Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Itaca App vs. Usual Care for Medication Adherence in Older Adults on Polypharmacy

3. juni 2026 opdateret af: Marco Di Muzio, University of Roma La Sapienza

Monitoring Medication Adherence in Patients Aged ≥65 Years on Polypharmacy: A Randomized Clinical Trial of the Itaca Mobile App vs. Usual Care

The goal of this clinical trial is to learn if the use of a mobile app called Itaca improves medication adherence in older adults (aged ≥65) in a home care setting. It will also assess the impact of the app on patient engagement, patient activation, quality of life, and the app's usability in the intervention group. The main question it aims to answer is:

  • Does the use of the Itaca mobile application improve medication adherence among older adults in the home care setting compared with usual care?
  • Does the use of the Itaca mobile application improve patient engagement, patient activation, and quality of life among older adults in the home care setting compared with usual care?

Researchers will compare usual care to see if the intervention using the Itaca mobile app is more effective in improving medication adherence.

Participants will:

  • In the intervention group, use the Itaca app for 3 months
  • In the intervention group, receive monthly phone calls to support adherence to the study protocol, monitor app use, and address any barriers
  • In the intervention group, complete the usability scale at the end of the 3-month intervention period
  • In both the intervention and control groups, complete the questionnaires at enrollment and after 3 months, at the end of the intervention period

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

98

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
    • Lazio
      • Rome, Lazio, Italien, 00100
        • Local Health Unit

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Age ≥ 65 years with chronic condition
  • Taking three or more medications regardless of route of administration
  • Able to understand and speak Italian and to adhere to the study by signing written informed
  • Able to understand and speak Italian and to adhere to the study by signing written informed

Exclusion Criteria:

  • Pediatric or adult (< 65 years)
  • Taking fewer than three medications
  • With diagnosed cognitive impairment or psychiatric disorder that could interfere with participation in the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention group: Itaca app mobile
Andet: mobile app

At baseline (T0), the research team will support participants in installing the ITACA application on their personal smartphone. An individual training session will be provided at T0. Medication reminder notifications will be activated according to each patient's prescribed regimen.

The application will be used throughout the entire 3-month follow-up period. Researchers will contact participants by telephone at monthly intervals to monitor app use and address barriers. No formal assessments are performed at these contacts. At 3 months (T1), participants will complete the System Usability Scale (SUS) to evaluate perceived app usability.
Aktiv komparator: Control group: Usual Care
Andet: Usual Care Group

At baseline (T0), participants will receive and be provided with an explanation of a written medication plan containing prescribed therapies, dosages, and administration schedules.

Participants will continue standard clinical follow-up with their GP throughout the 3-month period.

No digital tools or additional interventions will be provided beyond routine clinical practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Medication Adherence Score Levels
Tidsramme: From enrollment to end of treatment at 3 months
Primary outcome is the change in adherence level measured by the Morisky Medication Adherence Scale (MMAS-4)
From enrollment to end of treatment at 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Patient Health Engagement Score Levels
Tidsramme: From enrollment to 3 months
Change in patient health engagement score measured by the PHE-s
From enrollment to 3 months
Change in Health-Related Quality of Life Score Levels
Tidsramme: From enrollment to 3 months
Change in health-related quality of life score measured by the SF-12
From enrollment to 3 months
Change in Patient Activation Score Levels
Tidsramme: From enrollment to 3 months
Change in patient activation measured by the PAM-13
From enrollment to 3 months
App Usability Score Levels
Tidsramme: At the end of the intervention period, with a duration of 3 months
Usability measured by the System Usability Scale (SUS), assessed only in the intervention group
At the end of the intervention period, with a duration of 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Roma La Sapienza

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. november 2025

Primær færdiggørelse (Anslået)

1. oktober 2026

Studieafslutning (Anslået)

1. november 2026

Datoer for studieregistrering

Først indsendt

22. maj 2026

Først indsendt, der opfyldte QC-kriterier

3. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 7889 (CTEP)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk sygdom

Kliniske forsøg med mobile app

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sri Lanka

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner