DementiaTRAIN-AD 2NCT05950607
Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0
A study testing TRAIN AD 2.0 in people with Dementia and Alzheimer Disease, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 106 years
- Conditions the study is for
- Dementia, Alzheimer Disease, Infections
- What is being tested?
- TRAIN AD 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 106 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 60
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hebrew SeniorLife
Boston, Massachusetts, 02131
Susan Mitchell, 617-281-3669, smitchell@hsl.harvard.edu
About this study
Official title: Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0 (TRAIN-AD 2.0)
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.
Read the detailed description
This 52-month study (8 months preparation; 34 months trial conduct; 10 months data analyses and manuscript preparation)is a parallel cluster ePCT of an intervention to improve infection management for suspected infections among residents with moderate to advanced dementia (N=600; N=300/arm) living in NHs (N=50; N=25/arm). Facilities are members of a provider managed care network, Iowa Health Care Quality Network ('Network'). The intervention will be similar to the original TRAIN-AD program, but adapted for moderate to advanced dementia and rolled out in the Network. At each intervention NH, the intervention will be implemented for 24-months. Control NHs will employ usual care. In all NHs, there will be a 2-month startup period, 12-month resident enrollment period, and 24-months data collection period (Figure 2). Eligible residents with dementia will be identified using the EHR and Minimum DataSet (MDS) and followed up to 12 months. Outcome data will be ascertained from the EHR. Randomization and program roll out will be at the facility level. Analyses at the resident level. Clinical outcomes compared between arms at 12 months will be: 1. Antimicrobial courses/person-year in residents with moderate to advanced dementia (primary outcome) and all residents with dementia (secondary outcome) (Aim 1); and 2. Number of burdensome procedures/person-year used to manage suspected infections among residents with moderate to advanced dementia and those at all stages of dementia including: hospital transfers, urine specimens, chest x-rays, and blood cultures (secondary outcomes) (Aim 2). A process evaluation of implementation will be conducted in the intervention arm based on the RE-AIM framework1 (Aim 3) using quantitative and qualitative data (stakeholder interviews).
- Conditions
- Dementia, Alzheimer Disease, Infections
- Being tested
- TRAIN AD 2.0
- Medical subject headings
- Dementia, Alzheimer Disease, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAIN AD 2.0Behavioural
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. .
| Study group | Role | What they receive |
|---|---|---|
| TRAIN AD 2.0 | Experimental | Nursing homes randomized to the experimental arm will emply a multicomponent intervention among their providers designed to improve the management of suspected infections in residents with dementia. The components include: a.Orientation sessions for providers, b.On-line case based course for providers, c.Infection management algorithms for providers, d. Guidelines for providers to communicate with proxies, and e. Education booklet about infections in dementia for providers. Receives: Behavioral: TRAIN AD 2.0 |
| Usual Care | Active comparator | Nursing homes randomized to the conrol arm will employ usual care to manage nursing home residents with dementia with suspected infections. Receives: Behavioral: TRAIN AD 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antimicrobial use in residents with moderate to advanced dementia
Number of antimicrobial courses/person-year among residents with moderate to advanced dementia.
Measured: 12 months
Secondary outcomes (3)
Antimicrobial use in residents with dementia
Number of antimicrobial courses/person-year among residents with dementia at any stage.
Measured: 12 months
Burdensome interventions in residents with moderate to advanced dementia
Number of burdensome interventions (hospital transfers, bladder catheterization, chest x-ray, blood cultures) used to evaluate suspected infections/person-year among residents withmoderate to advanced dementia.
Measured: 12 months
Burdensome interventions in residents with dementia
Number of burdensome interventions (hospital transfers, bladder catheterization, chest x-ray, blood cultures) used to evaluate suspected infections/person-year among residents with dementia.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start13 Nov 2023
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Sponsor
- Investigators
- Susan Mitchell, MD, MPH, Principal investigator, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950607
- Sponsor's protocol ID
- NIA R37AG032982
- Acronym
- TRAIN-AD 2
- Status last verified
- Jan 2026
- First submitted
- 10 Jul 2023
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0 (TRAIN-AD 2.0)
- ClinicalTrials.gov ID
- NCT05950607
- Acronym / sponsor ID
- TRAIN-AD 2 / NIA R37AG032982
- Conditions
- Dementia, Alzheimer Disease, Infections
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This 52-month study (8 months preparation; 34 months trial conduct; 10 months data analyses and manuscript preparation)is a parallel cluster ePCT of an intervention to improve infection management for suspected infections among residents with moderate to advanced dementia (N=600; N=300/arm) living in NHs (N=50; N=25/arm). Facilities are members of a provider managed care network, Iowa Health Care Quality Network ('Network'). The intervention will be similar to the original TRAIN-AD program, but adapted for moderate to advanced dementia and rolled out in the Network. At each intervention NH, the intervention will be implemented for 24-months. Control NHs will employ usual care. In all NHs, there will be a 2-month startup period, 12-month resident enrollment period, and 24-months data collection period (Figure 2). Eligible residents with dementia will be identified using the EHR and Minimum DataSet (MDS) and followed up to 12 months. Outcome data will be ascertained from the EHR. Randomization and program roll out will be at the facility level. Analyses at the resident level. Clinical outcomes compared between arms at 12 months will be: 1. Antimicrobial courses/person-year in residents with moderate to advanced dementia (primary outcome) and all residents with dementia (secondary outcome) (Aim 1); and 2. Number of burdensome procedures/person-year used to manage suspected infections among residents with moderate to advanced dementia and those at all stages of dementia including: hospital transfers, urine specimens, chest x-rays, and blood cultures (secondary outcomes) (Aim 2). A process evaluation of implementation will be conducted in the intervention arm based on the RE-AIM framework1 (Aim 3) using quantitative and qualitative data (stakeholder interviews).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRAIN AD 2.0 | Experimental | Behavioral: TRAIN AD 2.0Nursing homes randomized to the experimental arm will emply a multicomponent intervention among their providers designed to improve the management of suspected infections in residents with dementia. The components include: a.Orientation sessions for providers, b.On-line case based course for providers, c.Infection management algorithms for providers, d. Guidelines for providers to communicate with proxies, and e. Education booklet about infections in dementia for providers. |
| Usual Care | Active comparator | Behavioral: TRAIN AD 2.0Nursing homes randomized to the conrol arm will employ usual care to manage nursing home residents with dementia with suspected infections. |
Who may qualify
- Ages
- 60 to 106 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 60
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRAIN AD 2.0The 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. . | Behavioural | TRAIN AD 2.0, Usual Care |
Primary outcome
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.
3 secondary outcomes
Antimicrobial use in residents with dementia
Time frame: 12 months
Burdensome interventions in residents with moderate to advanced dementia
Time frame: 12 months
Burdensome interventions in residents with dementia
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan Mitchell, MD, MPH principal investigator
Hebrew SeniorLife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAIN AD 2.0 in people with Dementia and Alzheimer Disease, run by Hebrew SeniorLife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Susan Mitchell, MD, MPH (16172813669, smitchell@hsl.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antimicrobial use in residents with moderate to advanced dementia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.