Alzheimer's Disease and Related DementiasEDITH-HCNCT05719077
Pilot Testing Dementia-Enhanced Training and Tool for Home Hospice Clinicians
A study testing EDITH-HC in people with Alzheimer's Disease and Related Dementias, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to pilot test the feasibility, acceptability, and preliminary efficacy of a clinically useful, inclusive dementia-enhanced training and tool for use by home hospice clinicians to improve care and support for Black and White patients with dementia and their family caregivers. Read more about this study
- Who is it for?
- Ages 19 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease and Related Dementias
- What is being tested?
- EDITH-HC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2023to 24 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals are not excluded from this study based on gender.
- Based on proportion of hospice workforce and family caregivers that are female, we expect 70%-80% of participants will be female.
- Nurse, social worker, or family member who provides care to persons(s) living with dementia enrolled in home hospice care.
- 19-90 years old.
- Can complete data collection in English.
- Family Caregivers: identify as White or Black/African American.
Who cannot join
- Participant is less than 19 years old or older than 90 years old.
- Does not provide care to person(s) living with dementia enrolled in home hospice.
- Cannot complete data collection in English.
- Family Caregiver does not identify as White or Black/African American.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study 3. Pilot Testing Feasibility, Acceptability, and Preliminary Efficacy of a Dementia-Enhanced Training and Tool for Home Hospice Clinicians in a Clinical Setting.
The purpose of this study is to pilot test the feasibility, acceptability, and preliminary efficacy of a clinically useful, inclusive dementia-enhanced training and tool for use by home hospice clinicians to improve care and support for Black and White patients with dementia and their family caregivers. The investigators expect family caregivers of clinicians in the intervention group will report less caregiver burden (primary outcome) than caregivers of clinicians in the control group. The investigators expect that, compared to clinicians in the control group (usual care), clinicians in the intervention group (receive the training and use the tool) will demonstrate more knowledge of dementia-related caregiving issues (secondary outcomes). In exploratory analyses, the investigators expect family caregivers will report greater self-efficacy and preparedness, and that patients of clinicians in the intervention group will experience fewer live discharges than family caregivers of patients of clinicians in the control group.
Read the detailed description
For this aim, the investigators will conduct a randomized pilot study to determine the feasibility and acceptability of implementing the training and tool in clinical practice compared to usual care with 40 clinicians (20 intervention, 20 control) and 160 Black and white FCG (80 intervention, 80 control). The investigators will also determine preliminary efficacy of the training and tool. Outcomes include feasibility and acceptability of the intervention, reducing FCG burden (primary outcome), improving clinician knowledge and confidence (secondary outcomes) and increasing FCG preparedness and self-efficacy.
- Being tested
- EDITH-HC
- Keywords
- Dementia, End of life, Hospice, Caregiver Burden, Caregiving
- Medical subject headings
- Alzheimer Disease, Dementia, Death, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDITH-HCBehavioural
This study tests feasibility and acceptability of implementing a tool and training in a clinical practice and the preliminary efficacy of training materials to enhance hospice clinicians' knowledge of dementia-related caregiving issues at end of life and a tool for clinicians to use to address caregiving issues related to dementia at end of life.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Clinicians in intervention group will watch a series educational and instructional videos and use caregiver burden assessment tool up to four times during regular home visits with family caregivers of home hospice patients living with dementia. Clinicians will be assessed for changes in knowledge regarding dementia caregiving (secondary outcome). Family caregivers will be assessed for changes in caregiver burden (primary outcome) and preparedness and self-efficacy (exploratory outcomes). Receives: Behavioral: EDITH-HC |
| Control Group | Other | Clinicians in control group will listen to a presentation on outcomes for home hospice patients living with dementia. Clinicians will be assessed for changes in knowledge regarding dementia caregiving (secondary outcome). Family caregivers will be assessed for changes in caregiver burden (primary outcome) and preparedness and self-efficacy (exploratory outcomes). Receives: Behavioral: EDITH-HC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Caregiver Burden
The investigators will assess this outcome using the validated, 12-item Zarit Caregiver Burden Inventory. Summed scores range from 0-48, with higher scores indicating greater burden.
The investigators will assess changes in reported caregiver burden between baseline and the first subsequent hospice visit and compare differences in changes between the intervention and control groups. Because family caregiver participants are relatives of hospice patients that may die (at which point they will no longer be receiving home visits from nurses and social workers), the investigators expect that many participants will not complete all four time points of data collection.
Measured: Baseline and through first subsequent hospice visit, an average of 8 weeks
Secondary outcomes (1)
Clinician Knowledge of Dementia-related Issues at End of Life
The investigators will assess clinician knowledge of dementia-related issues at end of life using the validated, revised Dementia Knowledge Assessment Scale. The DKAS is a 25-item questionnaire, summed range: 0=50, with higher scores indicating greater knowledge.
The investigators will assess changes in reported knowledge between baseline and after completing the training. The investigators will compare differences in changes between clinicians receiving the training (intervention) and those receiving a presentation on patterns of hospice outcomes for persons living with dementia (control).
Measured: Baseline and through training completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start6 Oct 2023
- Primary completion30 Jun 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's Disease and Related DementiasStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Nurses and social workers are organized into interdisciplinary teams (IDTs) based on geographic location. Patients and families in those geographic are assigned to clinicians' individual caseloads. The investigators will randomize up to 14 IDTs of 6-8 clinicians each to the intervention and control groups. Six teams will be randomized at the beginning of the study. The remaining 8 teams will be adaptively randomized as they enter the study to maintain balance between the number of Black and White family caregiver participants in each arm. Family caregivers will be assigned to the same group (intervention or control) as the clinician they are assigned to. IDT assignment to intervention and control groups will be balanced based on characteristics including patients' racial/ethnic group membership and neighborhood socioeconomic status.
