Acute Hospital Care at Home for People Living With Dementia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Acute hospital care at home
Other interventionHome visit for a serious illness conversation. Acute illness evaluation on demand. Acute hospital care at home as needed.
Standard medical treatment
Other interventionStandard acute and emergency care delivered in a brick-and-mortar hospital setting.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Usual careActive comparator 1 intervention
Group B: Acute hospital care at homeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of days at home
Sum of the number of days spent at home within the 30-days after an acute care episode
Time frame
Discharge to 30-days post discharge, up to 30 daysSecondary outcomes
1
30-day unplanned readmission or mortality
Percentage of unplanned readmissions or mortality
Time frame
Discharge to 30-days post discharge, up to 30 days2
Delirium
Percentage of days experiencing delirium while receiving acute care using the short confusion assessment method.
Time frame
Date of admission to date of discharge, estimated 5 days3
Health-related quality of life
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).
Time frame
From enrollment for the period of one year4
Physical activity
Percent of time sedentary as measured by patch monitoring system.
Time frame
Date of admission to date of discharge, estimated 5 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: