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OpenTrials
Completed

NCT Number: NCT04863859

Persons With Dementia and Their Extended Family Caregivers

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.

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Key information

Conditions

Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Alzheimers Dementia Severe Dementia of Alzheimer Type Mental Disorders Nervous System Diseases Neuro-Degenerative Disease Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Karen Roberto

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: CareEx

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2021
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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