Caregiver BurdenNCT05996718
Improving Care Through Improv: Promoting Mastery in the Moment
A study testing Training program pilot in people with Caregiver Burden, run by Georgia State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Training program pilot
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 20 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Caregiver Burden
- Being tested
- Training program pilot
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training program pilotBehavioural
This intervention for informal caregivers consists of training that will introduce participants to improvisational (improv) theatre and teach its core communication skills.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Training program pilot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, upon training completion (Week 4), and three months post baseline.
Secondary outcomes (7)
Perceived Stress Scale
14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.
Measured: at baseline, upon training completion (Week 4), and three months post baseline.
Center for Epidemiological Studies-Depression Scale
20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.
Measured: at baseline, upon training completion (Week 4), and three months post baseline.
State-Trait Anxiety Inventory
20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.
Measured: at baseline, upon training completion (Week 4), and three months post baseline.
Zarit Burden Inventory
22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.
Measured: at baseline, upon training completion (Week 4), and three months post baseline.
Revised Memory and Behavioral Problems Checklist - FREQUENCY
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.
Measured: at baseline, upon training completion (Week 4), and three months post baseline.
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
Measured: at baseline, upon training completion (Week 4), and three months post baseline.
Revised Memory and Behavioral Problems Checklist - REACTION
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.
Measured: at baseline, upon training completion (Week 4), and three months post baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start25 Oct 2023
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Candace Kemp, Georgia State University
- Investigators
- Candace L Kemp, PhD, Principal investigator, Georgia State Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05996718
- Sponsor's protocol ID
- P30AG064200
- Other IDs
- DBSR-11114, P30AG064200
- Status last verified
- Jun 2025
- First submitted
- 10 Aug 2023
- Last updated
- 11 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Kemp CL, Anglin E, Morgan JC, Johnson Ii TM. Improving Care through Improv: pilot test results of an innovative training program for care partners of people living with dementia. Gerontologist. 2026 Mar 9;66(4):gnaf240. doi: 10.1093/geront/gnaf240.
PubMed 41181875
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Care Through Improv: Promoting Mastery in the Moment
- ClinicalTrials.gov ID
- NCT05996718
- Acronym / sponsor ID
- P30AG064200
- Conditions
- Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Posted 11 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Informal Caregivers of Persons Living with Dementia | Experimental | Behavioral: Training program pilotParticipants will receive the training program, "Improving Care through Improv." This involves four weekly 2-hour in-person training sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training program pilotThis intervention for informal caregivers consists of training that will introduce participants to improvisational (improv) theatre and teach its core communication skills. | Behavioural | Informal Caregivers of Persons Living with Dementia |
Primary outcome
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.
7 secondary outcomes
Perceived Stress Scale
Time frame: 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.
State-Trait Anxiety Inventory
Time frame: 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.
Revised Memory and Behavioral Problems Checklist - FREQUENCY
Time frame: 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.
Revised Memory and Behavioral Problems Checklist - REACTION
Time frame: at baseline, upon training completion (Week 4), and three months post baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41181875Kemp CL, Anglin E, Morgan JC, Johnson Ii TM. Improving Care through Improv: pilot test results of an innovative training program for care partners of people living with dementia. Gerontologist. 2026 Mar 9;66(4):gnaf240. doi: 10.1093/geront/gnaf240.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candace L Kemp, PhD principal investigator
Georgia State Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training program pilot in people with Caregiver Burden, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale (time frame: at baseline, upon training completion (Week 4), and three months post baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05996718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.