Improving Care Through Improv: Promoting Mastery in the Moment

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05996718

Enrollment

Registered

2023-08-18

Start date

2023-10-25

Completion date

2024-05-20

Last updated

2025-06-11

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

Conditions

Caregiver Burden

Brief summary

The goals of this clinical trial are to: 1) refine the training program, Improving Care though Improv; and 2) test the program for its influence self-perceived caregiving mastery (i.e., how persons assess their ability to provide care) among informal caregivers of persons living with moderate dementia. Forty-three informal caregivers will be involved in testing the training program. These individuals will be assigned to groups of between 8 to12 caregivers and take part in weekly 2-hour sessions held over a 4-week period. These caregivers will be taught improvisational (improv) theater skills, which involves being in the moment, self-awareness, and responsiveness to others. This group also will be asked to answer surveys questions about themselves and the person receiving care at three timepoints and invited to provide feedback on their training experiences.

Interventions

BEHAVIORALTraining program pilot

This intervention for informal caregivers consists of training that will introduce participants to improvisational (improv) theatre and teach its core communication skills.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Actively engaged in the care of community-dwelling persons living with moderate dementia (4 or 5 on a 7-point dementia-staging scale) who is not likely to be institutionalized within the next 6 months * Able to attend at least 3 of the 4 in-person sessions * Ability to communicate in English

Exclusion criteria

Potential participants were excluded if they did not meet the above criteria or anticipated moving their person to a skilled nursing facility within the next 6 months.

Design outcomes

Primary

Measure	Time frame	Description
Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale	at baseline, upon training completion (Week 4), and three months post baseline.	4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.

Secondary

Measure	Time frame	Description
Center for Epidemiological Studies-Depression Scale	at baseline, upon training completion (Week 4), and three months post baseline.	20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.
State-Trait Anxiety Inventory	at baseline, upon training completion (Week 4), and three months post baseline.	20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.
Zarit Burden Inventory	at baseline, upon training completion (Week 4), and three months post baseline.	22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.
Perceived Stress Scale	at baseline, upon training completion (Week 4), and three months post baseline.	14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.
Quality of Life-Alzheimer's Disease Scale	at baseline, upon training completion (Week 4), and three months post baseline.	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
Revised Memory and Behavioral Problems Checklist - REACTION	at baseline, upon training completion (Week 4), and three months post baseline.	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.
Revised Memory and Behavioral Problems Checklist - FREQUENCY	at baseline, upon training completion (Week 4), and three months post baseline.	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	43
Total	43

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	3

Baseline characteristics

Characteristic	Caregivers
Age, Continuous	58.87 Years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	1 Participants
Race (NIH/OMB) Black or African American	10 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	31 Participants
Region of Enrollment United States	43 Participants
Sex: Female, Male Female	38 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 43
other Total, other adverse events	0 / 43
serious Total, serious adverse events	0 / 43

Outcome results

Primary

Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale

4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.