Trial Outcomes & Findings for Developing and Testing the Enhancing Active Caregiver Training (EnACT) Intervention for Dementia Family Caregivers (NCT NCT04920006)

NCT ID: NCT04920006

Last Updated: 2026-05-20

Results Overview

This outcome will be measured using the Revised Caregiving Appraisal Scale (5-point Likert scale) which asks ADRD caregivers to assess five subscales. This subscale focuses on Mastery with a minimum value (worse outcome) of 1 and a maximum value (better outcome) of 5.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Results posted on

2026-05-20

Participant Flow

A two-step recruitment process was used: 1) flyers, emails, and in-person presentations were provided to invite individuals participating in caregiver support groups through the state chapter of the Alzheimer's Association and the Utah Caregiver Support Program; 2) the Time for Living and Caring (TLC) Intervention study served as a referral source. Recruitment took about four months. Those interested were screened via phone. If eligible they were invited to enroll in the study.

Following enrollment, each participant completed the baseline survey and completed a technology check to make sure they could access the intervention. No significant events occurred between enrollment and assignment to intervention or wait-list control groups.

Participant milestones

Participant milestones
Measure
Immediate Intervention
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Overall Study
STARTED
15
15
Overall Study
COMPLETED
15
14
Overall Study
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Immediate Intervention
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Overall Study
Withdrawal by Subject
0
1

