Improving Care Through Improv: Promoting Mastery in the Moment

June 10, 2025 updated by: Candace Kemp, Georgia State University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Candace L Kemp, PhD
  • Phone Number: 404-413-5216
  • Email: ckemp@gsu.edu

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30302
        • Georgia State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale
Time Frame: 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.
at baseline, upon training completion (Week 4), and three months post baseline.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceived Stress Scale
Time Frame: 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.
at baseline, upon training completion (Week 4), and three months post baseline.
Center for Epidemiological Studies-Depression Scale
Time Frame: 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.
at baseline, upon training completion (Week 4), and three months post baseline.
State-Trait Anxiety Inventory
Time Frame: 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.
at baseline, upon training completion (Week 4), and three months post baseline.
Zarit Burden Inventory
Time Frame: 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.
at baseline, upon training completion (Week 4), and three months post baseline.
Quality of Life-Alzheimer's Disease Scale
Time Frame: 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
at baseline, upon training completion (Week 4), and three months post baseline.
Revised Memory and Behavioral Problems Checklist - FREQUENCY
Time Frame: 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.
at baseline, upon training completion (Week 4), and three months post baseline.
Revised Memory and Behavioral Problems Checklist - REACTION
Time Frame: 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.
at baseline, upon training completion (Week 4), and three months post baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgia State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Candace L Kemp, PhD, Georgia State Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 10, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P30AG064200 (U.S. NIH Grant/Contract)
  • DBSR-11114 (Other Identifier: NIA CROMS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Study data will be made available no later than the on-line publication date of the main findings from the final dataset.

IPD Sharing 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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