Powerful Tools for Caregivers of Dementia Patients (PTC-dementia)

January 26, 2021 updated by: Antonio Terracciano, Florida State University

Optimization of "Powerful Tools for Caregivers" of Dementia Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tallahassee, Florida, United States, 32306
        • Florida State University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Powerful Tools for Caregivers
A 6-week psycho-educational program
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 group, delayed intervention
Control group with delayed intervention
Other: Control with delayed intervention
Control with delayed intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Burden
Time Frame: 6 weeks
Zarit Caregiver Burden Scale scores
6 weeks
Frequency and reaction to care recipient behavioral and psychological symptoms of dementia
Time Frame: 6 weeks
Revised Memory and Behavior Problems Checklist scores
6 weeks
Frequency of care recipient agitated behaviors
Time Frame: 6 weeks
Cohen-Mansfield Agitation Inventory scores
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity parameters as assessed by FitBit
Time Frame: 6 weeks
6 weeks
Depressive symptoms
Time Frame: 6 weeks
Center for Epidemiologic Studies Depression Scale scores
6 weeks
Caregiving Self-Efficacy
Time Frame: 6 weeks
Caregiving Self-Efficacy Scale scores
6 weeks
Self-rated health
Time Frame: 6 weeks
Single item "In general, would you say your health is...." with response options from 1= poor to 5=excellent.
6 weeks
Life satisfaction
Time Frame: 6 weeks
Single item "I am satisfied with my life" with response options from 0=Strongly disagree to 4=Strongly agree
6 weeks
Perceived change
Time Frame: 6 weeks
Perceived Change Index score
6 weeks
Neuropsychiatric symptoms in care recipients
Time Frame: 6 weeks
Neuropsychiatric Inventory score
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Collaborators

Florida Department of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

May 30, 2018

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

February 17, 2016

First Submitted That Met QC Criteria

February 29, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6AZ09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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