- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03901456
Care to Plan: a Tailored Resource for Family Members of Persons With Dementia
Care to Plan: Preliminary Efficacy of a Tailored Resource for Family Members of Persons With Dementia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase II [Randomized]: Treatment
Participants randomized to this treatment arm will receive the Care to Plan (CtP) intervention as a part of Phase II.
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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: Phase II [Randomized]: Control
Participants randomized to a usual care control group as a part of Phase II. Note: If eligible, participants in this control group will be asked if they are interested in enrolling in a similar, additional feature of the study to test the Care to Plan tool following the initial 6-month study. |
Receive care as usual. Note: If eligible, participants in this control group will be asked if they are interested in enrolling in a similar, additional feature of the study to test the Care to Plan tool following the initial 6-month study. |
Experimental: Phase I [Non-randomized]: Treatment
Participants enrolled in Phase I of the project to receive the intervention [non-randomized; no comparison group].
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver Self-efficacy
Time Frame: Phase II Baseline, 3-months, 6-months
|
Eight-item survey developed by Fortinsky and colleagues.
Responses for each item range from 1 (Very unconfident) to 5 (Very confident), with higher scores indicating greater self-efficacy.
The 8-item responses are averaged.
Mean of participant scores is reported.
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Phase II Baseline, 3-months, 6-months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Care to Plan Service Use
Time Frame: Phase II Baseline, 3-months, 6-months
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This author-developed scale is a self-report of a various services used over a 3 month period.
Service types include Skills building, Problem solving, Take a break, Brain health, Support groups, Change your thinking, High powered combinations, and Other.
The total number of services used are summed (ranging 0 to 8, with higher numbers indicating greater service use).
The average of participant responses is reported.
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Phase II Baseline, 3-months, 6-months
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Phase II - Caregiver Distress: Role Overload
Time Frame: Phase II Baseline, 3-months, 6-months
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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.
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Phase II Baseline, 3-months, 6-months
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Primary Subjective Stressors: Loss of Intimate Exchange
Time Frame: Phase II Baseline, 3-month, 6-month
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3-items addressing relationship with relative.
Responses include Very much (4), Somewhat (3), Just a little (2), Not at all (1), with higher scores indicating greater loss.
Mean of the 3 items is analyzed.
Overall mean of participants is reported.
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Phase II Baseline, 3-month, 6-month
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Caregiver Distress: Role Captivity
Time Frame: Phase II Baseline, 3-months, 6-months
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3-items assessing the involuntary aspects of the caregiving role.
Responses for each item include: Very much (4), Somewhat (3), Just a little (2), Not at all (1), with higher score representing greater role captivity.
Mean of the 3 items is analyzed.
Overall mean of participants is reported.
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Phase II Baseline, 3-months, 6-months
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Center for Epidemiological Studies Depression (CES-D)
Time Frame: Phase II Baseline, 3-months, 6-months
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The 20-item Center for Epidemiological Studies Depression (CES-D) survey measure is used to assess respondents' depressive symptoms.
Each of the 20 items is scored from 0 = Rarely or none of the time (less than 1 day) to 3 = Most of the time (5-7 days), with 4 items reverse coded.
The total CES-D score is summed (ranging 0-60), with higher scores representing more frequent depressive symptoms.
Results are reported as a mean of participant scores.
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Phase II Baseline, 3-months, 6-months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability and Feasibility
Time Frame: Phase I at 1-month follow up
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This is an author-developed 21-item scale assessing the acceptability and feasibility of the intervention.
Response options include Strongly Disagree (1), Disagree (2), Neutral (3), Agree (4), and Strongly Agree (5), or not applicable; 4 items are reverse coded.
Higher scores indicate greater acceptability and feasibility of the tool.
The summary score represents a mean of the 21-items.
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Phase I at 1-month follow up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joseph E Gaugler, PhD, University of Minnestoa
Publications and helpful links
General Publications
- Fortinsky RH, Kercher K, Burant CJ. Measurement and correlates of family caregiver self-efficacy for managing dementia. Aging Ment Health. 2002 May;6(2):153-60. doi: 10.1080/13607860220126763.
- Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of concepts and their measures. Gerontologist. 1990 Oct;30(5):583-94. doi: 10.1093/geront/30.5.583.
- Radloff, L. S. (1977). The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement, 1(3), 385-401. https://doi.org/10.1177/014662167700100306
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00005971
- 1R21AG060419-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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