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| ID | Type | Description | Link |
|---|---|---|---|
| DBSR-11114 | Other Identifier | NIA CROMS | |
| P30AG064200 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training program pilot | Behavioral | This intervention for informal caregivers consists of training that will introduce participants to improvisational (improv) theatre and teach its core communication skills. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Center for Epidemiological Studies-Depression Scale |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Candace L Kemp, PhD | Georgia State Univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30302 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41181875 | Derived | 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. |
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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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Study data will be made available no later than the on-line publication date of the main findings from the final dataset.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caregivers | Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Caregivers | Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey. | Posted | Mean | Standard Deviation | Score on a scale | at baseline, upon training completion (Week 4), and three months post baseline. |
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Data were collected for 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caregivers | Caregiver of a person living with dementia participating in the Improving Care through Improv intervention. During the intervention, participants attended four 2-hour weekly in-person group classes designed to enhance caregiver mastery and improve well-being among family members and friends providing care to someone living with dementia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Candace L. Kemp | Georgia State University | 404-413-5216 | ckemp@gsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 27, 2024 | May 18, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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 | 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 | 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. |
| 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. | 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 | 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. | at baseline, upon training completion (Week 4), and three months post baseline. |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | This study was conducted in Atlanta, Georgia, USA. | Number | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Secondary | Perceived Stress Scale | 14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress. | Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey. | Posted | Mean | Standard Deviation | Score on a scale | at baseline, upon training completion (Week 4), and three months post baseline. |
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| Secondary | Center for Epidemiological Studies-Depression Scale | 20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression. | Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey. | Posted | Mean | Standard Deviation | Score on a scale | at baseline, upon training completion (Week 4), and three months post baseline. |
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| Secondary | State-Trait Anxiety Inventory | 20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety. | Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey. | Posted | Mean | Standard Deviation | Score on a scale | at baseline, upon training completion (Week 4), and three months post baseline. |
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| 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. | Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey. | Posted | Mean | Standard Deviation | Score on a scale | at baseline, upon training completion (Week 4), and three months post baseline. |
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| Secondary | 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. | Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey. | Posted | Mean | Standard Deviation | Score on a scale | at baseline, upon training completion (Week 4), and three months post baseline. |
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| 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 | Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey. | Posted | Mean | Standard Deviation | Score on a scale | at baseline, upon training completion (Week 4), and three months post baseline. |
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| Secondary | 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. | Forty-three caregivers began the study; 42 completed the survey at Month 1; 40 completed the month 3 survey. | Posted | Mean | Standard Deviation | Score on a scale | at baseline, upon training completion (Week 4), and three months post baseline. |
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