Caregiving During Crisis

NCT ID: NCT04939714

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-07
• Study Completion Date: 2022-08-15

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.

Conditions

Caregiver Stress Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Psychoeducational Intervention

Caregivers receiving the psychoeducational intervention immediately.

Group Type: EXPERIMENTAL

Psychoeducational Intervention

Intervention Type: BEHAVIORAL

The intervention is an online course providing education and training to caregivers over an 8 week period. The self-paced course provides information on caregiving for a PLWD during a pandemic, navigating the health care system for a PLWD, and managing daily life (including self-care).

Waitlist

Caregivers on a waitlist to receive the psychoeducational intervention after a waiting period of 8 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychoeducational Intervention

The intervention is an online course providing education and training to caregivers over an 8 week period. The self-paced course provides information on caregiving for a PLWD during a pandemic, navigating the health care system for a PLWD, and managing daily life (including self-care).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Carolyn Clevenger

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carolyn Clevenger, DNP, APRN

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

3P30AG064200-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001424

Identifier Type: -

Identifier Source: org_study_id