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Clinical Trials/NCT04863859
NCT04863859
Recruiting
Not Applicable

Persons With Dementia and Their Extended Family Caregivers: Service Use, Barriers and Needs

Karen Roberto1 site in 1 country360 target enrollmentSeptember 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Karen Roberto
Enrollment
360
Locations
1
Primary Endpoint
Well-Being of Caregiver: Work Strain
Status
Recruiting
Last Updated
7 months ago

Overview

Brief Summary

Immediate family members shoulder the majority of care responsibilities for persons living with dementia. However, due to various societal changes, elder care responsibilities have expanded to extended family members, including grandchildren, siblings, nieces/nephews, siblings, and step-kin.

The main objective of this study is to understand the caregiving journeys of various extended family members involved in dementia care. We aim to learn about caregivers' care management strategies; their use of home and community-based services and informal support; and barriers to service usage. We will use the results from the study to help enhance service delivery, alleviate care-related stress, and improve the quality of life of dementia patients and their caregivers.

We will use a mixed-methods design to explore the challenges faced by caregivers as well as their service usage for the person living with dementia. Our methodology involves an initial telephone interview (approx. 70 minutes) that includes open-ended questions, standard items, and structured measures, followed by an 8-day semi-structured daily diary interview about daily care responsibilities and experiences with services (15-20 minutes each evening). This study will be conducted with 240 extended family members serving as one of the main caregivers for a person living with dementia in a community setting.

Registry
clinicaltrials.gov
Start Date
September 11, 2021
End Date
December 1, 2026
Last Updated
7 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Karen Roberto
Responsible Party
Sponsor Investigator
Principal Investigator

Karen Roberto

University Distinguished Professor

Virginia Polytechnic Institute and State University

Eligibility Criteria

Inclusion Criteria

  • Speaks/reads English
  • Resident of Virginia, North Carolina, Maryland, West Virginia, Tennessee, Kentucky or Washington, D.C.
  • Is either the grandchild, sibling, niece/nephew, step-kin, adult child or spouse of the person living with dementia
  • Is providing hands-on care and/or overall management of care for a person living with dementia in the community
  • Caregiver co-resides with the person with dementia or has face-to-face contact with the person with dementia at least 3 days/week
  • Has no difficulty talking/hearing on the telephone

Exclusion Criteria

  • Caregiver of persons with mild cognitive impairment
  • Person with dementia lives in service-enriched housing such as a continuing care community, or residential facilities, such as assisted living facilities or nursing homes

Outcomes

Primary Outcomes

Well-Being of Caregiver: Work Strain

Time Frame: Baseline

CG who are employed will be asked 5 work strain items that assess competing demands and strains between CG and employment outside the home. Participants rate their responses on a 4-point scale ("strongly agree" to "strongly disagree"). Summary scores range from 0 to 15, higher scores indicate greater work strain.

Change in Well-Being of Person Living with Dementia

Time Frame: Day 1 to Day 8

The caregiver (CG) will be asked to indicate who helped the person living with dementia (PLwD) each of the daily diary days with personal activities of daily living and instrumental activities of daily living for which they need help. CG will also be asked if there were any activities for which the PLwD needed help that day but did not receive it because no one was there to help them (PLwD Unmet Need), or they delayed receiving help or received partial help because no one was available to help them when needed (PLwD Under-met Need).

Well-Being of Caregiver: Role Captivity

Time Frame: Baseline

Role captivity, a 3-item scale that assesses CG feelings that their involvement exceeds what they are willing to provide. Participants rate their responses on a 4-point scale ("not at all" to "very much"). Summary scores range from 0 to 9, higher scores indicate greater role captivity.

Change in Caregiver Daily Psychological Distress

Time Frame: Day 1 to Day 8

Using the daily version of the Non-Specific Psychological Distress Scale, each day, the caregiver will indicate how frequently they felt 14 negative/13 positive emotions over the past 24 hours on a 5-point scale from "none" to "all" of the time.

Well-Being of Caregiver: Role overload

Time Frame: Baseline

Role overload, a 3-item scale will assess CG subjective appraisal of the time and effort they make in providing care. Participants rate their responses on a 4-point scale ("not at all" to "completely"). Summary scores range from 0 to 9, higher scores indicate greater role overload.

Study Sites (1)

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