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

Alzheimer's Disease and Related Dementias Clinical Trial

— EDITH-HC  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05719077
• Other study ID #: Pro2021001817
• Secondary ID: R00AG065624
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: May 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Elizabeth Luth, PhD
• Phone: 646-512-0670
• Email: eal133[@]ifh.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 28, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease and Related Dementias
• Dementia

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Rutgers Univeristy	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Family caregiver self-efficacy (exploratory)	The investigators will assess caregiver self-efficacy using the validated, 8-item Caregiver Self-Efficacy Scale (CSES). The investigators will assess changes in caregiver self-efficacy between baseline and subsequent hospice visits and compare differences in changes between the intervention and control groups. The same issues due to attrition described in 1. Family Caregiver burden above also apply here.	Baseline and through intervetion completion, an average of 8 weeks
Other	Family caregiver preparedness (exploratory)	The investigators will assess caregiver preparedness for dementia caregiving using a single-item question about the extent to which caregivers feel prepared to provide care to their loved one and the 9-item Preparedness Scale of the Family Care Inventory. The investigators will assess changes at baseline and subsequent hospice visits and compare differences in changes between the intervention and control groups. The same issues due to attrition described in 1. Family Caregiver burden above also apply here.	Baseline and through intervention completion, an average of 8 weeks
Other	Patient hospice discharge status (exploratory)	The investigators will assess patient status upon hospice discharge as either deceased or alive. The investigators will assess patient discharge status as reported in the electronic hospice records. The investigators will compare discharge status of hospice patients with study-enrolled caregivers between intervention and control groups.	3 months post-intervention, 6 months post-intervention
Primary	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 subsequent hospice visits 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 intervention completion, an average of 8 weeks
Secondary	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 a revised Dementia Knowledge Assessment Scale and assessment questions that are tailored to the content of the training. 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).	Baseline and through training completion, an average of 4 weeks