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Acute Hospital Care at Home for People Living With Dementia

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06819852
Enrollment
200
Registered
2025-02-11
Start date
2026-08-17
Completion date
2029-04-01
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Emergency Department Visit, Home Care Services

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.

Interventions

OTHERAcute hospital care at home

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

OTHERStandard medical treatment

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

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Data collectors

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* Hospitalized in the last 30 days * 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

Design outcomes

Primary

MeasureTime frameDescription
Number of days at homeDischarge to 30-days post discharge, up to 30 daysSum of the number of days spent at home within the 30-days after an acute care episode

Secondary

MeasureTime frameDescription
30-day unplanned readmission or mortalityDischarge to 30-days post discharge, up to 30 daysPercentage of unplanned readmissions or mortality
DeliriumDate of admission to date of discharge, estimated 5 daysPercentage of days experiencing delirium while receiving acute care using the short confusion assessment method.
Health-related quality of lifeFrom enrollment for the period of one yearAbsolute change of health-related quality of life over the year through the dementia quality of life survey (DEMQOL), or for patients unable to complete the survey, its proxy version (DEMQOL-Proxy).
Physical activityDate of admission to date of discharge, estimated 5 daysPercent of time sedentary as measured by patch monitoring system.

Countries

United States

Contacts

CONTACTDavid M Levine, MD, MPH, MA
dmlevine@bwh.harvard.edu617-732-7063
CONTACTFernando Chavarria, MD, MSc
fchavarria@bwh.harvard.edu857-307-2673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026