Trial Outcomes & Findings for Care to Plan: a Tailored Resource for Family Members of Persons With Dementia (NCT NCT03901456)
NCT ID: NCT03901456
Last Updated: 2023-06-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Phase II Baseline, 3-months, 6-months
Results posted on
2023-06-02
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Phase II: 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.
|
Phase II: 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
21
|
|
Overall Study
COMPLETED
|
20
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Phase II: 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.
|
Phase II: 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.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Care to Plan: a Tailored Resource for Family Members of Persons With Dementia
Baseline characteristics by cohort
| Measure |
Treatment [Randomized]
n=22 Participants
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.
|
Control [Randomized]
n=21 Participants
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.
|
Phase I: Treatment [Non-randomized]
n=20 Participants
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.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.33 years
STANDARD_DEVIATION 16.54 • n=5 Participants
|
63.38 years
STANDARD_DEVIATION 11.77 • n=7 Participants
|
66.68 years
STANDARD_DEVIATION 11.43 • n=5 Participants
|
63.24 years
STANDARD_DEVIATION 12.42 • n=4 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Phase II Baseline, 3-months, 6-monthsPopulation: Outcome reported for Phase II only; number analyzed varies by treatment arm and timepoint (due to missing data and/or withdrawal).
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.
Outcome measures
| Measure |
Phase II [Randomized]: Treatment
n=22 Participants
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.
|
Phase II [Randomized]: Control
n=21 Participants
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.
|
|---|---|---|
|
Caregiver Self-efficacy
Baseline [Phase II]
|
3.62 scores on a scale
Standard Deviation .85
|
3.36 scores on a scale
Standard Deviation .74
|
|
Caregiver Self-efficacy
3-months [Phase II]
|
3.84 scores on a scale
Standard Deviation .96
|
3.57 scores on a scale
Standard Deviation .88
|
|
Caregiver Self-efficacy
6-months [Phase II]
|
3.58 scores on a scale
Standard Deviation .73
|
3.55 scores on a scale
Standard Deviation .70
|
SECONDARY outcome
Timeframe: Phase II Baseline, 3-months, 6-monthsPopulation: Outcome reported for Phase II only; number analyzed varies by treatment arm and timepoint (due to missing data and/or withdrawal).
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.
Outcome measures
| Measure |
Phase II [Randomized]: Treatment
n=22 Participants
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.
|
Phase II [Randomized]: Control
n=21 Participants
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.
|
|---|---|---|
|
Care to Plan Service Use
Baseline [Phase II]
|
2.69 services
Standard Deviation 1.25
|
2.62 services
Standard Deviation 1.32
|
|
Care to Plan Service Use
3-month [Phase II]
|
3.00 services
Standard Deviation 0.88
|
2.56 services
Standard Deviation 1.69
|
|
Care to Plan Service Use
6-month [Phase II]
|
2.31 services
Standard Deviation 1.20
|
2.25 services
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: Phase II Baseline, 3-months, 6-monthsPopulation: Outcome reported for Phase II only; number analyzed varies by treatment arm and timepoint (due to missing data and/or withdrawal).
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.
Outcome measures
| Measure |
Phase II [Randomized]: Treatment
n=22 Participants
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.
|
Phase II [Randomized]: Control
n=21 Participants
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.
|
|---|---|---|
|
Phase II - Caregiver Distress: Role Overload
Baseline [Phase II]
|
3.23 score on a scale (mean)
Standard Deviation 1.28
|
3.71 score on a scale (mean)
Standard Deviation 1.05
|
|
Phase II - Caregiver Distress: Role Overload
3-month [Phase II]
|
3.18 score on a scale (mean)
Standard Deviation 1.14
|
3.56 score on a scale (mean)
Standard Deviation 1.00
|
|
Phase II - Caregiver Distress: Role Overload
6-month [Phase II]
|
3.15 score on a scale (mean)
Standard Deviation 1.10
|
3.77 score on a scale (mean)
Standard Deviation .85
|
SECONDARY outcome
Timeframe: Phase II Baseline, 3-month, 6-monthPopulation: Outcome reported for Phase II only; number analyzed varies by treatment arm and timepoint (due to missing data and/or withdrawal).
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.
Outcome measures
| Measure |
Phase II [Randomized]: Treatment
n=22 Participants
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.
|
Phase II [Randomized]: Control
n=21 Participants
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.
|
|---|---|---|
|
Primary Subjective Stressors: Loss of Intimate Exchange
Baseline [Phase II]
|
3.30 score on a scale (mean)
Standard Deviation .92
|
2.86 score on a scale (mean)
Standard Deviation .93
|
|
Primary Subjective Stressors: Loss of Intimate Exchange
3-month [Phase II]
|
3.25 score on a scale (mean)
Standard Deviation .97
|
2.98 score on a scale (mean)
Standard Deviation .86
|
|
Primary Subjective Stressors: Loss of Intimate Exchange
6-month [Phase II]
|
3.35 score on a scale (mean)
Standard Deviation .82
|
3.13 score on a scale (mean)
Standard Deviation .82
|
SECONDARY outcome
Timeframe: Phase II Baseline, 3-months, 6-monthsPopulation: Outcome reported for Phase II only; number analyzed varies by treatment arm and timepoint (due to missing data and/or withdrawal).
