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

NCT05719077 | Completed

• 2 other identifiers: Pro2021001817R00AG065624
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer's Disease and Related Dementias

Keywords

Dementia; End of life; Hospice; Caregiver Burden; Caregiving

Outcome Measures

Primary Outcomes (1)

• Family Caregiver Burden

  The investigators will assess this outcome using the validated, 12-item Zarit Caregiver Burden Inventory. The investigators will assess changes in reported caregiver burden between baseline and the frist 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.

  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

  Baseline and through training completion, an average of 4 weeks

Other Outcomes (3)

• Family caregiver self-efficacy (exploratory)

  Baseline and through first subsequent hospice visit, an average of 8 weeks

• Family caregiver preparedness (exploratory)

  Baseline and through first subsequent hospice visit, an average of 8 weeks

• Patient hospice discharge status (exploratory)

  3 months post-intervention, 6 months post-intervention

Study Arms (2)

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).

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).

Behavioral: EDITH-HC

Interventions

EDITH-HC 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; Intervention Group

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years old.
• Can complete data collection in English.
• Family Caregivers: identify as White or Black/African American.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Rutgers Univeristy

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Death; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Elizabeth Luth, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2023
• First Posted: February 8, 2023
• Study Start: October 6, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 24, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)