Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04121858
• Other study ID #: 1811254189
• Secondary ID: R01AG056926
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: October 31, 2024

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is an RCT to evaluate the effectiveness of Brain Safe on reducing anticholinergic exposure. Over 42 months, the trial will enroll 700 community-dwelling older adults who were prescribed one or more strong anticholinergics. Participants will be randomized to use the Brain Safe app or an attention control medication list app for 12 months, with monthly usage reminders.

Description:

This study is a randomized clinical trial (RCT) of the efficacy of a direct-to-consumer intervention called Brain Safe to primarily reduce older adults' exposure to prescription anticholinergics and secondarily improve cognitive function and health-related quality of life. Over 42 months, the trial will enroll 700 community-dwelling older adults who were prescribed one or more strong anticholinergics. Participants will be randomized to use the Brain Safe app or an attention control medication list app for 12 months, with monthly usage reminders.

The primary objective is to test the effect of Brain Safe on anticholinergic exposure at 12 months. We hypothesize that anticholinergic exposure will be lower among those randomized to the Brain Safe intervention compared to those randomized to the attention control app at 12 months. Our primary, powered outcome is the total standard daily dose (TSDD) measure of anticholinergic exposure at 12 months, which is calculated over the preceding 6 months of prescription data. We will electronically capture prescription data monthly and compute TSDD at baseline, 6, and 12 months.

The secondary objective is to test the effect of Brain Safe on: (a) cognitive function and (b) health-related quality of life at 12 months. We hypothesize older adults randomized to Brain Safe will have higher (a) cognitive function, measured by using an objective, performance-based composite, and (b) health-related quality of life (HRQOL), compared to those randomized to the attention control app, at 12 months.

Exploratory objectives are to test the effect of Brain Safe on anticholinergic exposure, cognitive function, and HRQOL at 6 months. This aim will explore the presence of early effects of Brain Safe at 6 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 706
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• = 1 primary care visit at Eskenazi Health or IU Health in past 12 months

• Age = 60 years

• Written informed consent and HIPAA authorization for the release of personal health information.

• English-speaking

• At least one prescription for a strong anticholinergic medication with Anticholinergic Cognitive Burden (ACB) score 2 or 3 in prior 12 months, and currently using it

• Community-dwelling in Central Indiana

• Not cognitively impaired

• Not terminally ill

• Not sensory impaired (after correction)

Exclusion Criteria:

• Permanent resident of an extended care facility (nursing home); independent or assisted senior care living is allowed if managing own medications.

• 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

• Involvement in another clinical trial that would prevent or interfere with study objectives

• Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)

• Not currently using anticholinergic medication

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Other:
• Brain Safe App
The Brain Safe app includes the medication list, a personalized risk calculator, multimedia educational content, and a conversation starter/doctor's report.
• Attention Control App
The attention control app, called Med Safe, includes only the medication list feature.

Locations

Country	Name	City	State
United States	IU Health	Indianapolis	Indiana
United States	Richard John Holden	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication perceptions	9-item standardized survey of medication perceptions; developed in-house based on combination of Health Belief Model questionnaires and revised Patients' Attitudes Towards Deprescribing Questionnaire; responses on 5-point agreement scale from strongly agree to strongly disagree, items analyzed separately and as subscale averages (range 1-5, higher indicating more disagreement/less agreement)	12 months
Other	Self-reported deprescribing behavior	4-item standardized survey of self-reported deprescribing behaviors, developed in-house, responses on 5-point agreement scale from strongly agree to strongly disagree, items analyzed separately (range 1-5, higher indicating more disagreement/less agreement)	12 months
Other	System Usability Scale	10-item standardized survey of user-reported technology usability, based on revised System Usability Scale, with scale score computed ranging from 0-100, with 100 indicating highest possible perceived usability	12 months
Other	Satisfaction with technology: 3-item standardized survey	3-item standardized survey of user-reported satisfaction with technology, based on satisfaction items from Technology Acceptance Model questionnaires, responses on 5-point agreement scale from strongly agree to strongly disagree, items analyzed separately and as scale average (range 1-5, higher indicating more disagreement/less agreement)	12 months
Other	Technology use	Usage logs of technology use over time	12 months
Primary	Total standardized daily dose (TSDD) - from medical records	Total standardized daily dose (TSDD), the cumulative anticholinergic burden computed from medical record medication data over the prior 6 months	12 months
Primary	Total standardized daily dose (TSDD) - self-report medication inventory	Total standardized daily dose (TSDD), the cumulative anticholinergic burden computed from self-reported medication inventory data in the Brain Safe or attention control app	12 months
Secondary	Choice reaction time (CRT)	Computer-based assessment of choice reaction time (CRT), used with simple reaction time (SRT) to assess executive function	12 months
Secondary	Simple Reaction Time (SRT)	Computer-based test, used with Choice Reaction Time (CRT) test to compute a score, to assess executive function	12 months
Secondary	Digit-Symbol Substitution Test (DSST)	Paper-based digit-symbol substitution test, from WAIS-IV ( Wechsler Adult Intelligence Scale-IV) Coding, used to assess processing speed	12 months
Secondary	Hopkins Verbal Learning Test (HVLT)	Paper-based list learning and recall test, used to assess memory.	12 months
Secondary	Trail Making Test (TMT) Parts A and B	Paper-based test, used to assess executive function	12 months
Secondary	Health Utilities Index (HUI) Mark 3	Self-reported measure of health-related quality of life, producing a single score on a standardized utility values range from -0.36 for the HUI-3, respectively, to 1.00 with higher scores indicating better outcome	12 months