Shared CareNCT07227558
Improving Information Sharing Between Family Caregivers and Home Care Aides
A study testing GRACE in people with Shared Care, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shared Care
- What is being tested?
- GRACE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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:
- 18 years and older
- English speaking
- hear well enough to communicate by telephone
- identify themselves as the primary family member or unpaid (friend/companion) caregiver
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21205
Chanee Fabius, PhD
Valecia Hanna, MS
About this study
Official title: Improving Information Sharing Between Family Caregivers and Home Care Aides Caring for Persons Living With ADRD
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.
Read the detailed description
This study will assess the feasibility and acceptability of delivering a home care role and preference guide to family caregivers and home care aides of persons living with disability for the purpose of identifying roles between family caregivers and home care aides, as well as preliminary effects on older adult social engagement, caregiver distress, continuity, and feelings of being overwhelmed, family caregiver/direct care worker preparedness, relational coordination, and service satisfaction. The intervention will involve delivering the home care role and preference guide to up to 50 family caregiver-home care care aide dyads to demonstrate the feasibility of collecting primary endpoints relating to older adults' outcomes to be examined in a future ePCT as well as intervention acceptability. Information about family caregivers and home care aide perspectives will be collected at enrollment, 2- and 4-weeks of the intervention.
- Conditions
- Shared Care
- Being tested
- GRACE
- Keywords
- Shared Care, Family Caregiving, Paid Caregiving
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| GRACE | Other | Role and preference guide for family caregivers and home care aides Receives: Other: GRACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start14 Apr 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shared CareStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Chanee Fabius, PhD, Principal investigator, Johns Hopkins University Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07227558
- Sponsor's protocol ID
- IRB00022916
- Other IDs
- 5K01AG080079-03
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2025
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Information Sharing Between Family Caregivers and Home Care Aides Caring for Persons Living With ADRD
- ClinicalTrials.gov ID
- NCT07227558
- Acronym / sponsor ID
- IRB00022916
- Conditions
- Shared Care
- Keywords
- Shared Care, Family Caregiving, Paid Caregiving
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will assess the feasibility and acceptability of delivering a home care role and preference guide to family caregivers and home care aides of persons living with disability for the purpose of identifying roles between family caregivers and home care aides, as well as preliminary effects on older adult social engagement, caregiver distress, continuity, and feelings of being overwhelmed, family caregiver/direct care worker preparedness, relational coordination, and service satisfaction. The intervention will involve delivering the home care role and preference guide to up to 50 family caregiver-home care care aide dyads to demonstrate the feasibility of collecting primary endpoints relating to older adults' outcomes to be examined in a future ePCT as well as intervention acceptability. Information about family caregivers and home care aide perspectives will be collected at enrollment, 2- and 4-weeks of the intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| GRACE | Other | Other: GRACERole and preference guide for family caregivers and home care aides |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Home care agency aide:
- Family or unpaid caregiver eligible for the study if:
Key exclusion criteria (9 listed)
- Home care aides are ineligible if:
- Family/unpaid caregivers ineligible if:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GRACEGRACE- 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. | Other | GRACE |
Primary outcome
Acceptability as assessed by survey
Time frame: 2 week and 4 weeks
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.
Feasibility as assessed by survey
Time frame: 2 week and 4 weeks
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.
Low Social Engagement as assessed by survey question
Time frame: Baseline, 2 weeks and 4 weeks
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.
Caregiver is Overwhelmed as assessed by survey question
Time frame: Baseline, 2 weeks and 4 weeks
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.
Caregiver Distress assessed by survey question
Time frame: Baseline, 2 weeks and 4 weeks
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.
Caregiver Continuity assessed by survey item
Time frame: Baseline, 2 weeks and 4 weeks
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.
Caregiver Preparedness assessed by The Caregiving Preparedness Scale (CPS)
Time frame: Baseline, 2 weeks and 4 weeks
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.
Relational Coordination assessed by survey
Time frame: Baseline, 2 weeks and 4 weeks
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.
Direct Care Worker Job Satisfaction assessed by survey question
Time frame: Baseline, 2 weeks and 4 weeks
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.
Number of participants with new Direct Care Worker
Time frame: 2 weeks and 4 weeks
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chanee Fabius, PhD principal investigator
Johns Hopkins University Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GRACE in people with Shared Care, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valecia Hanna, MS (4432202389, vhanna1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability as assessed by survey (time frame: 2 week and 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.