Acute Hospital Care at Home for People Living With Dementia

NCT ID: NCT06819852

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2028-05-31

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.

Conditions

Emergency Department Visit; Home Care Services; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Usual care

Acute care at a brick-and-mortar hospital.

Group Type: ACTIVE_COMPARATOR

Standard medical treatment

Intervention Type: OTHER

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

Acute hospital care at home

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

Group Type: EXPERIMENTAL

Acute hospital care at home

Intervention Type: OTHER

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

Interventions

Acute hospital care at home

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

Intervention Type: OTHER

Standard medical treatment

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Levine

Associate Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Central Contacts

David M Levine, MD, MPH, MA

Role: CONTACT

dmlevine@bwh.harvard.edu

617-732-7063

Facility Contacts

David M Levine, MD, MPH, MA

Role: primary

Other Identifiers

R01AG082771-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P000002

Identifier Type: -

Identifier Source: org_study_id