Alzheimer Disease Clinical Trial
— PTC-dementiaOfficial title:
Optimization of "Powerful Tools for Caregivers" of Dementia Patients
NCT number | NCT02697721 |
Other study ID # | 6AZ09 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2016 |
Est. completion date | February 2019 |
Verified date | January 2021 |
Source | Florida State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 2019 |
Est. primary completion date | May 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Florida State University College of Medicine | Tallahassee | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida State University | Florida Department of Health |
United States,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Caregiver Burden | Zarit Caregiver Burden Scale scores | 6 weeks | |
Primary | Frequency and reaction to care recipient behavioral and psychological symptoms of dementia | Revised Memory and Behavior Problems Checklist scores | 6 weeks | |
Primary | Frequency of care recipient agitated behaviors | Cohen-Mansfield Agitation Inventory scores | 6 weeks | |
Secondary | Activity parameters as assessed by FitBit | 6 weeks | ||
Secondary | Depressive symptoms | Center for Epidemiologic Studies Depression Scale scores | 6 weeks | |
Secondary | Caregiving Self-Efficacy | Caregiving Self-Efficacy Scale scores | 6 weeks | |
Secondary | Self-rated health | Single item "In general, would you say your health is...." with response options from 1= poor to 5=excellent. | 6 weeks | |
Secondary | Life satisfaction | Single item "I am satisfied with my life" with response options from 0=Strongly disagree to 4=Strongly agree | 6 weeks | |
Secondary | Perceived change | Perceived Change Index score | 6 weeks | |
Secondary | Neuropsychiatric symptoms in care recipients | Neuropsychiatric Inventory score | 6 weeks |
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