Powerful Tools for Caregivers of Dementia Patients

Not Applicable

Completed

• Conditions: Caregivers; Dementia; Alzheimer Disease
• Interventions: Behavioral: Powerful Tools for Caregivers; Other: Control with delayed intervention

• Registration Number: NCT02697721
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-17
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-03
• Primary Completion: 2018-05-30
• Study Completion: 2019-02
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Powerful Tools for Caregivers	Powerful Tools for Caregivers	A 6-week psycho-educational program
Control group, delayed intervention	Control with delayed intervention	Control group with delayed intervention

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Florida State University College of Medicine; 🇺🇸 Tallahassee, Florida, United States