Persons With Dementia and Their Extended Family Caregivers (CareEx)

May 23, 2023 updated by: Karen Roberto

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yancey Crawford, MPH
  • Phone Number: 540-231-7962
  • Email: yanceyc3@vt.edu

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Blacksburg, Virginia, United States, 24061
        • Recruiting
        • Virginia Polytechnic Institute and State University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 1 to Day 8
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.
Baseline
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.
Baseline
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.
Baseline
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.
Day 1 to Day 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karen Roberto

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Karen A Roberto, PhD, Virginia Polytechnic Institute and State University
  • Principal Investigator: Jyoti Savla, PhD, Virginia Polytechnic Institute and State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2021

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 24, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-742
  • R01AG069818 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not applicable; will not be sharing individual participant data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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