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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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|
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
Behavioral: Usual Care
Receive care as usual.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
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
|Contact: Joseph E Gaugler, PhDemail@example.com|
|United States, Minnesota|
|University of Minnesota||Recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Joseph Gaugler, PhD 612-626-2485 firstname.lastname@example.org|
|Principal Investigator:||Joseph E Gaugler, PhD||University of Minnestoa|