Baseline Characteristics

Developing and Testing the Enhancing Active Caregiver Training (EnACT) Intervention for Dementia Family Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Total
n=30 Participants
Total of all reporting groups
Age, Continuous
62 Years
STANDARD_DEVIATION 12.15 • n=30 Participants
57 Years
STANDARD_DEVIATION 14.24 • n=30 Participants
60 Years
STANDARD_DEVIATION 13.24 • n=60 Participants
Sex: Female, Male
Female
12 Participants
n=30 Participants
13 Participants
n=30 Participants
25 Participants
n=60 Participants
Sex: Female, Male
Male
3 Participants
n=30 Participants
2 Participants
n=30 Participants
5 Participants
n=60 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=30 Participants
3 Participants
n=30 Participants
3 Participants
n=60 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=30 Participants
12 Participants
n=30 Participants
26 Participants
n=60 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants
n=30 Participants
0 Participants
n=30 Participants
1 Participants
n=60 Participants
Race/Ethnicity, Customized
American Indian/Alaskan Native
1 Participants
n=30 Participants
0 Participants
n=30 Participants
1 Participants
n=60 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Race/Ethnicity, Customized
Black or African American
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Race/Ethnicity, Customized
Multiracial
0 Participants
n=30 Participants
2 Participants
n=30 Participants
2 Participants
n=60 Participants
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Race/Ethnicity, Customized
White
13 Participants
n=30 Participants
13 Participants
n=30 Participants
26 Participants
n=60 Participants
Race/Ethnicity, Customized
Other
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Race/Ethnicity, Customized
Prefer not to answer
1 Participants
n=30 Participants
0 Participants
n=30 Participants
1 Participants
n=60 Participants
Employment
Working full-time
3 Participants
n=30 Participants
4 Participants
n=30 Participants
7 Participants
n=60 Participants
Employment
Working part-time
2 Participants
n=30 Participants
1 Participants
n=30 Participants
3 Participants
n=60 Participants
Employment
Not employed
2 Participants
n=30 Participants
3 Participants
n=30 Participants
5 Participants
n=60 Participants
Employment
Retired
8 Participants
n=30 Participants
7 Participants
n=30 Participants
15 Participants
n=60 Participants
Employment
Prefer not to answer
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Education
Did not graduate from high school
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Education
High school graduate
3 Participants
n=30 Participants
4 Participants
n=30 Participants
7 Participants
n=60 Participants
Education
Bachelors degree
9 Participants
n=30 Participants
6 Participants
n=30 Participants
15 Participants
n=60 Participants
Education
Masters degree
1 Participants
n=30 Participants
5 Participants
n=30 Participants
6 Participants
n=60 Participants
Education
Doctorate
2 Participants
n=30 Participants
0 Participants
n=30 Participants
2 Participants
n=60 Participants
Education
Post-graduate degree
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Education
Prefer not to answer
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Relationship Status
Single, never been married
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Relationship Status
Separated
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Relationship Status
Divorced
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Relationship Status
Married
15 Participants
n=30 Participants
15 Participants
n=30 Participants
30 Participants
n=60 Participants
Relationship Status
Living with Partner
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Relationship Status
Widow or widower
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Relationship Status
Other
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Relationship Status
Prefer not to answer
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Who do you provide the majority of care for?
Spouse or partner
11 Participants
n=30 Participants
12 Participants
n=30 Participants
23 Participants
n=60 Participants
Who do you provide the majority of care for?
Parent
4 Participants
n=30 Participants
1 Participants
n=30 Participants
5 Participants
n=60 Participants
Who do you provide the majority of care for?
Grandparent
0 Participants
n=30 Participants
1 Participants
n=30 Participants
1 Participants
n=60 Participants
Who do you provide the majority of care for?
Friend
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Who do you provide the majority of care for?
Sibling
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Who do you provide the majority of care for?
Other
0 Participants
n=30 Participants
1 Participants
n=30 Participants
1 Participants
n=60 Participants
Who do you provide the majority of care for?
Prefer not to answer
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Sex: Care Partner
Female
8 Participants
n=30 Participants
5 Participants
n=30 Participants
13 Participants
n=60 Participants
Sex: Care Partner
Male
7 Participants
n=30 Participants
10 Participants
n=30 Participants
17 Participants
n=60 Participants
Sex: Care Partner
Other
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Sex: Care Partner
Prefer not to answer
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Age: Care Partner
73 Years
STANDARD_DEVIATION 11.23 • n=30 Participants
67 Years
STANDARD_DEVIATION 12.83 • n=30 Participants
70 Years
STANDARD_DEVIATION 12.15 • n=60 Participants
Length providing care
Less than 1 year
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Length providing care
1-2 years
6 Participants
n=30 Participants
5 Participants
n=30 Participants
11 Participants
n=60 Participants
Length providing care
3-5 years
8 Participants
n=30 Participants
7 Participants
n=30 Participants
15 Participants
n=60 Participants
Length providing care
6-10 years
0 Participants
n=30 Participants
2 Participants
n=30 Participants
2 Participants
n=60 Participants
Length providing care
more than 10 years
1 Participants
n=30 Participants
1 Participants
n=30 Participants
2 Participants
n=60 Participants
Length providing care
Other
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Length providing care
Prefer not to answer
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
caregiver training or support
Yes
13 Participants
n=30 Participants
8 Participants
n=30 Participants
21 Participants
n=60 Participants
caregiver training or support
No
2 Participants
n=30 Participants
7 Participants
n=30 Participants
9 Participants
n=60 Participants
caregiver training or support
Prefer not to answer
0 Participants
n=30 Participants
0 Participants
n=30 Participants
0 Participants
n=60 Participants
Household income
Less than $10,000
0 Participants
n=30 Participants
1 Participants
n=30 Participants
1 Participants
n=60 Participants
Household income
$25,001 - $40,000
0 Participants
n=30 Participants
3 Participants
n=30 Participants
3 Participants
n=60 Participants
Household income
$40,001 - $50,000
1 Participants
n=30 Participants
0 Participants
n=30 Participants
1 Participants
n=60 Participants
Household income
$50,001 - $60,000
2 Participants
n=30 Participants
0 Participants
n=30 Participants
2 Participants
n=60 Participants
Household income
$60,001 - $75,000
0 Participants
n=30 Participants
5 Participants
n=30 Participants
5 Participants
n=60 Participants
Household income
$75,001 - $100,000
2 Participants
n=30 Participants
1 Participants
n=30 Participants
3 Participants
n=60 Participants
Household income
$100,001 - $125,000
1 Participants
n=30 Participants
0 Participants
n=30 Participants
1 Participants
n=60 Participants
Household income
$125,001 or more
5 Participants
n=30 Participants
1 Participants
n=30 Participants
6 Participants
n=60 Participants
Household income
Prefer not to answer
4 Participants
n=30 Participants
4 Participants
n=30 Participants
8 Participants
n=60 Participants

PRIMARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

The Survey of Imagined Interactions measures outcomes of imagining interactions to prepare for the future. The Specificity subscale measures the level of detail within imagined interactions. It is a four-item subscale, where each question uses a 7-point Likert scale to gather data, with 1 being the lowest score for each item and 7 the highest. When totaled across items, this scale has a minimum value (less specificity) of 4 and a maximum value (more specificity) of 28.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Imagined Interactions: Specificity
Baseline (T1)
16.87 Scores on a scale
Standard Deviation 2.29
16.33 Scores on a scale
Standard Deviation 2.47
Imagined Interactions: Specificity
Week 2 (T2)
16.49 Scores on a scale
Standard Deviation 3.70
16.20 Scores on a scale
Standard Deviation 2.51
Imagined Interactions: Specificity
Week 5 (T3)
15.87 Scores on a scale
Standard Deviation 3.11
16.64 Scores on a scale
Standard Deviation 2.21
Imagined Interactions: Specificity
Week 8 (T4)
16.53 Scores on a scale
Standard Deviation 2.53
15.64 Scores on a scale
Standard Deviation 2.27
Imagined Interactions: Specificity
Week 11 (T5)
16.13 Scores on a scale
Standard Deviation 3.00
15.43 Scores on a scale
Standard Deviation 2.31
Imagined Interactions: Specificity
Week 14 (T6)
17.21 Scores on a scale
Standard Deviation 3.40
15.50 Scores on a scale
Standard Deviation 2.24

PRIMARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

The Survey of Imagined Interactions measures outcomes of imagining interactions to prepare for the future. The Proactivity subscale measures the level of advanced preparation for an event using imagined interactions. It is a four-item subscale, where each question uses a 7-point Likert scale to gather data, with 1 being the lowest score for each item and 7 the highest. When totaled across items, this scale has a minimum value (less proactivity) of 4 and a maximum value (more proactivity) of 28.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Imagined Interactions: Proactivity
Week 2 (T2)
17.73 Scores on a scale
Standard Deviation 4.62
18.73 Scores on a scale
Standard Deviation 3.97
Imagined Interactions: Proactivity
Week 5 (T3)
17.73 Scores on a scale
Standard Deviation 4.85
19.21 Scores on a scale
Standard Deviation 4.37
Imagined Interactions: Proactivity
Week 8 (T4)
18.07 Scores on a scale
Standard Deviation 4.40
18.07 Scores on a scale
Standard Deviation 4.43
Imagined Interactions: Proactivity
Week 11 (T5)
16.87 Scores on a scale
Standard Deviation 6.90
16.07 Scores on a scale
Standard Deviation 5.78
Imagined Interactions: Proactivity
Baseline (T1)
18.40 Scores on a scale
Standard Deviation 3.16
17.20 Scores on a scale
Standard Deviation 5.37
Imagined Interactions: Proactivity
Week 14 (T6)
17.53 Scores on a scale
Standard Deviation 5.53
16.93 Scores on a scale
Standard Deviation 5.40

PRIMARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

The Survey of Imagined Interactions measures outcomes of imagining interactions to prepare for the future. The Discrepancy subscale measures the level of difference between what one imagines and reality. In preparing for the future, the goal is to reduce discrepancy. This is a six-item subscale, where each question uses a 7-point Likert scale to gather data, with 1 being the lowest score for each item and 7 the highest. We reverse coded items so that a higher score is better and aligns with the other subscales of Imagined Interactions. When totaled across items, this scale has a minimum value (more discrepancy) of 6 and a maximum value (less discrepancy) of 42.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Imagined Interactions: Discrepancy
Baseline (T1)
21.40 Scores on a scale
Standard Deviation 2.35
21.20 Scores on a scale
Standard Deviation 4.23
Imagined Interactions: Discrepancy
Week 8 (T4)
20.73 Scores on a scale
Standard Deviation 3.90
23.36 Scores on a scale
Standard Deviation 5.53
Imagined Interactions: Discrepancy
Week 11 (T5)
20.87 Scores on a scale
Standard Deviation 3.68
23.62 Scores on a scale
Standard Deviation 6.95
Imagined Interactions: Discrepancy
Week 14 (T6)
19.72 Scores on a scale
Standard Deviation 4.54
23.57 Scores on a scale
Standard Deviation 5.46
Imagined Interactions: Discrepancy
Week 2 (T2)
20.60 Scores on a scale
Standard Deviation 2.41
21.93 Scores on a scale
Standard Deviation 4.48
Imagined Interactions: Discrepancy
Week 5 (T3)
19.73 Scores on a scale
Standard Deviation 3.47
23.86 Scores on a scale
Standard Deviation 6.10

PRIMARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

Capacity to Adapt is measured using the Resilience Scale. This scale measures one's ability to adapt specific to constructs of meaning, self-confidence, perseverance, serenity, and loneliness. This scale has 25 items that use a 7-point Likert scale for measurement, with 1 being the lowest score for each item and 7 the highest. The minimum total value of the scale is 25 (worse resilience) and maximum potential value of 175 (better resilience).

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Capacity to Adapt
Baseline (T1)
141.33 Scores on a scale
Standard Deviation 11.78
143.13 Scores on a scale
Standard Deviation 14.97
Capacity to Adapt
Week 2 (T2)
140.40 Scores on a scale
Standard Deviation 12.92
142.80 Scores on a scale
Standard Deviation 14.51
Capacity to Adapt
Week 5 (T3)
142.80 Scores on a scale
Standard Deviation 13.09
138.64 Scores on a scale
Standard Deviation 17.04
Capacity to Adapt
Week 8 (T4)
140.73 Scores on a scale
Standard Deviation 13.35
144.00 Scores on a scale
Standard Deviation 18.90
Capacity to Adapt
Week 11 (T5)
141.33 Scores on a scale
Standard Deviation 14.37
142.64 Scores on a scale
Standard Deviation 16.22
Capacity to Adapt
Week 14 (T6)
143.00 Scores on a scale
Standard Deviation 12.82
145.57 Scores on a scale
Standard Deviation 16.59

PRIMARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

This outcome will be measured using the Revised Caregiving Appraisal Scale (5-point Likert scale) which asks ADRD caregivers to assess five subscales. This subscale focuses on Burden with a minimum value (better outcome) of 1 and a maximum value (worse outcome) of 5.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Caregiver Capacity to Appraise Demands: Caregiving Burden Subscale
Baseline (T1)
3.24 Scores on a scale
Standard Deviation 0.77
3.50 Scores on a scale
Standard Deviation 0.68
Caregiver Capacity to Appraise Demands: Caregiving Burden Subscale
Week 2 (T2)
3.27 Scores on a scale
Standard Deviation 0.76
3.56 Scores on a scale
Standard Deviation 0.73
Caregiver Capacity to Appraise Demands: Caregiving Burden Subscale
Week 5 (T3)
3.33 Scores on a scale
Standard Deviation 0.80
3.56 Scores on a scale
Standard Deviation 0.82
Caregiver Capacity to Appraise Demands: Caregiving Burden Subscale
Week 8 (T4)
3.14 Scores on a scale
Standard Deviation 0.77
3.48 Scores on a scale
Standard Deviation 0.90
Caregiver Capacity to Appraise Demands: Caregiving Burden Subscale
Week 11 (T5)
3.21 Scores on a scale
Standard Deviation 0.80
3.59 Scores on a scale
Standard Deviation 0.89
Caregiver Capacity to Appraise Demands: Caregiving Burden Subscale
Week 14 (T6)
3.15 Scores on a scale
Standard Deviation 0.77
3.39 Scores on a scale
Standard Deviation 0.95

PRIMARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

This outcome will be measured using the Revised Caregiving Appraisal Scale (5-point Likert scale) which asks ADRD caregivers to assess five subscales. This subscale focuses on Satisfaction with a minimum value (worse outcome) of 1 and a maximum value (better outcome) of 5.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Caregiver Capacity to Appraise Demands: Caregiving Satisfaction Subscale
Baseline (T1)
3.22 Scores on a scale
Standard Deviation 0.64
3.44 Scores on a scale
Standard Deviation 0.70
Caregiver Capacity to Appraise Demands: Caregiving Satisfaction Subscale
Week 2 (T2)
3.16 Scores on a scale
Standard Deviation 0.52
3.29 Scores on a scale
Standard Deviation 0.96
Caregiver Capacity to Appraise Demands: Caregiving Satisfaction Subscale
Week 5 (T3)
3.16 Scores on a scale
Standard Deviation 0.73
3.02 Scores on a scale
Standard Deviation 0.91
Caregiver Capacity to Appraise Demands: Caregiving Satisfaction Subscale
Week 8 (T4)
3.24 Scores on a scale
Standard Deviation 0.67
2.93 Scores on a scale
Standard Deviation 0.96
Caregiver Capacity to Appraise Demands: Caregiving Satisfaction Subscale
Week 11 (T5)
3.20 Scores on a scale
Standard Deviation 0.84
3.02 Scores on a scale
Standard Deviation 0.88
Caregiver Capacity to Appraise Demands: Caregiving Satisfaction Subscale
Week 14 (T6)
3.18 Scores on a scale
Standard Deviation 0.74
3.18 Scores on a scale
Standard Deviation 1.02

PRIMARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

This outcome will be measured using the Revised Caregiving Appraisal Scale (5-point Likert scale) which asks ADRD caregivers to assess five subscales. This subscale focuses on Mastery with a minimum value (worse outcome) of 1 and a maximum value (better outcome) of 5.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Caregiver Capacity to Appraise Demands: Caregiving Mastery Subscale
Week 5 (T3)
3.81 Scores on a scale
Standard Deviation 0.66
3.26 Scores on a scale
Standard Deviation 0.78
Caregiver Capacity to Appraise Demands: Caregiving Mastery Subscale
Week 8 (T4)
3.86 Scores on a scale
Standard Deviation 0.54
3.49 Scores on a scale
Standard Deviation 0.88
Caregiver Capacity to Appraise Demands: Caregiving Mastery Subscale
Week 11 (T5)
3.79 Scores on a scale
Standard Deviation 0.59
3.43 Scores on a scale
Standard Deviation 0.80
Caregiver Capacity to Appraise Demands: Caregiving Mastery Subscale
Week 14 (T6)
3.99 Scores on a scale
Standard Deviation 0.48
3.52 Scores on a scale
Standard Deviation 0.87
Caregiver Capacity to Appraise Demands: Caregiving Mastery Subscale
Baseline (T1)
3.84 Scores on a scale
Standard Deviation 0.46
3.39 Scores on a scale
Standard Deviation 0.71
Caregiver Capacity to Appraise Demands: Caregiving Mastery Subscale
Week 2 (T2)
3.96 Scores on a scale
Standard Deviation 0.52
3.40 Scores on a scale
Standard Deviation 0.90

PRIMARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

This outcome will be measured using the Revised Caregiving Appraisal Scale (5-point Likert scale) which asks ADRD caregivers to assess five subscales. This subscale focuses on Care Demand with a minimum value (better outcome) of 1 and a maximum value (worse outcome) of 5.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Caregiver Capacity to Appraise Demands: Care Demand Subscale
Baseline (T1)
2.56 Scores on a scale
Standard Deviation 0.66
2.67 Scores on a scale
Standard Deviation 0.91
Caregiver Capacity to Appraise Demands: Care Demand Subscale
Week 2 (T2)
2.60 Scores on a scale
Standard Deviation 0.75
2.93 Scores on a scale
Standard Deviation 1.17
Caregiver Capacity to Appraise Demands: Care Demand Subscale
Week 5 (T3)
2.53 Scores on a scale
Standard Deviation 0.64
3.29 Scores on a scale
Standard Deviation 1.00
Caregiver Capacity to Appraise Demands: Care Demand Subscale
Week 8 (T4)
2.53 Scores on a scale
Standard Deviation 0.74
3.12 Scores on a scale
Standard Deviation 0.91
Caregiver Capacity to Appraise Demands: Care Demand Subscale
Week 11 (T5)
2.47 Scores on a scale
Standard Deviation 0.72
3.29 Scores on a scale
Standard Deviation 1.11
Caregiver Capacity to Appraise Demands: Care Demand Subscale
Week 14 (T6)
2.51 Scores on a scale
Standard Deviation 0.65
3.07 Scores on a scale
Standard Deviation 1.08

PRIMARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

This outcome will be measured using the Revised Caregiving Appraisal Scale (5-point Likert scale) which asks ADRD caregivers to assess five subscales. This subscale focuses on Caregiving Environmental Impact with a minimum value (better outcome) of 1 and a maximum value (worse outcome) of 5.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Caregiver Capacity to Appraise Demands: Caregiving Environmental Impact Subscale
Baseline (T1)
2.44 Scores on a scale
Standard Deviation 1.25
2.60 Scores on a scale
Standard Deviation 0.61
Caregiver Capacity to Appraise Demands: Caregiving Environmental Impact Subscale
Week 2 (T2)
2.60 Scores on a scale
Standard Deviation 1.29
3.00 Scores on a scale
Standard Deviation 1.18
Caregiver Capacity to Appraise Demands: Caregiving Environmental Impact Subscale
Week 5 (T3)
2.49 Scores on a scale
Standard Deviation 1.25
3.21 Scores on a scale
Standard Deviation 1.18
Caregiver Capacity to Appraise Demands: Caregiving Environmental Impact Subscale
Week 8 (T4)
2.47 Scores on a scale
Standard Deviation 1.21
3.21 Scores on a scale
Standard Deviation 0.96
Caregiver Capacity to Appraise Demands: Caregiving Environmental Impact Subscale
Week 11 (T5)
2.44 Scores on a scale
Standard Deviation 1.26
3.31 Scores on a scale
Standard Deviation 0.89
Caregiver Capacity to Appraise Demands: Caregiving Environmental Impact Subscale
Week 14 (T6)
2.20 Scores on a scale
Standard Deviation 1.13
3.31 Scores on a scale
Standard Deviation 1.03

SECONDARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

The Perceived Stress Scale (5-point Likert scale) measures self-reported stress. Each question uses a 5-point Likert scale to gather data, where 0 is the lowest score and 4 is the highest score per item. When totaled across items, this scale has a minimum value (less perceived stress) of 0 and a maximum value (more perceived stress) of 40.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Perceived Stress
Week 11 (T5)
16.73 Scores on a scale
Standard Deviation 6.50
20.57 Scores on a scale
Standard Deviation 6.56
Perceived Stress
Baseline (T1)
16.80 Scores on a scale
Standard Deviation 5.92
21.27 Scores on a scale
Standard Deviation 8.09
Perceived Stress
Week 2 (T2)
16.60 Scores on a scale
Standard Deviation 6.07
19.33 Scores on a scale
Standard Deviation 6.29
Perceived Stress
Week 5 (T3)
17.73 Scores on a scale
Standard Deviation 7.25
22.93 Scores on a scale
Standard Deviation 7.44
Perceived Stress
Week 8 (T4)
15.87 Scores on a scale
Standard Deviation 5.25
21.14 Scores on a scale
Standard Deviation 7.03
Perceived Stress
Week 14 (T6)
16.00 Scores on a scale
Standard Deviation 6.88
19.07 Scores on a scale
Standard Deviation 6.81

SECONDARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

The Modified Caregiver Burden Inventory includes 24 questions that measure five subscales: Time, Physical, Social, Emotional, and Developmental. Each question uses a 5-point Likert scale to gather data, where 0 is the lowest score and 4 is the highest score per item. When totaled across items, this scale has a minimum value (less burden) of 0 and a maximum value (more burden) of 96.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Modified Caregiver Burden Inventory
Baseline (T1)
44.39 Scores on a scale
Standard Deviation 14.82
47.36 Scores on a scale
Standard Deviation 13.58
Modified Caregiver Burden Inventory
Week 2 (T2)
44.81 Scores on a scale
Standard Deviation 16.03
51.04 Scores on a scale
Standard Deviation 17.90
Modified Caregiver Burden Inventory
Week 5 (T3)
46.86 Scores on a scale
Standard Deviation 17.51
54.42 Scores on a scale
Standard Deviation 17.09
Modified Caregiver Burden Inventory
Week 8 (T4)
44.76 Scores on a scale
Standard Deviation 16.19
52.14 Scores on a scale
Standard Deviation 18.65
Modified Caregiver Burden Inventory
Week 11 (T5)
47.84 Scores on a scale
Standard Deviation 17.87
54.98 Scores on a scale
Standard Deviation 18.75
Modified Caregiver Burden Inventory
Week 14 (T6)
46.11 Scores on a scale
Standard Deviation 15.05
51.46 Scores on a scale
Standard Deviation 17.10

SECONDARY outcome

Timeframe: Assessed at six timepoints: baseline (T1), week 2 (T2), week 5 (T3), week 8 (T4), week 11 (T5), and week 14 (T6)

Population: One participant withdrew from the study following T2, which is why the Waitlist Control reports 14 responses following Week 2 (T2).

The Positive Aspects of Caregiving Scale (5-point Likert scale) measures the perceptions of the benefits of caregiving. Nine questions each use a 5-point Likert scale where 1 is the lowest score and 5 the highest score for each item. When totaled across items, this scale has a minimum value (worse outcome) of 9 and a maximum value (better outcome) of 45.

Outcome measures

Outcome measures
Measure
Immediate Intervention
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Waitlist Control
n=15 Participants
We will use a randomized waitlist control design. Participants will be randomly assigned to one of two groups. Group A (Immediate Intervention) will first participate in the intervention (three meetings offered every 2 weeks at Weeks 2, 4, and 6), followed by 8 weeks of follow-up. T1 will be a pretest gathered at enrollment. Group B (Waitlist Control) will wait 8 weeks and then start the intervention at Weeks 8, 10, and 12, with a posttest at Week 14. Data will be gathered at six time points no less than 2 weeks apart over the course of the control, intervention, and follow-up.
Positive Aspects of Caregiving Scale
Baseline (T1)
31.47 Scores on a scale
Standard Deviation 6.67
31.13 Scores on a scale
Standard Deviation 6.99
Positive Aspects of Caregiving Scale
Week 2 (T2)
31.13 Scores on a scale
Standard Deviation 6.14
32.13 Scores on a scale
Standard Deviation 7.20
Positive Aspects of Caregiving Scale
Week 5 (T3)
32.33 Scores on a scale
Standard Deviation 7.19
28.29 Scores on a scale
Standard Deviation 8.66
Positive Aspects of Caregiving Scale
Week 8 (T4)
33.13 Scores on a scale
Standard Deviation 6.78
29.21 Scores on a scale
Standard Deviation 8.99
Positive Aspects of Caregiving Scale
Week 11 (T5)
33.27 Scores on a scale
Standard Deviation 6.64
27.50 Scores on a scale
Standard Deviation 10.19
Positive Aspects of Caregiving Scale
Week 14 (T6)
33.07 Scores on a scale
Standard Deviation 6.63
28.43 Scores on a scale
Standard Deviation 8.86

Adverse Events

Immediate Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Waitlist Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacqueline Eaton

University of Utah

Phone: 801-587-9638

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place