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Behavioural Intervention

Brain Safe App for Alzheimer's Disease

N/A

Waitlist Available

Led By Richard J Holden, PhD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

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

Must have

Age ≥ 60 years

Not cognitively impaired

Must not have

Diagnosis of Alzheimer's disease or related dementia (ADRD), determined by International Classification of Diseases (ICD)-9/ICD-10 codes or current use of a medication for ADRD

Diagnosis of schizophrenia, bipolar disorder, or schizoaffective disorder defined by ICD-9/ICD-10 codes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial will test whether the Brain Safe app can reduce exposure to anticholinergic medications in older adults.

Who is the study for?

This trial is for adults over 60 in Central Indiana who are English-speaking, have had a primary care visit within the last year, and are currently prescribed strong anticholinergic medications. They must not be cognitively impaired, terminally ill, or living in extended care facilities. Those with Alzheimer's disease or severe mental health conditions like schizophrenia cannot participate.

What is being tested?

The study tests if the Brain Safe app can reduce exposure to drugs linked to Alzheimer's when used by older adults taking anticholinergics. Participants will either use this app or a control medication list app for one year with monthly reminders.

What are the potential side effects?

Since this trial involves using an application rather than a drug intervention, direct side effects from usage are minimal but may include discomfort due to prolonged screen time or stress from technology use.

Eligibility Criteria

Inclusion Criteria

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

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I am 60 years old or older.

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I do not have any cognitive impairments.

Exclusion Criteria

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

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I have been diagnosed with Alzheimer's or a similar type of dementia.

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I have been diagnosed with schizophrenia, bipolar disorder, or schizoaffective disorder.

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I am not taking any anticholinergic medications.

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

Total standardized daily dose (TSDD) - from medical records

Total standardized daily dose (TSDD) - self-report medication inventory

Secondary study objectives

Choice reaction time (CRT)

Digit-Symbol Substitution Test (DSST)

Health Utilities Index (HUI) Mark 3

+3 more

Other study objectives

Medication perceptions

Satisfaction with technology: 3-item standardized survey

Self-reported deprescribing behavior

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Brain Safe AppExperimental Treatment1 Intervention

1)Brain Safe App provides conversation starters for older adult patients on target anticholinergics. The conversation starters assist the patient to have discussions with their physicians regarding reduction in exposure to prescription anticholinergics. 2) Provides anticholinergic risk assessment.

Group II: Attention Control AppPlacebo Group1 Intervention

1) Attention Control App provides a medication list for older patients to use but lacks the conversation starters for patient to use with there physicians aimed at reduction in exposure to prescription anticholinergics.2) No anticholinergic risk assessment.

0 / 5Eligibility criteria met