PTC-dementia: Powerful Tools for Caregivers of Dementia Patients

Sponsor
Florida State University (Other)
Overall Status
Completed
CT.gov ID
NCT02697721
Collaborator
Florida Department of Health (Other)
60
1
2
36
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Powerful Tools for Caregivers
  • Other: Control with delayed intervention
N/A

Study Design

Study Type:
Interventional
Anticipated 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 :
Feb 1, 2016
Actual Primary Completion Date :
May 30, 2018
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Caregiver Burden [6 weeks]

    Zarit Caregiver Burden Scale scores

  2. Frequency and reaction to care recipient behavioral and psychological symptoms of dementia [6 weeks]

    Revised Memory and Behavior Problems Checklist scores

  3. Frequency of care recipient agitated behaviors [6 weeks]

    Cohen-Mansfield Agitation Inventory scores

Secondary Outcome Measures

  1. Activity parameters as assessed by FitBit [6 weeks]

  2. Depressive symptoms [6 weeks]

    Center for Epidemiologic Studies Depression Scale scores

  3. Caregiving Self-Efficacy [6 weeks]

    Caregiving Self-Efficacy Scale scores

  4. Self-rated health [6 weeks]

    Single item "In general, would you say your health is...." with response options from 1= poor to 5=excellent.

  5. Life satisfaction [6 weeks]

    Single item "I am satisfied with my life" with response options from 0=Strongly disagree to 4=Strongly agree

  6. Perceived change [6 weeks]

    Perceived Change Index score

  7. Neuropsychiatric symptoms in care recipients [6 weeks]

    Neuropsychiatric Inventory score

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Florida State University College of Medicine Tallahassee Florida United States 32306

Sponsors and Collaborators

  • Florida State University
  • Florida Department of Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Antonio Terracciano, Professor, Florida State University
ClinicalTrials.gov Identifier:
NCT02697721
Other Study ID Numbers:
  • 6AZ09
First Posted:
Mar 3, 2016
Last Update Posted:
Jan 29, 2021
Last Verified:
Jan 1, 2021

Study Results

No Results Posted as of Jan 29, 2021