NCT05749146

Brief Summary

A multi-site, single-blinded, parallel, randomized-controlled trial to evaluate the effectiveness of a novel model of in-home palliative care for dementia patients and their family caregivers. From inpatient and outpatient settings associated with four hospitals across New York City, patients with advanced dementia and their family caregivers will be randomized to intervention or augmented control.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jun 2023Mar 2027

First Submitted

Initial submission to the registry

February 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 8, 2023

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

3.8 years

First QC Date

February 18, 2023

Last Update Submit

March 16, 2026

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

  • Symptom Management as measured by the End of Life for Dementia scale

    This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator. The Symptom Management at the End of Life in Dementia (SM-EOLD) scale responses range from 0 to 45 with higher scores indicating better symptom management.

    6 months

Secondary Outcomes (10)

  • Number of Hospital Admissions

    at 12 months

  • Number of Hospital Stays

    at 12 months

  • Patient reported treatment concordance

    at 12 months

  • Cost Analysis

    at 12 months

  • Caregiver burden per Zarit Burden Inventory

    at 6 months

  • +5 more secondary outcomes

Study Arms (2)

Palliative care at home

EXPERIMENTAL

Randomized to intervention arm

Behavioral: Home Palliative Care

Augmented control

ACTIVE COMPARATOR

Randomized to augmented control (visits to the caregiver from a CHW without training in dementia or palliative care)

Behavioral: Home Palliative Care

Interventions

Home Palliative CareBEHAVIORAL

Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.

Augmented controlPalliative care at home

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • have advanced dementia, based on Global Deterioration Score (GDS)\>6
  • impairment in at least one activity of daily living (ADL -which is inherent in this level of GDS)
  • at least one hospitalization or ED visit within the last 12 months
  • a physician who is primarily responsible for their dementia-related care whose clinical outpatient site is associated with one of the four Mount Sinai sites in Manhattan
  • a family caregiver willing to enroll
  • a residence in Manhattan where they are currently living (not in a long-term care facility)
  • capacity to consent or a legal representative available to provide consent
  • fluency in English or Spanish, or their legal representative must be fluent in English or Spanish
  • age \>64.

You may not qualify if:

  • Does not have a family caregiver to enroll
  • Does not reside in Manhattan outside of long-term care facility
  • Does not have fluency in English or Spanish Doesn't

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ichan School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Laura P Gelfman, MD, MPH

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Single blind control
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Subjects assigned to intervention or control arms in a 1:1 ratio
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 1, 2023

Study Start

June 8, 2023

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

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 9 months and ending 36 months following article publication.
Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose. For individual participant data meta-analysis. Proposals should be directed to christian.espino@mssm.edu. To gain access, data requestors will need to sign a data access agreement.

Locations

US(1)