NCT05950607 · Hebrew SeniorLife
Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0
(TRAIN-AD 2)
What this study is about
The goal of this pragmatic cluster randomly assigned clinical trial is to compare management of suspected infection in nursing home residents with dementia The main questions it aims to answer whether residents with dementia in nursing homes randomly assigned to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.
View original scientific description
The goal of this pragmatic cluster randomized clinical trial is to compare management of suspected infection in nursing home residents with dementia The main questions it aims to answer whether residents with dementia in nursing homes randomized to use a multicomponent intervention to optimize suspected infection management ( versus usual care) use less antibiotics and fewer burdensome interventions.
Interventions
BEHAVIORAL
TRAIN AD 2.0
The study intervention is a multi-component training program targeting direct care providers and healthcare proxies for NH residents with moderate to advanced dementia intended to improve the management of urinary tract infections (UTIs) and lower respiratory tract infections (LRIs). The components include: A. Provider Orientation: At NH start-up and q2 months providers will be offered orientations sessions involving two 15-minute presentations, one focused on the background and rationale for the program and one focused on describing the program components. B. A case-based on-line course, "Infection Management in Moderate to Advanced Dementia," C. Posters and pocket cards for providers displaying algorithms guiding appropriate antimicrobial initiation for suspected UTIs and LRIs that integrate patient preferences, and D. Proxies of ALL residents in the facility will be sent a booklet related to infection management for persons with moderate to advanced dementia. .
Primary outcome measures
Antimicrobial use in residents with moderate to advanced dementia
Time frame: 12 months
Number of antimicrobial courses/person-year among residents with moderate to advanced dementia.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- A diagnosis of dementia (any type)
- Cognitive Functional Scale (CFS) \> 1
- NH length of stay \>90 days The CFS score categorizes cognitive impairment status based on data in the electronic health record into: 1. None, 2. Mild, 3. Moderate, and 4. Severe (advanced). For the primary outcome, the analysis will be restricted to residents with a CFS score of 3 or 4.
Exclusion criteria
- Less than 60 years of age
- Living in nursing home for less than 90 days
- Does not have diagnosis of dementia
- Does not meet CFS \>1 score
Where
- Boston, Massachusetts
Collaborators
Brown University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 6, 2026 · Source of record for eligibility and locations