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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dementia symptom management at home hospice edition
Education and Training
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Advanced Demential Patients

Hospice IDT Members

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Hospice IDT Members Who Complete Required Education and Training
Percentage of Hospice IDT Members who Complete Required Education and Training

Secondary Outcome Measures

Full Information

First Posted
September 20, 2018
Last Updated
August 11, 2020
Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03681119
Brief Title
The Hospice Advanced Dementia Symptom Management and Quality of Life Trial
Acronym
HAS-QOL
Official Title
The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 11, 2019 (Actual)
Primary Completion Date
June 12, 2019 (Actual)
Study Completion Date
June 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Advanced Demential Patients
Arm Type
Experimental
Arm Title
Hospice IDT Members
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Dementia symptom management at home hospice edition
Intervention Description
Quality assurance performance improvement program
Intervention Type
Behavioral
Intervention Name(s)
Education and Training
Intervention Description
Education and training
Primary Outcome Measure Information:
Title
Percentage of Hospice IDT Members Who Complete Required Education and Training
Description
Percentage of Hospice IDT Members who Complete Required Education and Training
Time Frame
2 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Brody, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33377138
Citation
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.
Results Reference
derived
PubMed Identifier
32416231
Citation
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.
Results Reference
derived

Learn more about this trial

The Hospice Advanced Dementia Symptom Management and Quality of Life Trial

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