DementiaCareExNCT04863859
Persons With Dementia and Their Extended Family Caregivers
An observational study of Dementia and Dementia Alzheimers, run by Karen Roberto at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Dementia Alzheimers, Neuro-Degenerative Disease
- How many people
- 275 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2021to 31 May 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Polytechnic Institute and State University
Blacksburg, Virginia, 24061
About this study
Official title: Persons With Dementia and Their Extended Family Caregivers: Service Use, Barriers and Needs
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
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 to Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start11 Sep 2021
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Roberto
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Karen Roberto, Virginia Polytechnic Institute and State University
- Investigators
- Karen A Roberto, PhD, Principal investigator, Virginia Polytechnic Institute and State UniversityJyoti Savla, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863859
- Sponsor's protocol ID
- 20-742
- Other IDs
- R01AG069818
- Acronym
- CareEx
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable; will not be sharing individual participant data with other researchers.