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.
Outcome measures
| Measure |
Phase II [Randomized]: Treatment
n=22 Participants
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.
|
Phase II [Randomized]: Control
n=21 Participants
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.
|
|---|---|---|
|
Caregiver Distress: Role Captivity
Baseline [Phase II]
|
1.97 score on a scale (mean)
Standard Deviation .93
|
2.27 score on a scale (mean)
Standard Deviation .83
|
|
Caregiver Distress: Role Captivity
3-month [Phase II]
|
1.98 score on a scale (mean)
Standard Deviation 1.03
|
2.17 score on a scale (mean)
Standard Deviation .77
|
|
Caregiver Distress: Role Captivity
6-month [Phase II]
|
1.94 score on a scale (mean)
Standard Deviation .95
|
2.29 score on a scale (mean)
Standard Deviation 1.03
|
SECONDARY outcome
Timeframe: Phase II Baseline, 3-months, 6-monthsPopulation: Outcome reported for Phase II only; number analyzed varies by treatment arm and timepoint (due to missing data and/or withdrawal).
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.
Outcome measures
| Measure |
Phase II [Randomized]: Treatment
n=22 Participants
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.
|
Phase II [Randomized]: Control
n=21 Participants
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.
|
|---|---|---|
|
Center for Epidemiological Studies Depression (CES-D)
Baseline [Phase II]
|
15.73 score on a scale
Standard Deviation 7.11
|
19.10 score on a scale
Standard Deviation 7.52
|
|
Center for Epidemiological Studies Depression (CES-D)
3-month [Phase II]
|
18.47 score on a scale
Standard Deviation 8.39
|
21.50 score on a scale
Standard Deviation 7.80
|
|
Center for Epidemiological Studies Depression (CES-D)
6-month [Phase II]
|
18.19 score on a scale
Standard Deviation 7.28
|
20.50 score on a scale
Standard Deviation 7.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Phase I at 1-month follow upPopulation: Phase I \[Non-randomized\]: All phase I participants completed this set of questions at 1-month.
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.
Outcome measures
| Measure |
Phase II [Randomized]: Treatment
n=20 Participants
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.
|
Phase II [Randomized]: Control
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.
|
|---|---|---|
|
Acceptability and Feasibility
|
4.22 score on a scale (mean)
Standard Deviation 0.69
|
—
|
Adverse Events
Phase II [Randomized]: Control
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Phase II [Randomized]: Treatment
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase I [Non-randomized]: Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase II [Randomized]: Control
n=21 participants at risk
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.
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.
|
Phase II [Randomized]: Treatment
n=22 participants at risk
Participants randomized to this treatment arm will receive the Care to Plan (CtP) intervention as a 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.
|
Phase I [Non-randomized]: Treatment
n=20 participants at risk
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 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.
|
|---|---|---|---|
|
Renal and urinary disorders
UTI
|
0.00%
0/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
4.5%
1/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
Other adverse events
| Measure |
Phase II [Randomized]: Control
n=21 participants at risk
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.
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.
|
Phase II [Randomized]: Treatment
n=22 participants at risk
Participants randomized to this treatment arm will receive the Care to Plan (CtP) intervention as a 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.
|
Phase I [Non-randomized]: Treatment
n=20 participants at risk
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 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.
|
|---|---|---|---|
|
Infections and infestations
COVID
|
0.00%
0/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
9.1%
2/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
|
Psychiatric disorders
Initiate Anxiety Medication
|
0.00%
0/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
4.5%
1/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
|
Endocrine disorders
Initiate Thyroid Medication
|
0.00%
0/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
4.5%
1/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
|
Musculoskeletal and connective tissue disorders
Hip issue [unspecified]
|
4.8%
1/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
|
Cardiac disorders
Hypertension
|
4.8%
1/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.8%
1/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
|
General disorders
Unknown/not specified medical concern
|
4.8%
1/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
|
Eye disorders
Eye surgery
|
0.00%
0/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
4.5%
1/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
|
Musculoskeletal and connective tissue disorders
Multiple falls during study
|
0.00%
0/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
4.5%
1/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
|
General disorders
Vulnerable adult report
|
0.00%
0/21 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
4.5%
1/22 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
0.00%
0/20 • Adverse events were documented during study enrollment (following consent through final data collection). Phase I participants did not have any systematic assessment, but were enrolled for a period of about 1 month. A systematic assessment item was implemented during phase II follow up; participants were enrolled for about 6 months.
New or worsening health problems that caused the participant to be unable to perform daily routine (i.e. not go to work or volunteer), seek medical care (i.e. go see your doctor, go to the ER or hospital), or take a new medication \[Phase I: Non-systematic assessment; Phase II: implemented systematic assessment\]
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place