Clinical trial NCT04939714: Caregiving During Crisis
Official title: Mastering the Challenges of Dementia Family Caregiving in a Time of COVID-19: An Online Course
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Stress Syndrome
Keywords: Dementia family caregiver
Online education
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will test a prototype pandemic caregiver training and education course designed for caregivers of persons living with dementia (PLWD). Participants will be randomized to take the course immediately or to take the course after completion of an 8-week waiting period.

Detailed description: Family caregivers, the backbone of care for the upwards of 7 million community-dwelling individuals living with Alzheimer's disease in the U.S., provide at least 85% of the care these individuals receive, at some risk to their own well-being, and are instrumental in navigating healthcare systems. Without their care, it is almost certain that persons living with dementia (PLWD) would have much higher rates of acute and emergency care use than their age-matched peers, perilous venues for them in the best of times, potentially deadly during this pandemic. With coronavirus disease 2019 (COVID-19) restrictions, the amount of care they provide and the expertise needed to provide the care will increase. Typically, caregivers are strangers in healthcare and pandemic landscapes, but they are now called on to enact home care and safety measures and navigate an intricate, complex, and opaque system without the benefit of a compass or a translator, and largely without understanding their role in or having the skills for navigating the system. A variety of interventions have demonstrated benefit in enhancing caregivers' caregiving capacities, with resulting positive outcomes for both caregivers and care recipients. Only a few of these useful interventions, Tele-Savvy among them, have employed distance delivery means, thus enabling rural caregivers and others precluded by circumstance from attending in-person programs to take part in the intervention programs.

The study will assess a psychoeducational intervention for dementia caregivers. Participating caregivers will be randomized to immediately enroll in the study intervention or to be in a waitlist group that will begin the intervention 8 weeks later. Participants will complete interviews at baseline and after the 8-week study period.

Eligibility criteria: Inclusion Criteria:

* Providing care for a family member or friend with a confirmed diagnosis of dementia
* Lives in the community
* Co-resides with the PLWD
* Is the main caregiver for the PLWD
* Has access to a computer with internet service
* Can read and understand English

Exclusion Criteria:

* None

Primary outcomes:
measure: Center for Epidemiologic Studies - Depression (CES-D) Scale Score
timeFrame: Baseline, Week 8
measure: State-Trait Anxiety Inventory (STAI) Score
timeFrame: Baseline, Week 8
measure: Perceived Stress Scale (PSS-14) Score
timeFrame: Baseline, Week 8
measure: Revised Memory and Behavior Problem Checklist (RMBPC) Frequency Score
timeFrame: Baseline, Week 8
measure: Revised Memory and Behavior Problem Checklist (RMBPC) Reaction Score
timeFrame: Baseline, Week 8
measure: Zarit Burden Interview Score
timeFrame: Baseline, Week 8
measure: Caregiver Mastery Scales - Competency Score
timeFrame: Baseline, Week 8
measure: Caregiver Assessment of Behavioral Skill - Self-report Score
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Carolyn Clevenger, DNP, APRN
role: PRINCIPAL_INVESTIGATOR
References: