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Care to Plan: a Tailored Resource for Family Members of Persons With Dementia

Primary Purpose

Dementia, Alzheimer Disease, Memory Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care to Plan
Usual Care
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Caregiving

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Phase II [Randomized]: Treatment

Phase II [Randomized]: Control

Phase I [Non-randomized]: Treatment

Arm Description

Participants randomized to this treatment arm will receive the Care to Plan (CtP) intervention as a part of Phase II.

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.

Participants enrolled in Phase I of the project to receive the intervention [non-randomized; no comparison group].

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 - 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.
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.
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.
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.

Full Information

First Posted
March 28, 2019
Last Updated
June 1, 2023
Sponsor
University of Minnesota
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03901456
Brief Title
Care to Plan: a Tailored Resource for Family Members of Persons With Dementia
Official Title
Care to Plan: Preliminary Efficacy of a Tailored Resource for Family Members of Persons With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease, Memory Loss
Keywords
Caregiving

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Phase I of the study will include enrollment of 20 participants to test and refine the online tool [non-randomized]; in Phase II, we aim to enroll 100 participants to generate preliminary evaluation data [randomized].
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase II [Randomized]: Treatment
Arm Type
Experimental
Arm Description
Participants randomized to this treatment arm will receive the Care to Plan (CtP) intervention as a part of Phase II.
Arm Title
Phase II [Randomized]: Control
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Phase I [Non-randomized]: Treatment
Arm Type
Experimental
Arm Description
Participants enrolled in Phase I of the project to receive the intervention [non-randomized; no comparison group].
Intervention Type
Behavioral
Intervention Name(s)
Care to Plan
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Caregiver Self-efficacy
Description
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.
Time Frame
Phase II Baseline, 3-months, 6-months
Secondary Outcome Measure Information:
Title
Care to Plan Service Use
Description
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.
Time Frame
Phase II Baseline, 3-months, 6-months
Title
Phase II - Caregiver Distress: Role Overload
Description
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.
Time Frame
Phase II Baseline, 3-months, 6-months
Title
Primary Subjective Stressors: Loss of Intimate Exchange
Description
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.
Time Frame
Phase II Baseline, 3-month, 6-month
Title
Caregiver Distress: Role Captivity
Description
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.
Time Frame
Phase II Baseline, 3-months, 6-months
Title
Center for Epidemiological Studies Depression (CES-D)
Description
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.
Time Frame
Phase II Baseline, 3-months, 6-months
Other Pre-specified Outcome Measures:
Title
Acceptability and Feasibility
Description
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.
Time Frame
Phase I at 1-month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph E Gaugler, PhD
Organizational Affiliation
University of Minnestoa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
2276631
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.
Results Reference
background
PubMed Identifier
12028884
Citation
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.
Results Reference
background
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
Results Reference
background

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Care to Plan: a Tailored Resource for Family Members of Persons With Dementia

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