caregivers enroll in a recommended support service if so desired.

Active Comparator: Control
Usual care
Behavioral: Usual Care
Receive care as usual.




Primary Outcome Measures :
  1. Change in caregiver self-efficacy [ Time Frame: Baseline, 3-, and 6-months ]
    Eight-item survey developed by Fortinsky and colleagues. Item response scores range from 1 = "Very unconfident" to 5 = "Very confident." Item responses are summed; total score at each time point ranges from 8 (low self-efficacy) to 40 (high self-efficacy).

  2. Change in CtP service use [ Time Frame: Baseline, 3-, and 6-months ]
    Self-report of a CtP service over a 3 month period. Service types include Skills building, Problem solving, Take a break, Brain health, Support groups, Change your thinking, and High powered combinations.


Secondary Outcome Measures :
  1. Change in caregiver distress: burden [ Time Frame: Baseline, 3-, and 6-months ]
    4-item Zarit Burden Interview. Item responses range from 0 "never" to 4 "nearly always." Scores are summed.

  2. Change in caregiver distress: role captivity [ Time Frame: Baseline, 3-, and 6-months ]
    3-item scale assessing the involuntary aspects of the caregiving role. Item responses are averaged, with higher score representing greater role captivity.

  3. Change in caregiver distress: role overload [ Time Frame: Baseline, 3-, and 6-months ]
    A 3-item scale measuring caregivers' feelings of emotional fatigue. Item responses range from 1 = strongly disagree to 5 = strong agree. Item responses are averaged, with higher score representing greater role overload.

  4. Change in caregiver distress: depressive symptoms [ Time Frame: Baseline, 3-, and 6-months ]
    The 20-item Center for Epidemiological Studies Depression (CES-D) survey measure is used to assess respondents' depressive symptoms. Item responses range from 1 = "Rarely or none of the time (less than 1 day)" to 5 = "Most of the time (5-7 days)." The total CES-D score is summed, with a range of 20 (little to no depressive symptoms) to 100 (frequent depressive symptoms).

  5. Change in community-based/health service use [ Time Frame: Baseline, 3-, and 6-months ]
    Community-based service utilization of persons with ADRD will be assessed by asking family caregivers to identify (from a fixed list of options) fifteen different home and community-based services (HCBS). This is a "yes/no" checklist and is summed to create a total score: the higher the score, the more services used.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: The care recipient has received a provider diagnosis of Alzheimer's disease or a related dementia (ADRD); and 2) the caregiver is 21 years of age or older; 3) English-speaking; 4) self-identifies as someone who provides help to the person with ADRD because of their cognitive impairments; 5) the caregiver indicates a willingness to use Care to Plan (CtP); and 6) caregiver resides in one of 4 Riverside Health regions (based on zip code).

Exclusion Criteria: Those who do not meet the inclusion criteria above are not eligible. Additionally, those who endorse a history of a serious mental health disorder whose: a) symptoms have exacerbated in the last six months, and b) are not receiving steady, ongoing pharmacological or other treatment for these symptoms, will be excluded from the project.


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): NCT03901456


Contacts
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Contact: Joseph E Gaugler, PhD 612-626-2485 gaug0015@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Joseph Gaugler, PhD    612-626-2485    gaug0015@umn.edu   
Sponsors and Collaborators
University of Minnesota
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Joseph E Gaugler, PhD University of Minnestoa
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03901456    
Other Study ID Numbers: STUDY00005971
1R21AG060419-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Public access to the research data generated from this project will be offered via de-identified data files maintained by the investigators. All personal identifiers of family caregivers of persons with Alzheimer's disease or a related dementia (ADRD) participating in the study will be removed and replaced with random identification numbers prior to distributing data files. Dr. Gaugler plans to maintain all data from the proposed project on the secure School of Public Health shared server folder for 7 years following study completion. Potential external investigators will be asked to complete a data use agreement and a recommended citation to these materials will be provided. Dr. Gaugler will oversee the distribution of public data during the course of the funding period and for an indefinite time thereafter.

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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 Minnesota:
Caregiving
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Memory Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations