Pilot Testing Dementia-Enhanced Training and Tool for Home Hospice Clinicians (EDITH-HC)

March 26, 2024 updated by: Elizabeth A. Luth, PhD, Rutgers, The State University of New Jersey

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Rutgers Univeristy
        • Contact:
        • Principal Investigator:
          • Elizabeth Luth, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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.
Other: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family Caregiver Burden
Time Frame: Baseline and through intervention completion, an average of 8 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician knowledge of dementia-related issues at end of life
Time Frame: Baseline and through training completion, an average of 4 weeks
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Family caregiver self-efficacy (exploratory)
Time Frame: Baseline and through intervetion completion, an average of 8 weeks
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
Family caregiver preparedness (exploratory)
Time Frame: Baseline and through intervention completion, an average of 8 weeks
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
Patient hospice discharge status (exploratory)
Time Frame: 3 months post-intervention, 6 months post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Elizabeth Luth, PhD, Rutgers University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2023

Primary Completion (Estimated)

September 15, 2024

Study Completion (Estimated)

March 28, 2025

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (Actual)

February 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2021001817
  • R00AG065624 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease and Related Dementias

Clinical Trials on EDITH-HC

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe