- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04121858
Brain Safe: Forbrugerintervention for at reducere eksponeringen for lægemidler forbundet med Alzheimers sygdom
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Denne undersøgelse er et randomiseret klinisk forsøg (RCT) af effektiviteten af en direkte-til-forbruger-intervention kaldet Brain Safe for primært at reducere ældre voksnes eksponering for receptpligtige antikolinergika og sekundært forbedre kognitiv funktion og sundhedsrelateret livskvalitet. I løbet af 42 måneder vil forsøget indskrive 700 ældre voksne i lokalsamfundet, som fik ordineret et eller flere stærke antikolinergika. Deltagerne vil blive randomiseret til at bruge Brain Safe-appen eller en app for opmærksomhedskontrol med medicinliste i 12 måneder med månedlige påmindelser om brug.
Det primære formål er at teste effekten af Brain Safe på antikolinerg eksponering efter 12 måneder. Vi antager, at antikolinerg eksponering vil være lavere blandt dem, der er randomiseret til Brain Safe-interventionen, sammenlignet med dem, der er randomiseret til opmærksomhedskontrol-appen efter 12 måneder. Vores primære, drevne resultat er den samlede standard daglige dosis (TSDD) mål for antikolinerg eksponering ved 12 måneder, som er beregnet over de foregående 6 måneders receptdata. Vi vil elektronisk indsamle receptdata hver måned og beregne TSDD ved baseline, 6 og 12 måneder.
Det sekundære mål er at teste effekten af Brain Safe på: (a) kognitiv funktion og (b) sundhedsrelateret livskvalitet efter 12 måneder. Vi antager, at ældre voksne randomiseret til Brain Safe vil have højere (a) kognitiv funktion, målt ved at bruge en objektiv, præstationsbaseret sammensætning og (b) sundhedsrelateret livskvalitet (HRQOL), sammenlignet med dem, der er randomiseret til opmærksomhedskontrollen app, på 12 måneder.
Udforskende mål er at teste effekten af Brain Safe på antikolinerg eksponering, kognitiv funktion og HRQOL efter 6 måneder. Dette mål vil undersøge tilstedeværelsen af tidlige virkninger af Brain Safe efter 6 måneder.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University
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Indianapolis, Indiana, Forenede Stater, 46202
- IU Health
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- ≥ 1 primærplejebesøg hos Eskenazi Health eller IU Health inden for de seneste 12 måneder
- Alder ≥ 60 år
- Skriftligt informeret samtykke og HIPAA-godkendelse til frigivelse af personlige helbredsoplysninger.
- Engelsktalende
- Mindst én recept på en stærk antikolinerg medicin med anticholinergisk kognitiv byrde (ACB) score 2 eller 3 inden for de foregående 12 måneder, og bruger det i øjeblikket
- Samfundsbolig i det centrale Indiana
- Ikke kognitivt svækket
- Ikke uhelbredeligt syg
- Ikke sensorisk svækket (efter korrektion)
Ekskluderingskriterier:
- Fastboende på en udvidet plejefacilitet (plejehjem); uafhængig eller assisteret ældrepleje er tilladt, hvis du administrerer egen medicin.
- Diagnose af Alzheimers sygdom eller relateret demens (ADRD), bestemt af International Classification of Diseases (ICD)-9/ICD-10 koder eller aktuel brug af en medicin mod ADRD
- Diagnose af skizofreni, bipolar lidelse eller skizoaffektiv lidelse defineret af ICD-9/ICD-10 koder
- Inddragelse i et andet klinisk forsøg, der ville forhindre eller forstyrre undersøgelsens mål
- Sensorisk eller anden svækkelse, der forbyder brugen af en mobil berøringsskærm eller anden studieaktivitet (efter korrektion)
- Bruger ikke antikolinerg medicin i øjeblikket
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Brain Safe App
1) Brain Safe App giver samtalestartere til ældre voksne patienter på target antikolinergika.
Samtalestarterne hjælper patienten med at have drøftelser med deres læger om reduktion af eksponeringen for receptpligtige antikolinergika.
2) Giver antikolinerg risikovurdering.
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Brain Safe-appen inkluderer medicinlisten, en personlig risikoberegner, multimedieundervisningsindhold og en samtalestarter/lægerapport.
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Sham-komparator: Opmærksomhedskontrol app
1) Attention Control App giver en medicinliste, som ældre patienter kan bruge, men mangler samtalestarterne, som patienten kan bruge med deres læger med det formål at reducere eksponeringen for receptpligtige antikolinergika.2)
Ingen antikolinerg risikovurdering.
