- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04221789
TB-behandlingsstøtteværktøj Interaktiv mobilapp og overvågning af direkte overholdelse af TB-behandlingsresultater (TB-TST)
TB-behandlingsstøtteværktøjer: Forfining og evaluering af en interaktiv mobilapp og direkte overholdelsesovervågning af resultaterne af TB-behandling
Det overordnede mål med denne undersøgelse er at gennemføre et randomiseret klinisk forsøg (RCT) for at evaluere et støtteværktøj til tuberkulosebehandling (TB-TST), en mobiltelefon-app udviklet ved hjælp af brugercentrerede designprincipper og en papirbaseret urinteststrimmel for lægemiddelmetabolit. modificeret til hjemmebrug for at teste tilstedeværelsen af isoniazid-lægemiddelmetabolitter i urin for direkte at overvåge overholdelse af behandlingen, for at forbedre behandlingsresultater for patienter med TB, der modtager selvadministreret behandling (SAT).
Dårlig overholdelse af medicin til TB-regimer, sammen med udfordringer med at monitorere patienter og returnere dem til behandling, er vigtige medvirkende faktorer til dårlige resultater og udvikling af lægemiddelresistens. Med fremskridt og udbredelse af mobile teknologiplatforme er der stor interesse for den mulige brug af mobile sundhedsinterventioner (mHealth) til at løse disse udfordringer. Af de mHealth-tilgange, der undersøges til overvågning af TB-overholdelse, er testning af lægemiddelmetabolit blevet identificeret som den mest lovende, etiske og nøjagtige og den mindst påtrængende og stigmatiserende strategi sammenlignet med andre mobile løsninger, men dens potentiale forbliver stort set uudforsket. Derudover kan mobilapplikationer (apps) give personlig behandlingssupervision, øge patienternes selvstyring og forbedre patient-udbyderkommunikation ved at tilbyde mere avancerede funktionaliteter til patientstøtte og overvågning.
Den eksisterende version af TB-TST-appen tilbyder undervisning om TB og dens behandling, kommunikation med en plejekoordinator, sporer behandlingsoverholdelse (både ved selvrapportering og direkte metabolitteststrimmelbilleder), selvrapporterer behandlingsbivirkninger og beholder patientens "dagbogs"-notater. Dette forslag bygger på det foreløbige arbejde med at: 1) Forfine TB-TST-interventionen baseret på pilotundersøgelsesresultater og anvende principper for brugercentreret design; 2) Evaluer virkningen af TB-TST på behandlingsresultater sammenlignet med sædvanlig pleje; 3) Vurder patient og udbyders opfattelse af facilitatorer og barrierer for implementering af TB-TST og syntetisere erfaringer med interessenter og politiske beslutningstagere. Det primære resultat vil være behandlingssucces. Sekundære resultater vil omfatte: misligholdelsesrater for behandling, selvrapporteret overholdelse, teknologibrug og anvendelighed. Resultaterne har bredere implikationer, ikke kun for TB-adhærens, men sygdomshåndtering mere generelt og vil forbedre vores forståelse af, hvordan vi kan støtte patienter, der står over for udfordrende behandlingsregimer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Fernando A Rubinstein, MD MPH
- Telefonnummer: +54 11 47778767
- E-mail: frubinstein@iecs.org.ar
Undersøgelse Kontakt Backup
- Navn: Sarah Iribarren, RN PhD
- Telefonnummer: 206 543 5211
- E-mail: sjiribar@uw.edu
Studiesteder
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-
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Buenos Aires, Argentina, 1414
- IECS
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Deltagerne skal være mindst 16 år,
- har en ny diagnose af medicinmodtagelig TB,
- Første behandling
- har regelmæssig adgang til en smartphone, og
- være i stand til at betjene telefonen eller have nogen, der kan hjælpe.
Ekskluderingskriterier:
- Børn op til 15 år
- Genbehandling (standard eller tidligere behandlingssvigt)
- Patienter, der er alvorligt syge (dvs. kræver indlæggelse)
- Patienter, der bor i samme husstand med en anden undersøgelsesdeltager
- Manglende evne til at betjene en smartphone
- Analfabetisme (manglende evne til at læse og skrive)
- Patienter med kendt lægemiddelresistens
- Patienter med kendt HIV co-infektion vil blive udelukket, fordi deres pleje administreres separat.
- Screenede patienter, som ikke opfylder undersøgelsesberettigelsen, vil få specifikke screeningsdata (inklusive køn, alder og udelukkelsesårsag) indtastet i undersøgelsesdatabasen for at undersøge årsager til udelukkelse og gennemførlighed af tilmeldingskriterier.
Casedefinition: Patienter på mindst 16 år med TB bekræftet af udstrygningspositivt opspyt eller diagnose af lunge-TB baseret på radiologiske fund og kliniske tegn og symptomer, men med negativ opspytudstrygning. Diagnosen kan bekræftes med andre metoder, såsom MGIT960, BACTEC 9000 eller MB Bact, nukleinsyreamplifikation (PCR) eller ELISA.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: intervention: TB-behandlingsassistent
Patienter, der modtager instruktioner om at bruge telefonapplikationen
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Mobiltelefonapp til at understøtte selvadministreret behandling og overvåge overholdelse
Andre navne:
|
Ingen indgriben: Styring
Patienter, der modtager instruktioner om sædvanlig pleje selvadministreret behandling
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Behandlings succes
Tidsramme: 6 måneder
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Afslutning af behandling og/eller helbredelse
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6 måneder
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Behandlingsstandard
Tidsramme: 6 måneder
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Afbrydelse af behandlingen i mindst 2 måneder
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6 måneder
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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Fernando A Rubinstein, MD MPH, Institute for Clinical Effectiveness and Health Policy
- Ledende efterforsker: Sarah Iribarren, RN PhD, University of Washington
Publikationer og nyttige links
Generelle publikationer
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Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
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
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Yderligere relevante MeSH-vilkår
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West China HospitalIkke rekrutterer endnuKunstig intelligens | Atopisk dermatitis
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Last Mile HealthMassachusetts General Hospital; Northwestern University; Georgetown University og andre samarbejdspartnereAktiv, ikke rekrutterendeDiarré | Malaria | Akut luftvejsinfektion | Underernæring, barnLiberia
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Peter MacCallum Cancer Centre, AustraliaAktiv, ikke rekrutterendeProstatakræft | Metastatisk kastrationsresistent prostatakræftAustralien
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Yale UniversityNational Institutes of Health (NIH)Ikke rekrutterer endnuHIV | TuberkuloseUganda
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Assistance Publique - Hôpitaux de ParisAfsluttetHIV | Tuberkulose | Latent tuberkuloseinfektionFrankrig
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Boston CollegeBoston University; National Institute of Nursing Research (NINR); National... og andre samarbejdspartnereIkke rekrutterer endnuTuberkulose | TB - Tuberkulose | TPTSydafrika