Itaca App vs. Usual Care for Medication Adherence in Older Adults on Polypharmacy
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Lazio
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Rome, Lazio, Italië, 00100
- Local Health Unit
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Intervention group: Itaca app mobile
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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) (subject to prior authorization and/or licensing for use) to evaluate perceived app usability. |
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Actieve vergelijker: Control group: Usual Care
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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Medication Adherence Score Levels
Tijdsspanne: From enrollment to end of treatment at 3 months
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Primary outcome is the change in adherence level measured by the Medication Adherence Report Scale (MARS 5I), subject to prior authorization and/or licensing for use.
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From enrollment to end of treatment at 3 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Patient Health Engagement Score Levels
Tijdsspanne: From enrollment to 3 months
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Change in patient health engagement score measured by the PHE-s, subject to prior authorization and/or licensing for use.
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From enrollment to 3 months
|
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Change in Health-Related Quality of Life Score Levels
Tijdsspanne: From enrollment to 3 months
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Change in health-related quality of life score measured by the SF-12, subject to prior authorization and/or licensing for use.
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From enrollment to 3 months
|
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App Usability Score Levels
Tijdsspanne: At the end of the intervention period, with a duration of 3 months
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Usability measured by the System Usability Scale (SUS), subject to prior authorization and/or licensing for use, assessed only in the intervention group
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At the end of the intervention period, with a duration of 3 months
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 7889 (CTEP)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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