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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03901456
Other study ID # STUDY00005971
Secondary ID 1R21AG060419-01A
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date May 24, 2022

Study information

Verified date June 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date May 24, 2022
Est. primary completion date May 24, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


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.
Usual Care
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.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Other Acceptability and Feasibility 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. Phase I at 1-month follow up
Primary Caregiver Self-efficacy 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. Phase II Baseline, 3-months, 6-months
Secondary Care to Plan Service Use 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. Phase II Baseline, 3-months, 6-months
Secondary Phase II - Caregiver Distress: Role Overload 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. Phase II Baseline, 3-months, 6-months
Secondary Primary Subjective Stressors: Loss of Intimate Exchange 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. Phase II Baseline, 3-month, 6-month
Secondary Caregiver Distress: Role Captivity 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. Phase II Baseline, 3-months, 6-months
Secondary Center for Epidemiological Studies Depression (CES-D) 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. Phase II Baseline, 3-months, 6-months
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