Persons With Dementia and Their Extended Family Caregivers

NCT04863859 | Recruiting

• 2 other identifiers: 20-742R01AG069818
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

caregiving, persons living with dementia, community-based services

Outcome Measures

Primary Outcomes (5)

• Change in Well-Being of Person Living with Dementia

  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).

  Day 1 to Day 8

• Well-Being of Caregiver: Role overload

  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.

  Baseline

• Well-Being of Caregiver: Role Captivity

  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.

  Baseline

• Well-Being of Caregiver: Work Strain

  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.

  Baseline

• Change in Caregiver Daily Psychological Distress

  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.

  Day 1 to Day 8

Study Arms (6)

Grandchildren

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

Siblings

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

Nieces/Nephews

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

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

Adult Child

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

Spouse

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes extended family caregivers defined as grandchildren, siblings, nieces/nephews and step-kin of persons living with dementia. Caregivers must be as least 18 years of age and primarily responsible for the hands-on care and/or overall management of care for a person living with dementia living in the community. The study will recruit 60 grandchildren, 60 siblings, 60 nieces/nephews and 60 step-kin care givers; in additional 60 adult child and 60 spouse caregivers will be recruited for comparison purposes.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karen Roberto: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Virginia Polytechnic Institute and State University

Blacksburg, Virginia, 24061, United States

RECRUITING

Related Links

• CareEx Study Website

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Karen A Roberto, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

• Jyoti Savla, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yancey Crawford, MPH

CONTACT

540-231-7962; yanceyc3@vt.edu

Brandy McCann, PhD

CONTACT

bmccann@vt.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University Distinguished Professor

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 28, 2021
• Study Start: September 11, 2021
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)