Improving Care Through Improv: Promoting Mastery in the Moment

Sponsor
Georgia State University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05996718
Collaborator
National Institute on Aging (NIA) (NIH)
40
1
8

Study Details

Study Description

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 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Training program pilot
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Improving Care Through Improv: Promoting Mastery in the Moment
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Informal Caregivers of Persons Living with Dementia

Participants will receive the training program, "Improving Care through Improv." This involves four weekly 2-hour in-person training sessions.

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.

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Revised Memory and Behavioral Problems Checklist [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.

  6. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Georgia State University
  • National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Candace Kemp, Professor, Georgia State University
ClinicalTrials.gov Identifier:
NCT05996718
Other Study ID Numbers:
  • P30AG064200
  • DBSR-11114
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023