NCT02697721

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

2.3 years

First QC Date

February 17, 2016

Last Update Submit

January 26, 2021

Conditions

CaregiversDementiaAlzheimer Disease

Keywords

CaregiversBehavioral symptomsDementiaAlzheimer diseasePhysical activityDepressive symptomsPowerful Tools for CaregiversChronic Disease Self-Management Program

Outcome Measures

Primary Outcomes (3)

  • Caregiver Burden

    Zarit Caregiver Burden Scale scores

    6 weeks

  • Frequency and reaction to care recipient behavioral and psychological symptoms of dementia

    Revised Memory and Behavior Problems Checklist scores

    6 weeks

  • Frequency of care recipient agitated behaviors

    Cohen-Mansfield Agitation Inventory scores

    6 weeks

Secondary Outcomes (7)

  • Activity parameters as assessed by FitBit

    6 weeks

  • Depressive symptoms

    6 weeks

  • Caregiving Self-Efficacy

    6 weeks

  • Self-rated health

    6 weeks

  • Life satisfaction

    6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Powerful Tools for Caregivers

EXPERIMENTAL

A 6-week psycho-educational program

Behavioral: Powerful Tools for Caregivers

Control group, delayed intervention

OTHER

Control group with delayed intervention

Other: Control with delayed intervention

Interventions

Powerful Tools for CaregiversBEHAVIORAL

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.

Powerful Tools for Caregivers
Control with delayed interventionOTHER

Control with delayed intervention

Control group, delayed intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University College of Medicine

Tallahassee, Florida, 32306, United States

Location

Related 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 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.

    PMID: 31866419RESULT

MeSH Terms

Conditions

DementiaAlzheimer DiseaseBehavioral SymptomsMotor ActivityDepression

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesBehavior

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 17, 2016

First Posted

March 3, 2016

Study Start

February 1, 2016

Primary Completion

May 30, 2018

Study Completion

February 1, 2019

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

US(1)