Improving Care Through Improv: Promoting Mastery in the Moment

Caregiver Burden Clinical Trial

Official title:

Improving Care Through Improv: Promoting Mastery in the Moment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05996718
• Other study ID #: P30AG064200
• Secondary ID: DBSR-11114
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Georgia State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden

Intervention

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

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Georgia State University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

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