Improving Care Through Improv: Promoting Mastery in the Moment
Primary Purpose
Caregiver Burden
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Training program pilot
Sponsored by
About this trial
This is an interventional other trial for Caregiver Burden
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Informal Caregivers of Persons Living with Dementia
Arm Description
Participants will receive the training program, "Improving Care through Improv." This involves four weekly 2-hour in-person training sessions.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Perceived Stress Scale
14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.
Center for Epidemiological Studies-Depression Scale
20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.
State-Trait Anxiety Inventory
20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.
Zarit Burden Inventory
22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.
Revised Memory and Behavioral Problems Checklist
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.
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
Full Information
NCT ID
NCT05996718
First Posted
August 10, 2023
Last Updated
August 18, 2023
Sponsor
Georgia State University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05996718
Brief Title
Improving Care Through Improv: Promoting Mastery in the Moment
Official Title
Improving Care Through Improv: Promoting Mastery in the Moment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Informal Caregivers of Persons Living with Dementia
Arm Type
Experimental
Arm Description
Participants will receive the training program, "Improving Care through Improv." This involves four weekly 2-hour in-person training sessions.
Intervention Type
Behavioral
Intervention Name(s)
Training program pilot
Intervention Description
This intervention for informal caregivers consists of training that will introduce participants to improvisational (improv) theatre and teach its core communication skills.
Primary Outcome Measure Information:
Title
Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale
Description
4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.
Time Frame
at baseline, upon training completion (Week 4), and three months post baseline.
Secondary Outcome Measure Information:
Title
Perceived Stress Scale
Description
14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.
Time Frame
at baseline, upon training completion (Week 4), and three months post baseline.
Title
Center for Epidemiological Studies-Depression Scale
Description
20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.
Time Frame
at baseline, upon training completion (Week 4), and three months post baseline.
Title
State-Trait Anxiety Inventory
Description
20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.
Time Frame
at baseline, upon training completion (Week 4), and three months post baseline.
Title
Zarit Burden Inventory
Description
22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.
Time Frame
at baseline, upon training completion (Week 4), and three months post baseline.
Title
Revised Memory and Behavioral Problems Checklist
Description
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.
Time Frame
at baseline, upon training completion (Week 4), and three months post baseline.
Title
Quality of Life-Alzheimer's Disease Scale
Description
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
Time Frame
at baseline, upon training completion (Week 4), and three months post baseline.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Candace L Kemp, PhD
Phone
404-413-5216
Email
ckemp@gsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Crystal W Williams, DrPH
Email
cwilliams259@gsu.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Improving Care Through Improv: Promoting Mastery in the Moment
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