NCT03681119

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 23, 2020

Completed
Last Updated

August 13, 2020

Status Verified

August 1, 2020

Enrollment Period

4 months

First QC Date

September 20, 2018

Results QC Date

July 7, 2020

Last Update Submit

August 11, 2020

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

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

    Percentage of Hospice IDT Members who Complete Required Education and Training

    2 Months

Study Arms (2)

Advanced Demential Patients

EXPERIMENTAL
Behavioral: Dementia symptom management at home hospice edition

Hospice IDT Members

EXPERIMENTAL
Behavioral: Education and Training

Interventions

Dementia symptom management at home hospice editionBEHAVIORAL

Quality assurance performance improvement program

Advanced Demential Patients
Education and TrainingBEHAVIORAL

Education and training

Hospice IDT Members

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Persons with Dementia:
  • None
  • Clinicians:
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (2)

  • 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.

    PMID: 33377138DERIVED

  • 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.

    PMID: 32416231DERIVED

MeSH Terms

Conditions

Dementia

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Abraham Brody, PhD, RN, FAAN
Organization
NYU Langone Health
Abraham.Brody@nyulangone.org
212-992-7341

Study Officials

  • Abraham Brody, PhD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 21, 2018

Study Start

February 11, 2019

Primary Completion

June 12, 2019

Study Completion

June 12, 2019

Last Updated

August 13, 2020

Results First Posted

July 23, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL
Time Frame
Beginning 3 months and ending 5 years following article publication.
Access Criteria
Researchers who provide a methodologically sound proposal.

Locations

US(1)