NCT06819852

Brief Summary

The investigators will perform a parallel-group multicenter randomized controlled trial of a 1-year pre-enrolled acute hospital care at home intervention vs usual care for people living with dementia. Patients will be randomized only after eligibility determination and after the family caregiver agrees to enroll; people living with dementia will assent when able. Patients will be allocated in a concealed fashion to the control and intervention groups in randomly selected block sizes of 4 or 6 in 4 strata reflecting their functional status (activities of daily living: 0, 1, 2-3, 4-6). Although family and clinicians cannot be blinded, the investigators will blind the data collectors and assessors.

Trial Health

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Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress5%
Apr 2026May 2028

First Submitted

Initial submission to the registry

February 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

2.1 years

First QC Date

February 5, 2025

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of days at home

    Sum of the number of days spent at home within the 30-days after an acute care episode

    Discharge to 30-days post discharge, up to 30 days

Secondary Outcomes (4)

  • 30-day unplanned readmission or mortality

    Discharge to 30-days post discharge, up to 30 days

  • Delirium

    Date of admission to date of discharge, estimated 5 days

  • Health-related quality of life

    From enrollment for the period of one year

  • Physical activity

    Date of admission to date of discharge, estimated 5 days

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Acute care at a brick-and-mortar hospital.

Other: Standard medical treatment

Acute hospital care at home

EXPERIMENTAL

Home visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed.

Other: Acute hospital care at home

Interventions

Home visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed.

Acute hospital care at home

Standard acute and emergency care delivered in a brick-and-mortar hospital setting.

Usual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of moderate or severe dementia (as ascertained by the Quick Dementia Rating System; QDRS)
  • Resides in a private or assisted living residence with or nearby (\<15min travel time) to a family caregiver
  • Resides within the Mass General Brigham (MGB) home hospital catchment area
  • Has had at least 1 hospitalization in the last 12 months.

You may not qualify if:

  • No functioning utilities, such as no working heat (October-April), no running water, or no electricity.
  • Resides in skilled nursing facility
  • Resides in group home
  • Domestic violence screen positive
  • In police custody
  • Family caregiver unable to initiate or maintain communication with care team
  • End-stage renal disease on hemodialysis
  • On methadone requiring daily pickup of medication
  • Active substance use disorder, without functioning treatment plan
  • Psychiatric diagnosis that would prohibit successful home hospital care
  • Acute delirium without explanation or without the ability to manage at home
  • Patients with cancer requiring consistent hospital-based treatments
  • Cannot ambulate to bedside commode with assistance present in the home (if different from baseline), unless home-based aides are available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

David M Levine, MD, MPH, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Data collectors
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician

Study Record Dates

First Submitted

February 5, 2025

First Posted

February 11, 2025

Study Start

April 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations