The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL)

The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL)

Alzheimer's Disease and Related Disorders (dementia) are a group of serious life limiting illness that cause significant challenges to our public health system, with significant illness burden for both the person with dementia and the caregiver. At the end of life, over 230,000 persons with dementia annually are cared for in hospice, yet hospice agencies are ill prepared to care for this population and often resort to inappropriate pharmacologic measures such as antipsychotics that reduce quality of life rather than improve it. This study will therefore through its two phases refine and then implement, using a pragmatic stepped wedge trial design, the Dementia Symptom Management at Home Program Hospice Edition, with the goal improving quality of care for the person with dementia and their caregiver, reducing antipsychotic use, and increasing bereaved caregiver satisfaction in the hospice setting.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Dementia symptom management at home hospice edition; Behavioral: Education and Training

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Must have dementia as primary diagnosis for admission to hospice
• Must be newly admitted to a participating hospice
• Must be 50 years or older

Clinicians:

• Must be a skilled clinician or home health aide who provides care through an eligible home health agency
• Must be 18 years or older

Exclusion Criteria:

Persons with Dementia:

• None

Clinicians:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Advanced Demential Patients	Behavioral: Dementia symptom management at home hospice edition; Quality assurance performance improvement program
Experimental: Hospice IDT Members	Behavioral: Education and Training; Education and training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Hospice IDT Members Who Complete Required Education and Training	Percentage of Hospice IDT Members who Complete Required Education and Training	2 Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Abraham Brody, PhD, NYU Langone Health

Publications and helpful links

General Publications

• Lin SY, Schneider CE, Bristol AA, Clancy M, Sprague SA, Aldridge M, Cortes T, Goldfeld KS, Kutner JS, Mitchell SL, Shega JW, Wu B, Zhu CW, Brody AA. Findings of Sequential Pilot Trials of Aliviado Dementia Care to Inform an Embedded Pragmatic Clinical Trial. Gerontologist. 2022 Feb 9;62(2):304-314. doi: 10.1093/geront/gnaa220.
• Schneider CE, Bristol A, Ford A, Lin SY, Palmieri J, Meier MR, Brody AA; HAS-QOL Trial Investigators. The Impact of Aliviado Dementia Care-Hospice Edition Training Program on Hospice Staff's Dementia Symptom Knowledge. J Pain Symptom Manage. 2020 Aug;60(2):e7-e13. doi: 10.1016/j.jpainsymman.2020.05.010. Epub 2020 May 15.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2019
• Primary Completion (Actual): June 12, 2019
• Study Completion (Actual): June 12, 2019

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 18-01265

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No