NCT05996718

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 25, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 11, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

7 months

First QC Date

August 10, 2023

Results QC Date

May 18, 2025

Last Update Submit

June 10, 2025

Conditions

Caregiver Burden

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Perceived Stress Scale

    at baseline, upon training completion (Week 4), and three months post baseline.

  • Center for Epidemiological Studies-Depression Scale

    at baseline, upon training completion (Week 4), and three months post baseline.

  • State-Trait Anxiety Inventory

    at baseline, upon training completion (Week 4), and three months post baseline.

  • Zarit Burden Inventory

    at baseline, upon training completion (Week 4), and three months post baseline.

  • Revised Memory and Behavioral Problems Checklist - FREQUENCY

    at baseline, upon training completion (Week 4), and three months post baseline.

  • +2 more secondary outcomes

Study Arms (1)

Informal Caregivers of Persons Living with Dementia

EXPERIMENTAL

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

Behavioral: Training program pilot

Interventions

Training program pilotBEHAVIORAL

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

Informal Caregivers of Persons Living with Dementia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30302, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Results Point of Contact

Title
Candace L. Kemp
Organization
Georgia State University
ckemp@gsu.edu
404-413-5216

Study Officials

  • Candace L Kemp, PhD

    Georgia State Univeristy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

October 25, 2023

Primary Completion

May 20, 2024

Study Completion

May 20, 2024

Last Updated

June 11, 2025

Results First Posted

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Data from this study will be made available to qualified researchers through a data sharing agreement that is consistent with NIH data sharing policies, as well as policies and practices established by the Roybal Center for Dementia Caregiving Mastery at Emory University. The data to be collected include common data elements, including the Caregiver Mastery Scale developed by Pearlin and colleagues, as well as demographic characteristics. Although these data will be de-identified prior to release for sharing, there remains a possibility of deductive disclosure of participants with unusual characteristics. Therefore, this data sharing agreement will require: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.

Time Frame
Study data will be made available no later than the on-line publication date of the main findings from the final dataset.
Access Criteria
Researchers must qualify and enter into a data sharing agreement. The agreement requires: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.

Locations

US(1)