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Opmærksomhedskontrol-appen, kaldet Med Safe, inkluderer kun medicinlistefunktionen.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Total Standardized Daily Dose (TSDD) - From Medical Records
Tidsramme: Baseline, 6 months, 12 Months
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To calculate the Total Standardized Daily Dose (TSDD), we first calculated the Standardized Daily Dose (SDD) for each anticholinergic medication with an ACB Score of 2 or 3. SDD was calculated by multiplying the strength by the units per dose and frequency per day and number of refills. The product was divided by the minimum effective daily dose (where available) or the minimum effective geriatric dose to standardize the quantity across multiple classes of medications. The SDD for all anticholinergics with an ACB score 2 or 3 was then summed for each participant for each 6-month period, and divided by the number of days in the relevant six month period to arrive at a TSDD. Range: The minimum possible value is 0 (optimal outcome; indicating zero exposure to ACB 2 or 3 medications). There is no fixed theoretical maximum score(higher value more exposure), as the upper limit is mathematically determined by the total volume and combination of medications a participant is prescribed. |
Baseline, 6 months, 12 Months
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Log Transformed Total Standardized Daily Dose (TSDD) - From Medical Records
Tidsramme: Baseline, 6, and 12 Months
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Construct: Measures natural log-transformed average daily exposure to medications with an Anticholinergic Cognitive Burden (ACB) score of 2 or 3 to normalize data distribution.How Computed: Medication Standardized Daily Dose (SDD) = (strength × units/dose × frequency/day × refills) / minimum effective daily or geriatric dose.
The SDD for all eligible drugs is summed over 6 months, divided by the number of days in that period to find raw TSDD, and natural log-transformed ($\ln(x+1)$ or similar) for the final score.Scale Range: Minimum value is 0 (representing 0 raw TSDD, or zero exposure).
There is no fixed theoretical maximum, as it is mathematically determined by the volume of medications prescribed.Interpretation: A value of 0 is the optimal outcome (no exposure).
Higher values represent greater exposure (worse outcome).
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Baseline, 6, and 12 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Overall Cognitive Score
Tidsramme: Baseline, 6 months, and 12 months
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An overall cognitive score evaluating three domains: memory/new learning, executive function, and processing speed. Calculated by taking the mean of standardized Z-scores from the following specific tests: Hopkins Verbal Learning Test-Revised (HVLT-R) total and delayed recall; Trail Making Test Parts A and B; Phonetic Fluency; Semantic Fluency (adjusted); and Symbol Digit Modalities Test (correct). A Z-score of 0 represents the baseline study population mean. Standardized scores theoretically range from -3.0 to +3.0. Higher positive Z-scores (standard deviations above the mean) represent better cognitive performance (better outcome). Lower negative Z-scores represent worse cognitive performance (worse outcome). No clinical threshold is defined. Z-scores were derived using baseline means, with timed tests (e.g., Trails) inverted prior to averaging so higher always means better performance. |
Baseline, 6 months, and 12 months
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Choice Reaction Time (CRT)
Tidsramme: Baseline
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Computer-based assessment of Choice Reaction Time (CRT). It is used to evaluate executive function, attention, and psychomotor speed by measuring the time elapsed between the presentation of one of multiple possible stimuli and the participant's correct response. The final score represents the average response time (in milliseconds/seconds) across all valid test trials. The minimum value is 0. There is no fixed theoretical maximum, as the upper limit is bounded only by the participant's maximum delay. Lower values represent faster reaction times, indicating better executive functioning and psychomotor speed (a better outcome). Higher values indicate slower reaction times (a worse outcome). |
Baseline
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Health Utilities Index (HUI) Mark 3
Tidsramme: Baseline, 6 months, and 12 months
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The Health Utilities Index Mark 3 (HUI3) is a self-reported, multi-attribute health status classification system used to measure overall health-related quality of life and functional capacity. The score is calculated using responses across eight dimensions of health (vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain). These subscales are combined using a mathematically weighted scoring algorithm to compute a single total utility index score. The total utility score ranges from a minimum of -0.36 (representing a health state considered worse than death) to a maximum of 1.00 (representing perfect health). A score of 0.00 represents death. Higher values represent a better health-related quality of life (a better outcome). Lower values represent worse health status (a worse outcome). |
Baseline, 6 months, and 12 months
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Hopkins Verbal Learning Test (HVLT) Total Recall
Tidsramme: Baseline, 6 months, and 12 months
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Hopkins Verbal Learning Test (HVLT) Total Recall. It is a paper-based list learning and recall assessment used to evaluate verbal memory and new learning capacity. Participants are read a list of 12 words and asked to freely recall as many as possible across three consecutive learning trials. The total recall score is calculated by summing the number of correctly recalled words across all three trials. The total recall score ranges from a minimum of 0 to a maximum of 36. Higher values represent a greater number of words correctly recalled, indicating better memory and verbal learning function (a better outcome). Lower scores indicate worse memory function (a worse outcome). |
Baseline, 6 months, and 12 months
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Hopkins Verbal Learning Test (HVLT) Delayed Recall
Tidsramme: Baseline, 6 months, 12 months
