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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
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Caregiver Burden

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    August 10, 2023
    Last Updated
    August 18, 2023
    Sponsor
    Georgia State University
    Collaborators
    National Institute on Aging (NIA)
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    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.

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    Improving Care Through Improv: Promoting Mastery in the Moment

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