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Behavioral Intervention

Reducing Antibiotic Use for Dementia (TRAIN-AD 2 Trial)

Phase 4

Recruiting

Led By Susan Mitchell, MD, MPH

Research Sponsored by Hebrew SeniorLife

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A diagnosis of dementia (any type)

Age > 60

Must not have

Less than 60 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to compare different ways of managing suspected infections in nursing home residents with dementia. It wants to see if using a specific intervention can help reduce the use of antibiotics and other burdensome treatments compared

Who is the study for?

This trial is for nursing home residents over 60 years old with a diagnosis of any type of dementia, who have lived in the facility for more than 90 days. They must have moderate to severe cognitive impairment. It's not suitable for those without or with only mild cognitive issues.

What is being tested?

The study tests TRAIN AD 2.0, an intervention designed to optimize infection management among dementia patients, aiming to reduce antibiotic use and avoid unnecessary treatments compared to standard care practices.

What are the potential side effects?

Since this trial focuses on reducing interventions rather than administering drugs, side effects are not the main concern; however, there may be risks associated with changing usual care practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a form of dementia.

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I am older than 60 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am younger than 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Antimicrobial use in residents with moderate to advanced dementia

Secondary study objectives

Antimicrobial use in residents with dementia

Burdensome interventions in residents with dementia

Burdensome interventions in residents with moderate to advanced dementia

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TRAIN AD 2.0Experimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 Intervention

Nursing homes randomized to the conrol arm will employ usual care to manage nursing home residents with dementia with suspected infections.

0 / 3Eligibility criteria met