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Hopkins Verbal Learning Test (HVLT) Delayed Recall. It is a paper-based assessment used to evaluate delayed verbal memory retention and recall capacity. After a standard delay interval (typically 20 to 25 minutes) following the initial learning trials, participants are asked to freely recall the original list of 12 words. The delayed recall score is the total number of words correctly recalled from memory. The score ranges from a minimum of 0 to a maximum of 12. Higher values represent a greater number of words retained and recalled after the delay, indicating better memory retention (a better outcome). Lower scores indicate worse memory retention (a worse outcome). |
Baseline, 6 months, 12 months
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Trail Making Test (TMT) Parts A
Tidsramme: Baseline, 6 months, and 12 months
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Number Correct Line Segments. This is a performance-based metric derived from the Trail Making Test (TMT) used to assess visual search, scanning, processing speed, and executive function, particularly when a participant is unable to complete the full timed test. The score is calculated by counting the total number of correct line segments a participant successfully draws connecting the sequences of encircled numbers (or numbers and letters) within the allotted test parameters. The score ranges from a minimum of 0 to a maximum of 25. Higher values represent a greater number of correctly drawn segments, indicating better cognitive processing speed and executive functioning (a better outcome). Lower values indicate worse cognitive performance (a worse outcome). |
Baseline, 6 months, and 12 months
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Trail Making Test (TMT) Parts B
Tidsramme: Baseline, 6 months, and 12 months
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Number Correct Line Segments (TMT Part B). This is a performance-based metric derived from the Trail Making Test Part B used to assess executive function, cognitive flexibility, and visual-motor tracking. It is particularly useful for quantifying performance when a participant is unable to complete the full timed test. The score is calculated by counting the total number of correct line segments a participant successfully draws connecting the 25 encircled numbers and letters in an alternating sequence (1, A, 2, B, 3, C...) within the allotted test parameters. The score ranges from a minimum of 0 to a maximum of 25. Higher values represent a greater number of correctly drawn segments, indicating better cognitive flexibility and executive functioning (a better outcome). Lower values indicate worse cognitive performance (a worse outcome). |
Baseline, 6 months, and 12 months
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Digit-Symbol Substitution Test (DSST) Number of Correct Responses
Tidsramme: Baseline, 6 months, and 12 months
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Digit-Symbol Substitution Test (DSST), utilizing the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding subtest. It is a paper-based assessment used to evaluate processing speed, visual-motor coordination, and sustained attention. Participants are provided a key pairing numbers (1 through 9) with simple geometric symbols. They are given a strict time limit (120 seconds) to draw the correct corresponding symbols beneath a series of randomized numbers. The final score is the total number of correctly drawn symbols within the time limit. The score ranges from a minimum of 0 to a maximum of 135 (the maximum possible items on the WAIS-IV Coding form). Higher values represent a greater number of correctly matched symbols, indicating faster processing speed and better cognitive performance (a better outcome). Lower scores indicate slower processing speed (a worse outcome). |
Baseline, 6 months, and 12 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Medication Perceptions
Tidsramme: 12 months
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Medication Perceptions Questionnaire. It is a 9-item survey developed in-house (adapted from Health Belief Model constructs and the revised Patients' Attitudes Towards Deprescribing Questionnaire) to assess participants' beliefs and attitudes regarding their medications and deprescribing. Participants rate items on a 5-point Likert agreement scale. The final score is calculated as a subscale average of the answered items (which allows for missing data if a participant skipped a question). The subscale average score ranges from a minimum of 1 to a maximum of 5. Higher scores indicate more disagreement (less agreement) with the survey statements. Lower scores indicate stronger agreement. The clinical favorability (better/worse outcome) depends on the specific construct of the subscale statement. |
12 months
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Self-reported Deprescribing Behavior
Tidsramme: 12 months
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The Self-Reported Deprescribing Behavior Survey is an in-house, 4-item questionnaire designed to assess a participant's self-reported actions and behaviors related to stopping or reducing their medications (deprescribing). Item Scoring: Participants rate each of the 4 items individually using a 5-point Likert scale (1 = Strongly Agree, 5 = Strongly Disagree). Score Generation: The scores of the 4 individual items are mathematically averaged to calculate a single overall composite score. Scale Range: The overall composite average score ranges from a minimum of 1 to a maximum of 5. Outcome Direction: Lower overall average values (closer to 1) indicate stronger agreement with active deprescribing behaviors, which represents a better clinical outcome. Higher overall average values (closer to 5) indicate greater disagreement, which represents a worse clinical outcome. |
12 months
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Technology Use-
Tidsramme: 12 months
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Proportion of months out of the total study time the participant logged into the application at least once.
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12 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Richard J Holden, PhD, Indiana University
Publikationer og nyttige links
Generelle publikationer
- Abebe E, Campbell NL, Clark DO, Tu W, Hill JR, Harrington AB, O'Neal G, Trowbridge KS, Vallejo C, Yang Z, Bo N, Knight A, Alamer KA, Carter A, Valenzuela R, Adeoye P, Boustani MA, Holden RJ. Reducing anticholinergic medication exposure among older adults using consumer technology: Protocol for a randomized clinical trial. Res Social Adm Pharm. 2021 May;17(5):986-992. doi: 10.1016/j.sapharm.2020.10.010. Epub 2020 Oct 22.
- Hill JR, Harrington AB, Adeoye P, Campbell NL, Holden RJ. Going Remote-Demonstration and Evaluation of Remote Technology Delivery and Usability Assessment With Older Adults: Survey Study. JMIR Mhealth Uhealth. 2021 Mar 4;9(3):e26702. doi: 10.2196/26702.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1811254189
- R01AG056926 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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