Acute Hospital Care at Home for People Living With Dementia

Not Applicable

Not yet recruiting

• Conditions: Dementia; Emergency Department Visit; Home Care Services

• Registration Number: NCT06819852
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-05
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-10
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of days at home	Discharge to 30-days post discharge, up to 30 days	Sum of the number of days spent at home within the 30-days after an acute care episode

Secondary Outcome Measures

Name	Time	Method
30-day unplanned readmission or mortality	Discharge to 30-days post discharge, up to 30 days	Percentage of unplanned readmissions or mortality
Delirium	Date of admission to date of discharge, estimated 5 days	Percentage of days experiencing delirium while receiving acute care using the short confusion assessment method.
Health-related quality of life	From enrollment for the period of one year	Absolute 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 activity	Date of admission to date of discharge, estimated 5 days	Percent of time sedentary as measured by patch monitoring system.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States