The Hospice Advanced Dementia Symptom Management and Quality of Life Trial

NCT ID: NCT03681119

Last Updated: 2020-08-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-11

Study Completion Date

2019-06-12

Brief Summary

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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.

Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Advanced Demential Patients

Group Type EXPERIMENTAL

Dementia symptom management at home hospice edition

Intervention Type BEHAVIORAL

Quality assurance performance improvement program

Hospice IDT Members

Group Type EXPERIMENTAL

Education and Training

Intervention Type BEHAVIORAL

Education and training

Interventions

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Dementia symptom management at home hospice edition

Quality assurance performance improvement program

Intervention Type BEHAVIORAL

Education and Training

Education and training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abraham Brody, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33377138 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32416231 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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18-01265

Identifier Type: -

Identifier Source: org_study_id

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