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Completed

NCT Number: NCT02697721

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.

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Key information

Conditions

Caregivers Alzheimer Disease Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Depression Mental Disorders Motor Activity Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University College of Medicine

Tallahassee, Florida, 32306, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Powerful Tools for Caregivers

Behavioral

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 with delayed intervention

Other

Control with delayed intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

  • Florida Department of Health

Registry information

Official study title

Optimization of "Powerful Tools for Caregivers" of Dementia Patients

Acronym: PTC-dementia

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 3, 2016
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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