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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02697721
Other study ID # 6AZ09
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date February 2019

Study information

Verified date January 2021
Source Florida State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2019
Est. primary completion date May 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Powerful Tools for Caregivers
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.
Other:
Control with delayed intervention
Control with delayed intervention

Locations

Country Name City State
United States Florida State University College of Medicine Tallahassee Florida

Sponsors (2)

Lead Sponsor Collaborator
Florida State University Florida Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Caregiver Burden Zarit Caregiver Burden Scale scores 6 weeks
Primary Frequency and reaction to care recipient behavioral and psychological symptoms of dementia Revised Memory and Behavior Problems Checklist scores 6 weeks
Primary Frequency of care recipient agitated behaviors Cohen-Mansfield Agitation Inventory scores 6 weeks
Secondary Activity parameters as assessed by FitBit 6 weeks
Secondary Depressive symptoms Center for Epidemiologic Studies Depression Scale scores 6 weeks
Secondary Caregiving Self-Efficacy Caregiving Self-Efficacy Scale scores 6 weeks
Secondary Self-rated health Single item "In general, would you say your health is...." with response options from 1= poor to 5=excellent. 6 weeks
Secondary Life satisfaction Single item "I am satisfied with my life" with response options from 0=Strongly disagree to 4=Strongly agree 6 weeks
Secondary Perceived change Perceived Change Index score 6 weeks
Secondary Neuropsychiatric symptoms in care recipients Neuropsychiatric Inventory score 6 weeks
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