Acute Hospital Care at Home for People Living With Dementia (NCT06819852) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Acute Hospital Care at Home for People Living With Dementia
United States200 participantsStarted 2026-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of days at home
Timeframe: Discharge to 30-days post discharge, up to 30 days