Back to resultsPowerful Tools for Caregivers of Dementia Patients (PTC-dementia)
Primary Purpose
Caregivers, Dementia, Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Powerful Tools for Caregivers
Control with delayed intervention
Sponsored by
About this trial
This is an interventional treatment trial for Caregivers focused on measuring Caregivers, Behavioral symptoms, Dementia, Alzheimer disease, Physical activity, Depressive symptoms, Powerful Tools for Caregivers, Chronic Disease Self-Management Program
Eligibility Criteria
Inclusion Criteria:
- Caregiver lives with or provides care for the care recipient for an average of at least 4 hours per day.
- Care for an individual with a physician diagnosis of dementia (mild to moderate stage of dementia).
- Care for a care recipient who experiences behavioral symptoms that bother or upset the caregiver moderately, very much, or extremely. The occurrence of problematic behaviors and caregivers' reactions will be assessed with 6-items adapted from the Revised Memory and Behavior Problems Checklist (Teri et al 1992).
Exclusion Criteria:
- Care for a care recipient who is bed-bound or has advanced dementia: Functional Assessment Staging (FAST)(Sclan & Reisberg 1992) stage 7.
- Caregiver's cognitive, hearing, visual, or other physical impairments lead to difficulty with informed consent process, assessment, or participation in the intervention.
- Caregiver who is involved in another trial that addresses caregiver burden or behavioral expressions.
Sites / Locations
- Florida State University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Powerful Tools for Caregivers
Control group, delayed intervention
Arm Description
A 6-week psycho-educational program
Control group with delayed intervention
Outcomes
Primary Outcome Measures
Caregiver Burden
Zarit Caregiver Burden Scale scores
Frequency and reaction to care recipient behavioral and psychological symptoms of dementia
Revised Memory and Behavior Problems Checklist scores
Frequency of care recipient agitated behaviors
Cohen-Mansfield Agitation Inventory scores
Secondary Outcome Measures
Activity parameters as assessed by FitBit
Depressive symptoms
Center for Epidemiologic Studies Depression Scale scores
Caregiving Self-Efficacy
Caregiving Self-Efficacy Scale scores
Self-rated health
Single item "In general, would you say your health is...." with response options from 1= poor to 5=excellent.
Life satisfaction
Single item "I am satisfied with my life" with response options from 0=Strongly disagree to 4=Strongly agree
Perceived change
Perceived Change Index score
Neuropsychiatric symptoms in care recipients
Neuropsychiatric Inventory score
Full Information
NCT ID
NCT02697721
First Posted
February 17, 2016
Last Updated
January 26, 2021
Sponsor
Florida State University
Collaborators
Florida Department of Health
1. Study Identification
Unique Protocol Identification Number
NCT02697721
Brief Title
Powerful Tools for Caregivers of Dementia Patients
Acronym
PTC-dementia
Official Title
Optimization of "Powerful Tools for Caregivers" of Dementia Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
Florida Department of Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to examine if a psycho-educational intervention for caregivers of patients with dementia will decrease caregiver burden, increase caregiver physical activity, and decrease the reporting of behavioral and psychological symptoms of the person with dementia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers, Dementia, Alzheimer Disease
Keywords
Caregivers, Behavioral symptoms, Dementia, Alzheimer disease, Physical activity, Depressive symptoms, Powerful Tools for Caregivers, Chronic Disease Self-Management Program
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Powerful Tools for Caregivers
Arm Type
Experimental
Arm Description
A 6-week psycho-educational program
Arm Title
Control group, delayed intervention
Arm Type
Other
Arm Description
Control group with delayed intervention
Intervention Type
Behavioral
Intervention Name(s)
Powerful Tools for Caregivers
Intervention Description
Powerful Tools for Caregivers is a 6-week psychoeducational program. Each week the caregivers will attend a 90-minute workshop in a group setting. These sessions will be co-led by two trained and certified leaders who follow the scripted program. In addition to providing education about caregiving and the importance of self-care, the classes will help caregivers develop self-care tools to manage personal stress and improve communication skills.
Intervention Type
Other
Intervention Name(s)
Control with delayed intervention
Intervention Description
Control with delayed intervention
Primary Outcome Measure Information:
Title
Caregiver Burden
Description
Zarit Caregiver Burden Scale scores
Time Frame
6 weeks
Title
Frequency and reaction to care recipient behavioral and psychological symptoms of dementia
Description
Revised Memory and Behavior Problems Checklist scores
Time Frame
6 weeks
Title
Frequency of care recipient agitated behaviors
Description
Cohen-Mansfield Agitation Inventory scores
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Activity parameters as assessed by FitBit
Time Frame
6 weeks
Title
Depressive symptoms
Description
Center for Epidemiologic Studies Depression Scale scores
Time Frame
6 weeks
Title
Caregiving Self-Efficacy
Description
Caregiving Self-Efficacy Scale scores
Time Frame
6 weeks
Title
Self-rated health
Description
Single item "In general, would you say your health is...." with response options from 1= poor to 5=excellent.
Time Frame
6 weeks
Title
Life satisfaction
Description
Single item "I am satisfied with my life" with response options from 0=Strongly disagree to 4=Strongly agree
Time Frame
6 weeks
Title
Perceived change
Description
Perceived Change Index score
Time Frame
6 weeks
Title
Neuropsychiatric symptoms in care recipients
Description
Neuropsychiatric Inventory score
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Caregiver lives with or provides care for the care recipient for an average of at least 4 hours per day.
Care for an individual with a physician diagnosis of dementia (mild to moderate stage of dementia).
Care for a care recipient who experiences behavioral symptoms that bother or upset the caregiver moderately, very much, or extremely. The occurrence of problematic behaviors and caregivers' reactions will be assessed with 6-items adapted from the Revised Memory and Behavior Problems Checklist (Teri et al 1992).
Exclusion Criteria:
Care for a care recipient who is bed-bound or has advanced dementia: Functional Assessment Staging (FAST)(Sclan & Reisberg 1992) stage 7.
Caregiver's cognitive, hearing, visual, or other physical impairments lead to difficulty with informed consent process, assessment, or participation in the intervention.
Caregiver who is involved in another trial that addresses caregiver burden or behavioral expressions.
Facility Information:
Facility Name
Florida State University College of Medicine
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31866419
Citation
Terracciano A, Artese A, Yeh J, Edgerton L, Granville L, Aschwanden D, Luchetti M, Glueckauf RL, Stephan Y, Sutin AR, Katz P. Effectiveness of Powerful Tools for Caregivers on Caregiver Burden and on Care Recipient Behavioral and Psychological Symptoms of Dementia: A Randomized Controlled Trial. J Am Med Dir Assoc. 2020 Aug;21(8):1121-1127.e1. doi: 10.1016/j.jamda.2019.11.011. Epub 2019 Dec 19.
Results Reference
result
Learn more about this trial
Powerful Tools for Caregivers of Dementia Patients
We'll reach out to this number within 24 hrs