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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03901456

Enrollment

Registered

2019-04-03

Start date

2019-09-01

Completion date

2022-05-24

Last updated

2023-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Dementia, Memory Loss

Keywords

Caregiving

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.

Interventions

BEHAVIORALCare 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.

BEHAVIORALUsual 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Intervention 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 \[randomized\].

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Caregiver Self-efficacy	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.

Secondary

Measure	Time frame	Description
Care to Plan Service Use	Phase II Baseline, 3-months, 6-months	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	Phase II Baseline, 3-months, 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.
Caregiver Distress: Role Captivity	Phase II Baseline, 3-months, 6-months	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)	Phase II Baseline, 3-months, 6-months	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.
Primary Subjective Stressors: Loss of Intimate Exchange	Phase II Baseline, 3-month, 6-month	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.

Other

Measure	Time frame	Description
Acceptability and Feasibility	Phase I at 1-month follow up	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.

Countries

United States

Participant flow

Pre-assignment details

Sixty-five participants consented to participate (during Phase I or Phase II of the project). Two participants did withdrew or were lost to follow up prior to initial survey completion. Data is reported for 63 participants completing the initial survey.

Participants by arm

Arm	Count
Treatment [Randomized] Participants in the treatment arm will receive the Care to Plan (CtP) intervention as part of Phase II. 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.	22
Control [Randomized] Participants randomized to a usual care control group as 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. 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.	21
Phase I: Treatment [Non-randomized] Participants enrolled in Phase I of the project to receive the intervention \[non-randomized, no comparison group\]. Care to Plan: Care to Plan (CtP) is an online care planning tool that provides 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.	20
Total	63

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	0	1	0
Overall Study	Withdrawal by Subject	0	0	1

Baseline characteristics

Characteristic	Treatment [Randomized]	Control [Randomized]	Phase I: Treatment [Non-randomized]	Total
Age, Continuous	52.33 years STANDARD_DEVIATION 16.54	63.38 years STANDARD_DEVIATION 11.77	66.68 years STANDARD_DEVIATION 11.43	63.24 years STANDARD_DEVIATION 12.42
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants	21 Participants	20 Participants	63 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	0 Participants	0 Participants	1 Participants
Race (NIH/OMB) Black or African American	3 Participants	4 Participants	5 Participants	12 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	18 Participants	17 Participants	15 Participants	50 Participants
Sex: Female, Male Female	17 Participants	15 Participants	18 Participants	50 Participants
Sex: Female, Male Male	5 Participants	6 Participants	2 Participants	13 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 22	0 / 21	0 / 20
other Total, other adverse events	7 / 22	4 / 21	0 / 20
serious Total, serious adverse events	1 / 22	0 / 21	0 / 20

Outcome results

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.

Time frame: Phase II Baseline, 3-months, 6-months