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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02697721
Recruitment Status : Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : August 21, 2018
Florida Department of Health
Information provided by (Responsible Party):
Florida State University

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.

Condition or disease Intervention/treatment Phase
Caregivers Dementia Alzheimer Disease Behavioral: Powerful Tools for Caregivers Other: Control with delayed intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimization of "Powerful Tools for Caregivers" of Dementia Patients
Actual Study Start Date : February 2016
Actual Primary Completion Date : May 30, 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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.

Control group, delayed intervention
Control group with delayed intervention
Other: Control with delayed intervention
Control with delayed intervention

Primary Outcome Measures :
  1. Caregiver Burden [ Time Frame: 6 weeks ]
    Zarit Caregiver Burden Scale scores

  2. Frequency and reaction to care recipient behavioral and psychological symptoms of dementia [ Time Frame: 6 weeks ]
    Revised Memory and Behavior Problems Checklist scores

  3. Frequency of care recipient agitated behaviors [ Time Frame: 6 weeks ]
    Cohen-Mansfield Agitation Inventory scores

Secondary Outcome Measures :
  1. Activity parameters as assessed by FitBit [ Time Frame: 6 weeks ]
  2. Depressive symptoms [ Time Frame: 6 weeks ]
    Center for Epidemiologic Studies Depression Scale scores

  3. Caregiving Self-Efficacy [ Time Frame: 6 weeks ]
    Caregiving Self-Efficacy Scale scores

  4. 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.

  5. 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. Perceived change [ Time Frame: 6 weeks ]
    Perceived Change Index score

  7. Neuropsychiatric symptoms in care recipients [ Time Frame: 6 weeks ]
    Neuropsychiatric Inventory score

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02697721

United States, Florida
Florida State University College of Medicine
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
Florida Department of Health

Responsible Party: Florida State University Identifier: NCT02697721     History of Changes
Other Study ID Numbers: 6AZ09
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: April 2018

Keywords provided by Florida State University:
Behavioral symptoms
Alzheimer disease
Physical activity
Depressive symptoms
Powerful Tools for Caregivers
Chronic Disease Self-Management Program

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders