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Behavioral Intervention

TRAIN AD 2.0 for Alzheimer's Disease (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

TRAIN-AD 2 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.Check my eligibility

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.See study design

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.

TRAIN-AD 2 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with a form of dementia.

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I am older than 60 years.

TRAIN-AD 2 Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Antimicrobial use in residents with moderate to advanced dementia

Secondary outcome measures

Antimicrobial use in residents with dementia

Burdensome interventions in residents with dementia

Burdensome interventions in residents with moderate to advanced dementia

TRAIN-AD 2 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hebrew SeniorLifeLead Sponsor

45 Previous Clinical Trials

269,799 Total Patients Enrolled

Brown UniversityOTHER

456 Previous Clinical Trials

557,604 Total Patients Enrolled

Susan Mitchell, MD, MPHPrincipal InvestigatorHebrew SeniorLife

1 Previous Clinical Trials

197,692 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants involved in this clinical study?

"Affirmative. Information available on clinicaltrials.gov indicates that this specific research endeavor is actively seeking individuals to participate. Initially shared on November 13, 2023, and subsequently revised by February 27, 2024, the trial aims to enroll a total of 750 patients from one designated site."

Answered by AI

Does this clinical trial include individuals who are above the age of 65?

"Individuals aged between 60 and 106 years old are eligible for inclusion in this trial. There is a substantial number of studies available for participants under 18 years (217) as well as those above 65 years (1314)."

Answered by AI

Are there ongoing efforts to enlist individuals for participation in this current research study?

"Indeed, as per details on clinicaltrials.gov, this particular research study is currently in the recruitment phase. The initial posting of the trial occurred on November 13th, 2023, and its latest update was recorded on February 27th, 2024. Approximately 750 participants are sought from a single designated site."

Answered by AI

What is the level of risk associated with TRAIN AD 2.0 for individuals participating in the trial?

"Our team at Power has rated the safety of TRAIN AD 2.0 as a 3 on our scale, given that this is classified as a Phase 4 trial denoting an approved therapy."

Answered by AI

What are the specific criteria for individuals to qualify and participate in this trial?

"The research study is open to enrollment for 750 individuals with Alzheimer's disease aged between 60 and 106 years. Specifically, eligible participants must satisfy the subsequent conditions: Cognitive Functional Scale (CFS) > 1, Age exceeding 60, A confirmed dementia diagnosis of any subtype, a prolonged nursing home stay surpassing 90 days. The CFS evaluates cognitive function status based on electronic health record data as follows: No impairment (level 1), Mild impairment (level 2), Moderate impairment (level 3), or Severe advanced impairment (level 4). Evaluation of primary outcomes will concentrate solely on residents with a C"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0

2023. "Trial to Reduce Antimicrobial Use in Nursing Home Residents With Alzheimer's Disease and Other Dementias 2.0". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05950607.

All > Alzheimers Disease Boston > Infectious Disease