Persons With Dementia and Their Extended Family Caregivers

NCT ID: NCT04863859

Last Updated: 2025-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-11

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia Dementia Alzheimers Neuro-Degenerative Disease Dementia of Alzheimer Type Dementia Severe

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Grandchildren

Granddaughter or Grandson of the person living with dementia who serves as the primary caregiver

No interventions assigned to this group

Siblings

Brother, sister, brother-in-law or sister-in-law of the person living with dementia who serves as the primary caregiver

No interventions assigned to this group

Nieces/Nephews

Niece or nephew of the person living with dementia who serves as the primary caregiver

No interventions assigned to this group

Step-Kin

Step-kin (step-daughter, step-son, step-sister, step-brother or other step-kin) of the person living with dementia who serves as the primary caregiver

No interventions assigned to this group

Adult Child

Adult child (son or daughter) of the person living with dementia who serves as the primary caregiver

No interventions assigned to this group

Spouse

Spouse (husband or wife) of the person living with dementia who serves as the primary caregiver

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Speaks/reads English
* Resident of Virginia, North Carolina, Maryland, West Virginia, Tennessee, Kentucky or Washington, D.C.
* Age 18+
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Karen Roberto

OTHER

Sponsor Role lead

Responsible Party

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Karen Roberto

University Distinguished Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karen A Roberto, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Jyoti Savla, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Polytechnic Institute and State University

Locations

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Virginia Polytechnic Institute and State University

Blacksburg, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yancey Crawford, MPH

Role: CONTACT

540-231-7962

Brandy McCann, PhD

Role: CONTACT

Facility Contacts

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Yancey Crawford, MPH

Role: primary

540-231-7962

Brandy McCann, PhD

Role: backup

Related Links

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https://careex.isce.vt.edu/

CareEx Study Website

Other Identifiers

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R01AG069818

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-742

Identifier Type: -

Identifier Source: org_study_id

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