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Elizabeth A. Luth, PhD, Rutgers, The State University of New Jersey
- Investigators
- Elizabeth Luth, PhD, Principal investigator, Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719077
- Sponsor's protocol ID
- Pro2021001817
- Other IDs
- R00AG065624
- Acronym
- EDITH-HC
- Status last verified
- Jul 2026
- First submitted
- 20 Jan 2023
- Last updated
- 16 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study 3. Pilot Testing Feasibility, Acceptability, and Preliminary Efficacy of a Dementia-Enhanced Training and Tool for Home Hospice Clinicians in a Clinical Setting.
- ClinicalTrials.gov ID
- NCT05719077
- Acronym / sponsor ID
- EDITH-HC / Pro2021001817
- Keywords
- Dementia, End of life, Hospice, Caregiver Burden, Caregiving
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Posted 16 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to pilot test the feasibility, acceptability, and preliminary efficacy of a clinically useful, inclusive dementia-enhanced training and tool for use by home hospice clinicians to improve care and support for Black and White patients with dementia and their family caregivers. The investigators expect family caregivers of clinicians in the intervention group will report less caregiver burden (primary outcome) than caregivers of clinicians in the control group. The investigators expect that, compared to clinicians in the control group (usual care), clinicians in the intervention group (receive the training and use the tool) will demonstrate more knowledge of dementia-related caregiving issues (secondary outcomes). In exploratory analyses, the investigators expect family caregivers will report greater self-efficacy and preparedness, and that patients of clinicians in the intervention group will experience fewer live discharges than family caregivers of patients of clinicians in the control group.
Detailed description
For this aim, the investigators will conduct a randomized pilot study to determine the feasibility and acceptability of implementing the training and tool in clinical practice compared to usual care with 40 clinicians (20 intervention, 20 control) and 160 Black and white FCG (80 intervention, 80 control). The investigators will also determine preliminary efficacy of the training and tool. Outcomes include feasibility and acceptability of the intervention, reducing FCG burden (primary outcome), improving clinician knowledge and confidence (secondary outcomes) and increasing FCG preparedness and self-efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Nurses and social workers are organized into interdisciplinary teams (IDTs) based on geographic location. Patients and families in those geographic are assigned to clinicians' individual caseloads. The investigators will randomize up to 14 IDTs of 6-8 clinicians each to the intervention and control groups. Six teams will be randomized at the beginning of the study. The remaining 8 teams will be adaptively randomized as they enter the study to maintain balance between the number of Black and White family caregiver participants in each arm. Family caregivers will be assigned to the same group (intervention or control) as the clinician they are assigned to. IDT assignment to intervention and control groups will be balanced based on characteristics including patients' racial/ethnic group membership and neighborhood socioeconomic status.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: EDITH-HCClinicians in intervention group will watch a series educational and instructional videos and use caregiver burden assessment tool up to four times during regular home visits with family caregivers of home hospice patients living with dementia. Clinicians will be assessed for changes in knowledge regarding dementia caregiving (secondary outcome). Family caregivers will be assessed for changes in caregiver burden (primary outcome) and preparedness and self-efficacy (exploratory outcomes). |
| Control Group | Other | Behavioral: EDITH-HCClinicians in control group will listen to a presentation on outcomes for home hospice patients living with dementia. Clinicians will be assessed for changes in knowledge regarding dementia caregiving (secondary outcome). Family caregivers will be assessed for changes in caregiver burden (primary outcome) and preparedness and self-efficacy (exploratory outcomes). |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals are not excluded from this study based on gender.
- Based on proportion of hospice workforce and family caregivers that are female, we expect 70%-80% of participants will be female.
- Nurse, social worker, or family member who provides care to persons(s) living with dementia enrolled in home hospice care.
- 19-90 years old.
- Can complete data collection in English.
Key exclusion criteria (4 listed)
- Participant is less than 19 years old or older than 90 years old.
- Does not provide care to person(s) living with dementia enrolled in home hospice.
- Cannot complete data collection in English.
- Family Caregiver does not identify as White or Black/African American.
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 |
|---|---|---|
| EDITH-HCThis study tests feasibility and acceptability of implementing a tool and training in a clinical practice and the preliminary efficacy of training materials to enhance hospice clinicians' knowledge of dementia-related caregiving issues at end of life and a tool for clinicians to use to address caregiving issues related to dementia at end of life. | Behavioural | Control Group, Intervention Group |
Primary outcome
Family Caregiver Burden
Time frame: Baseline and through first subsequent hospice visit, an average of 8 weeks
The investigators will assess this outcome using the validated, 12-item Zarit Caregiver Burden Inventory. Summed scores range from 0-48, with higher scores indicating greater burden. The investigators will assess changes in reported caregiver burden between baseline and the first subsequent hospice visit and compare differences in changes between the intervention and control groups. Because family caregiver participants are relatives of hospice patients that may die (at which point they will no longer be receiving home visits from nurses and social workers), the investigators expect that many participants will not complete all four time points of data collection.
1 secondary outcome
Clinician Knowledge of Dementia-related Issues at End of Life
Time frame: Baseline and through training completion, an average of 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Elizabeth Luth, PhD principal investigator
Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDITH-HC in people with Alzheimer's Disease and Related Dementias, run by Rutgers, The State University of New Jersey 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 16 Jul 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?
Yes. Results are posted in the registry (first posted 16 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Caregiver Burden (time frame: Baseline and through first subsequent hospice visit, an average of 8 weeks). 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 16 Jul 2026.