Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT04121858|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : February 9, 2021
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Dementia||Other: Brain Safe App Other: Attention Control App||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||700 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The primary investigator and outcome assessor will be masked to the App assignment (Brain Safe vs Attention Control Medication list App)|
|Official Title:||Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease|
|Actual Study Start Date :||October 16, 2019|
|Estimated Primary Completion Date :||February 28, 2024|
|Estimated Study Completion Date :||February 28, 2024|
Experimental: Brain Safe App
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.
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.
Sham Comparator: Attention Control App
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.
Other: Attention Control App
The attention control app, called Med Safe, includes only the medication list feature.
- Total standardized daily dose (TSDD) - from medical records [ Time Frame: 12 months ]Total standardized daily dose (TSDD), the cumulative anticholinergic burden computed from medical record medication data over the prior 6 months
- Total standardized daily dose (TSDD) - self-report medication inventory [ Time Frame: 12 months ]Total standardized daily dose (TSDD), the cumulative anticholinergic burden computed from self-reported medication inventory data in the Brain Safe or attention control app
- Choice reaction time (CRT) [ Time Frame: 12 months ]Computer-based assessment of choice reaction time (CRT), used with simple reaction time (SRT) to assess executive function
- Simple Reaction Time (SRT) [ Time Frame: 12 months ]Computer-based test, used with Choice Reaction Time (CRT) test to compute a score, to assess executive function
- Digit-Symbol Substitution Test (DSST) [ Time Frame: 12 months ]Paper-based digit-symbol substitution test, from WAIS-IV ( Wechsler Adult Intelligence Scale-IV) Coding, used to assess processing speed
- Hopkins Verbal Learning Test (HVLT) [ Time Frame: 12 months ]Paper-based list learning and recall test, used to assess memory.
- Trail Making Test (TMT) Parts A and B [ Time Frame: 12 months ]Paper-based test, used to assess executive function
- Health Utilities Index (HUI) Mark 3 [ Time Frame: 12 months ]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
- Medication perceptions [ Time Frame: 12 months ]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)
- Self-reported deprescribing behavior [ Time Frame: 12 months ]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)
- System Usability Scale [ Time Frame: 12 months ]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
- Satisfaction with technology: 3-item standardized survey [ Time Frame: 12 months ]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)
- Technology use [ Time Frame: 12 months ]Usage logs of technology use over time
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121858
|Contact: Christian Vallejo, BSfirstname.lastname@example.org|
|Contact: Kimberly Trowbridgeemail@example.com|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Contact: Jose Azar, MD|
|Richard John Holden||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Richard J Holden, PhD 317-278-5323 firstname.lastname@example.org|
|Principal Investigator:||Richard J Holden, PhD||Indiana University School of Medicine|