NCT07227558

Brief Summary

This study will assess the feasibility and acceptability of delivering a home care role and preference guide to up to 50 family caregivers and home care aides of persons living with disability for the purpose of identifying roles between family caregivers and home care aides.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 12, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

November 10, 2025

Last Update Submit

March 16, 2026

Conditions

Keywords

Shared CareFamily CaregivingPaid Caregiving

Outcome Measures

Primary Outcomes (10)

  • Acceptability as assessed by survey

    Participants will be asked to rate their overall feedback of the role and preference guide. Participants will be asked how often they used the guide since the last study time point using a scale from 1 to 5 (1=Never, 2=Rarely, 3=Occasionally, 4= Often, 5 Constantly) where higher scores indicate greater frequency of use.

    2 week and 4 weeks

  • Feasibility as assessed by survey

    Participants will be asked about how helpful the guide was using a scale from 1 to 5:1=Not helpful at all, 2=Not too helpful, 3=Somewhat helpful, 4=Pretty helpful, 5=Very helpful, where higher scores indicate more helpful. More affirmative responses indicate better feasibility of the guide.

    2 week and 4 weeks

  • Low Social Engagement as assessed by survey question

    Low social engagement measures an older adult's ability to participate in social activities of longstanding interest reported by the caregiver. This item is measured on a scale from 0-3 (0=Occurred in the last 3 days, 1=Occurred within the last week, 2=Occurred within the last month, 3=Last occurred more than one month ago) where higher scores mean lesser ability to participate in social activities.

    Baseline, 2 weeks and 4 weeks

  • Caregiver is Overwhelmed as assessed by survey question

    Caregivers' feelings of being overwhelmed measures how often a caregiver is overwhelmed by aspects of caregiving responsibilities and older adults' illness. This item is measured using a scale from 1-5 (1=Never, 2=Rarely, 3=Occasionally, 4=Often, 5= Constantly) where higher scores mean greater feelings of being overwhelmed.

    Baseline, 2 weeks and 4 weeks

  • Caregiver Distress assessed by survey question

    Caregivers' feelings of distress measures how often a caregiver is distressed by aspects of caregiving responsibilities and older adults' illness. This item is measured using a scale from 1-5 (1=Never, 2=Rarely, 3=Occasionally, 4=Often, 5= Constantly) where higher scores mean greater feelings of distress.

    Baseline, 2 weeks and 4 weeks

  • Caregiver Continuity assessed by survey item

    Caregivers continuity measures how feelings on inability to continue caregiving. This item is measured using a scale from 1-5 (1=Never, 2=Rarely, 3=Occasionally, 4=Often, 5= Constantly) where higher scores mean greater feelings of distress.

    Baseline, 2 weeks and 4 weeks

  • Caregiver Preparedness assessed by The Caregiving Preparedness Scale (CPS)

    The Caregiving Preparedness Scale (CPS) is an 8-item uni-dimensional instrument that evaluates the extent to which a caregiver and direct care worker feels prepared to meet the psychological and physical needs of a patient (client). The scale was originally developed for family caregivers and has been used to assess caregiver preparedness in direct care workers in prior work. Responses are categorized with a 5-level likert scale: Not at all prepared; not too prepared; somewhat well prepared; pretty well prepared; very well prepared. The total scale score, which is a mean of all items scores, ranges between 0 and 4 with higher score indicating better preparedness.

    Baseline, 2 weeks and 4 weeks

  • Relational Coordination assessed by survey

    Relational coordination suggests that effective coordination occurs through frequent, high-quality communication that is supported by relationships of shared goals, shared knowledge, and mutual respect. Its measurement has been applied across several settings, including home care. Family caregivers and direct care workers will rate interactions with each other along three dimensions, with seven questions on a five-point scale related to the components of relational coordination. Four items related to communication include: frequency, timeliness, accuracy, and problem-solving. Three items measured relationships: shared knowledge, goals, and respect for each other. The mean of each of the seven items is calculated for each group (family caregivers and direct care workers). The total score for all items ranges from 7 to 35 where higher scores indicate better coordination and communication among family caregiver and direct care worker.

    Baseline, 2 weeks and 4 weeks

  • Direct Care Worker Job Satisfaction assessed by survey question

    Job satisfaction measures the direct care worker's overall job satisfaction on a scale from 1-4 (1= Very dissatisfied, 2=Dissatisfied, 3=Satisfied, 4=Very Satisfied). Higher score is better.

    Baseline, 2 weeks and 4 weeks

  • Number of participants with new Direct Care Worker

    Direct Care Worker Turnover measure changes in the enrolled direct care worker participant in the study from the time baseline is completed to study endpoint at 4 weeks. Caregivers will be asked if the direct care worker left and at what time point in the study, and if the participant was assigned or hired a new worker. This will be measured using affirmative responses (yes or no).

    2 weeks and 4 weeks

Study Arms (1)

GRACE

OTHER

Role and preference guide for family caregivers and home care aides

Other: GRACE

Interventions

GRACEOTHER

GRACE- Guide for Role Awareness and Care Engagement is a role and preference guide designed to improve information sharing and clarify role expectations between family caregivers and home care aides of older adults. This guide will outline the various domains of providing care services and preferences for older adults such as daily routine and preferred activities. The intervention will be delivered in-person to the family caregiver and home care aide at the care recipient's home.

GRACE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Home care agency aide:
  • English speaking,
  • home care aides, personal care aides, or personal care aides, providing services to older adults with ADRD.
  • Family or unpaid caregiver eligible for the study if:
  • years and older
  • English speaking
  • hear well enough to communicate by telephone
  • identify themselves as the primary family member or unpaid (friend/companion) caregiver

You may not qualify if:

  • Home care aides are ineligible if:
  • non-English speaking
  • certified nursing assistants, nursing assistant, home health aides, or medication technicians.
  • Family/unpaid caregivers ineligible if:
  • less than 18 years old
  • non-English speaking
  • do not hear well enough to communicate by telephone
  • two or more incorrect answers or not being able to respond to a validated 6-item telephone screening instrument
  • are not identified as the person's primary caregiver, or are paid for services.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

RECRUITING

Study Officials

  • Chanee Fabius, PhD

    Johns Hopkins University Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Valecia Hanna, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: The interventional study model will include a home care role and preference guide to improve information sharing and clarify role expectations between family caregivers and home care aides of older adults with disabilities.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2025

First Posted

November 12, 2025

Study Start

April 15, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 17, 2026

Record last verified: 2026-03

Locations