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Behavioural Intervention
Brain Safe App for Alzheimer's Disease
Phase 2 & 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 60 years old or older.
Select...
I do not have any cognitive impairments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total standardized daily dose (TSDD) - from medical records
Total standardized daily dose (TSDD) - self-report medication inventory
Secondary outcome measures
Choice reaction time (CRT)
Digit-Symbol Substitution Test (DSST)
Health Utilities Index (HUI) Mark 3
+3 moreOther outcome measures
Medication perceptions
Satisfaction with technology: 3-item standardized survey
Self-reported deprescribing behavior
+2 moreTrial 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.
Find a Location
Who is running the clinical trial?
Indiana UniversityLead Sponsor
980 Previous Clinical Trials
982,282 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,363 Total Patients Enrolled
Richard J Holden, PhDPrincipal InvestigatorIndiana University School of Medicine
2 Previous Clinical Trials
200 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have impaired senses, even with correction like glasses or hearing aids.I have been diagnosed with Alzheimer's or a similar type of dementia.I am 60 years old or older.I am currently using a strong anticholinergic medication prescribed in the last year.I have been diagnosed with schizophrenia, bipolar disorder, or schizoaffective disorder.You have a condition that makes it difficult for you to use a mobile touchscreen device or participate in the study activities, even with help.I am not taking any anticholinergic medications.You live in Central Indiana.I have visited a primary care doctor at Eskenazi Health or IU Health in the last year.I live in a nursing home or I manage my own medications in senior care.I do not have any cognitive impairments.
Research Study Groups:
This trial has the following groups:- Group 1: Attention Control App
- Group 2: Brain Safe App
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How can volunteers sign up for this experiment?
"That is correct, the online clinicaltrials.gov registry currently lists this study as recruiting. This clinical trial was originally posted on October 16th, 2019 and has since been updated on July 21st, 2022. The study is looking for 700 individuals across 2 locations."
Answered by AI
How many people are signing up for this clinical trial?
"Yes, this is an active study that was posted on October 16th, 2019 and is recruiting for 700 participants at 2 sites."
Answered by AI
Who else is applying?
What state do they live in?
Indiana
Arizona
Other
New York
How old are they?
18 - 65
What site did they apply to?
IU Health
What portion of applicants met pre-screening criteria?
Met criteria
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