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Not yet recruiting NCT06819852

Acute Hospital Care at Home for People Living With Dementia

No phase Interventional Emergency Department Visit Home Care Services Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acute hospital care at home, Standard medical treatment.
Who it may be relevant to
Registry conditions: Emergency Department Visit, Home Care Services, Dementia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Skipping the Hospital: Acute Hospital Care at Home for People Living With Dementia

Overview

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.

Interventions

  • Other Acute hospital care at home
    Home visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed.
  • Other Standard medical treatment
    Standard acute and emergency care delivered in a brick-and-mortar hospital setting.

Primary outcome measures

  • Number of days at home [Time frame: Discharge to 30-days post discharge, up to 30 days]
Secondary outcome measures (4)
  • 30-day unplanned readmission or mortality [Time frame: Discharge to 30-days post discharge, up to 30 days]
  • Delirium [Time frame: Date of admission to date of discharge, estimated 5 days]
  • Health-related quality of life [Time frame: From enrollment for the period of one year]
  • Physical activity [Time frame: Date of admission to date of discharge, estimated 5 days]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Brigham and Women's Hospital — Boston

Identifiers

NCT: NCT06819852 · 2025P000002 · R01AG082771-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