- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04121858
Brain Safe: Forbrukerintervensjon for å redusere eksponering for medisiner knyttet til Alzheimers sykdom
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Denne studien er en randomisert klinisk studie (RCT) av effekten av en direkte til forbrukerintervensjon kalt Brain Safe for å primært redusere eldre voksnes eksponering for reseptbelagte antikolinergika og sekundært forbedre kognitiv funksjon og helserelatert livskvalitet. I løpet av 42 måneder vil forsøket registrere 700 eldre voksne i lokalsamfunnet som ble foreskrevet ett eller flere sterke antikolinergika. Deltakerne vil bli randomisert til å bruke Brain Safe-appen eller en app for oppmerksomhetskontroll medikamentliste i 12 måneder, med månedlige brukspåminnelser.
Hovedmålet er å teste effekten av Brain Safe på antikolinergisk eksponering ved 12 måneder. Vi antar at antikolinerg eksponering vil være lavere blant de som er randomisert til Brain Safe-intervensjonen sammenlignet med de som er randomisert til oppmerksomhetskontrollappen etter 12 måneder. Vårt primære, drevne utfall er den totale standard daglig dose (TSDD) mål for antikolinerg eksponering ved 12 måneder, som er beregnet over de foregående 6 månedene med reseptdata. Vi vil elektronisk fange reseptdata månedlig og beregne TSDD ved baseline, 6 og 12 måneder.
Det sekundære målet er å teste effekten av Brain Safe på: (a) kognitiv funksjon og (b) helserelatert livskvalitet ved 12 måneder. Vi antar at eldre voksne randomisert til Brain Safe vil ha høyere (a) kognitiv funksjon, målt ved å bruke en objektiv, prestasjonsbasert kompositt, og (b) helserelatert livskvalitet (HRQOL), sammenlignet med de som er randomisert til oppmerksomhetskontrollen app, ved 12 måneder.
Utforskende mål er å teste effekten av Brain Safe på antikolinerg eksponering, kognitiv funksjon og HRQOL etter 6 måneder. Dette målet vil utforske tilstedeværelsen av tidlige effekter av Brain Safe ved 6 måneder.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Indiana
-
Indianapolis, Indiana, Forente stater, 46202
- Indiana University
-
Indianapolis, Indiana, Forente stater, 46202
- IU Health
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- ≥ 1 primærhelsebesøk hos Eskenazi Health eller IU Health de siste 12 månedene
- Alder ≥ 60 år
- Skriftlig informert samtykke og HIPAA-godkjenning for utgivelse av personlig helseinformasjon.
- Engelsktalende
- Minst én resept på en sterk antikolinerg medisin med antikolinergisk kognitiv byrde (ACB) score 2 eller 3 i løpet av de siste 12 månedene, og bruker den for tiden
- Samfunnsbolig i Central Indiana
- Ikke kognitivt svekket
- Ikke dødssyk
- Ikke sensorisk svekket (etter korrigering)
Ekskluderingskriterier:
- Fast bosatt på utvidet omsorgsinstitusjon (sykehjem); selvstendig eller assistert eldreomsorgsopphold er tillatt hvis du administrerer egne medisiner.
- Diagnose av Alzheimers sykdom eller relatert demens (ADRD), bestemt av International Classification of Diseases (ICD)-9/ICD-10-koder eller nåværende bruk av et medikament for ADRD
- Diagnose av schizofreni, bipolar lidelse eller schizoaffektiv lidelse definert av ICD-9/ICD-10-koder
- Involvering i en annen klinisk studie som ville forhindre eller forstyrre studiemålene
- Sensorisk eller annen svekkelse som forbyr bruk av en mobil berøringsskjerm eller annen studieaktivitet (etter korrigering)
- Bruker ikke antikolinerge medisiner for øyeblikket
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Brain Safe App
1) Brain Safe-appen gir samtalestartere for eldre voksne pasienter som bruker antikolinergika.
Samtalestarterne hjelper pasienten til å ha diskusjoner med sine leger om reduksjon i eksponering for reseptbelagte antikolinergika.
2) Gir antikolinergisk risikovurdering.
|
Brain Safe-appen inkluderer medisinlisten, en personlig risikokalkulator, pedagogisk multimedieinnhold og en samtalestarter/legerapport.
|
|
Sham-komparator: Appen for oppmerksomhetskontroll
1) Oppmerksomhetskontroll-appen gir en medisinliste for eldre pasienter å bruke, men mangler samtalestarterne for pasienten å bruke med sine leger med sikte på å redusere eksponeringen for reseptbelagte antikolinergika.2)
Ingen antikolinergisk risikovurdering.
|
Appen for oppmerksomhetskontroll, kalt Med Safe, inkluderer bare medisinlistefunksjonen.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Total Standardized Daily Dose (TSDD) - From Medical Records
Tidsramme: Baseline, 6 months, 12 Months
|
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
|
|
Log Transformed Total Standardized Daily Dose (TSDD) - From Medical Records
Tidsramme: Baseline, 6, and 12 Months
|
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).
|
Baseline, 6, and 12 Months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Cognitive Score
Tidsramme: Baseline, 6 months, and 12 months
|
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
|
|
Choice Reaction Time (CRT)
Tidsramme: Baseline
|
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
|
|
Health Utilities Index (HUI) Mark 3
Tidsramme: Baseline, 6 months, and 12 months
|
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
|
|
Hopkins Verbal Learning Test (HVLT) Total Recall
Tidsramme: Baseline, 6 months, and 12 months
|
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
|
|
Hopkins Verbal Learning Test (HVLT) Delayed Recall
Tidsramme: Baseline, 6 months, 12 months
|
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
|
|
Trail Making Test (TMT) Parts A
Tidsramme: Baseline, 6 months, and 12 months
|
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
|
|
Trail Making Test (TMT) Parts B
Tidsramme: Baseline, 6 months, and 12 months
|
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
|
|
Digit-Symbol Substitution Test (DSST) Number of Correct Responses
Tidsramme: Baseline, 6 months, and 12 months
|
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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Medication Perceptions
Tidsramme: 12 months
|
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
|
|
Self-reported Deprescribing Behavior
Tidsramme: 12 months
|
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
|
|
Technology Use-
Tidsramme: 12 months
|
Proportion of months out of the total study time the participant logged into the application at least once.
|
12 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Richard J Holden, PhD, Indiana University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1811254189
- R01AG056926 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .