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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 : October 21, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Richard Holden, Indiana University

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Other: Brain Safe App Other: Attention Control App Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
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)
Primary Purpose: Prevention
Official Title: Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease
Actual Study Start Date : October 11, 2019
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 is a direct-to-consumer intervention with four main features that combine to encourage anticholinergic users to self-initiate de-prescribing of strong prescription anticholinergics, in consultation with a clinician. Intervention components are delivered electronically via mobile app, also accessible as a website via a web browser. In this study, Brain Safe will be loaded on a provided or personal smartphone device. The three features - Medication List, Risk Calculator, Multimedia Content, and Conversation Starter -

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
• Medication List allows users to select their medications from a searchable database, built from RxNorm (National Library of Medicine). Users can also type in a medication. Users can enter for each medication a dosage, frequency, and reason for use. Each medication entry can be saved, edited, or deleted. Individuals can perform a medication review to update in serial order whether each medication is still being taken and at what dose and frequency. The medication review is "due" each month and notifications are sent to users reminding them to complete it.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Hopkins Verbal Learning Test (HVLT) [ Time Frame: 12 months ]
    Paper-based list learning and recall test, used to assess memory.

  5. Trail Making Test (TMT) Parts A and B [ Time Frame: 12 months ]
    Paper-based test, used to assess executive function

  6. 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


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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

  4. 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)

  5. Technology use [ Time Frame: 12 months ]
    Usage logs of technology use over time



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Dana L Musapatika, MS (317) 260-1860 dalmcdon@iu.edu
Contact: Robin Valenzuela, MA (317) 260-1860 Brainsaf@regenstrief.org

Locations
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United States, Indiana
Eskenazi Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Dana L Musapatika, MS    317-260-1860    dalmcdon@iu.edu   
Indiana University Health Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Dana L Musapatika, MS    317-260-1860    dalmcdon@iu.edu   
Sponsors and Collaborators
Indiana University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Richard J Holden, PhD Indiana University School of Medicine

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Responsible Party: Richard Holden, Associate Professor, Indiana University School of Medicine Chief Healthcare Engineer, Center for Health Innovation and Implementation Science, Indiana University
ClinicalTrials.gov Identifier: NCT04121858     History of Changes
Other Study ID Numbers: 1811254189
R01AG056926 ( U.S. NIH Grant/Contract )
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Holden, Indiana University:
anticholinergic
cognitive function
brain
aging
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs