Trial Outcomes & Findings for Improving Care Through Improv: Promoting Mastery in the Moment (NCT NCT05996718)
NCT ID: NCT05996718
Last Updated: 2025-06-11
Results Overview
4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.
COMPLETED
NA
43 participants
at baseline, upon training completion (Week 4), and three months post baseline.
2025-06-11
Participant Flow
Participant milestones
| Measure |
Caregivers
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
|
|---|---|
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Overall Study
STARTED
|
43
|
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Overall Study
Completed Month 1 Assessment
|
42
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Caregivers
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
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|---|---|
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Overall Study
Lost to Follow-up
|
3
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Baseline Characteristics
Improving Care Through Improv: Promoting Mastery in the Moment
Baseline characteristics by cohort
| Measure |
Caregivers
n=43 Participants
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
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|---|---|
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Age, Continuous
|
58.87 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at baseline, upon training completion (Week 4), and three months post baseline.Population: Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.
4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.
Outcome measures
| Measure |
Caregivers
n=43 Participants
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
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|---|---|
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Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale
Baseline
|
11.10 Score on a scale
Standard Deviation 2.31
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Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale
Month 1
|
11.63 Score on a scale
Standard Deviation 2.07
|
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Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale
Month 3
|
11.93 Score on a scale
Standard Deviation 2.06
|
SECONDARY outcome
Timeframe: at baseline, upon training completion (Week 4), and three months post baseline.Population: Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.
14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.
Outcome measures
| Measure |
Caregivers
n=43 Participants
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
|
|---|---|
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Perceived Stress Scale
Month 1
|
26.65 Score on a scale
Standard Deviation 9.45
|
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Perceived Stress Scale
Month 3
|
23.10 Score on a scale
Standard Deviation 8.16
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Perceived Stress Scale
Baseline
|
26.25 Score on a scale
Standard Deviation 8.43
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SECONDARY outcome
Timeframe: at baseline, upon training completion (Week 4), and three months post baseline.Population: Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.
20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.
Outcome measures
| Measure |
Caregivers
n=43 Participants
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
|
|---|---|
|
Center for Epidemiological Studies-Depression Scale
Baseline
|
14.83 Score on a scale
Standard Deviation 9.30
|
|
Center for Epidemiological Studies-Depression Scale
Month 1
|
14.78 Score on a scale
Standard Deviation 9.45
|
|
Center for Epidemiological Studies-Depression Scale
Month 3
|
12.98 Score on a scale
Standard Deviation 9.40
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SECONDARY outcome
Timeframe: at baseline, upon training completion (Week 4), and three months post baseline.Population: Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.
20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.
Outcome measures
| Measure |
Caregivers
n=43 Participants
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
|
|---|---|
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State-Trait Anxiety Inventory
Baseline
|
36.15 Score on a scale
Standard Deviation 10.27
|
|
State-Trait Anxiety Inventory
Month 1
|
35.38 Score on a scale
Standard Deviation 11.09
|
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State-Trait Anxiety Inventory
Month 3
|
34.85 Score on a scale
Standard Deviation 11.62
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SECONDARY outcome
Timeframe: at baseline, upon training completion (Week 4), and three months post baseline.Population: Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.
22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.
Outcome measures
| Measure |
Caregivers
n=43 Participants
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
|
|---|---|
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Zarit Burden Inventory
Baseline
|
61.95 Score on a scale
Standard Deviation 16.32
|
|
Zarit Burden Inventory
Month 1
|
61.63 Score on a scale
Standard Deviation 15.19
|
|
Zarit Burden Inventory
Month 3
|
59.68 Score on a scale
Standard Deviation 16.43
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SECONDARY outcome
Timeframe: at baseline, upon training completion (Week 4), and three months post baseline.Population: Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.
24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.
Outcome measures
| Measure |
Caregivers
n=43 Participants
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
|
|---|---|
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Revised Memory and Behavioral Problems Checklist - FREQUENCY
Baseline
|
37.20 Score on a scale
Standard Deviation 14.21
|
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Revised Memory and Behavioral Problems Checklist - FREQUENCY
Month 1
|
36.55 Score on a scale
Standard Deviation 11.99
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Revised Memory and Behavioral Problems Checklist - FREQUENCY
Month 3
|
38.05 Score on a scale
Standard Deviation 13.78
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SECONDARY outcome
Timeframe: at baseline, upon training completion (Week 4), and three months post baseline.Population: Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.
13 items with a 4-point Likert scale. Scores range from 13 to with 52 with higher scores indicating greater quality of life among persons living with dementia
Outcome measures
| Measure |
Caregivers
n=43 Participants
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
|
|---|---|
|
Quality of Life-Alzheimer's Disease Scale
Baseline
|
27.85 Score on a scale
Standard Deviation 5.15
|
|
Quality of Life-Alzheimer's Disease Scale
Month 1
|
27.88 Score on a scale
Standard Deviation 4.20
|
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Quality of Life-Alzheimer's Disease Scale
Month 3
|
27.63 Score on a scale
Standard Deviation 5.16
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SECONDARY outcome
Timeframe: at baseline, upon training completion (Week 4), and three months post baseline.Population: Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey.
24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.
Outcome measures
| Measure |
Caregivers
n=43 Participants
Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia.
|
|---|---|
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Revised Memory and Behavioral Problems Checklist - REACTION
Baseline
|
20.13 Score on a scale
Standard Deviation 13.27
|
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Revised Memory and Behavioral Problems Checklist - REACTION
Month 1
|
19.70 Score on a scale
Standard Deviation 12.21
|
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Revised Memory and Behavioral Problems Checklist - REACTION
Month 3
|
16.35 Score on a scale
Standard Deviation 12.05
|
Adverse Events
Caregivers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place