Pilot Testing Dementia-Enhanced Training and Tool for Home Hospice Clinicians

NCT ID: NCT05719077

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-06

Study Completion Date

2025-12-24

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease and Related Dementias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Group

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).

Group Type EXPERIMENTAL

EDITH-HC

Intervention Type BEHAVIORAL

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.

Control Group

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).

Group Type OTHER

EDITH-HC

Intervention Type BEHAVIORAL

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.

Interventions

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EDITH-HC

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth A. Luth, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Luth, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers University

Locations

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Rutgers Univeristy

New Brunswick, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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R00AG065624

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro2021001817

Identifier Type: -

Identifier Source: org_study_id

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