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Clinical Trials in Italy / NCT07631676
Active, not recruiting Not applicable

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

NCT07631676 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-11-26
Last updated
2026-07-10

Condition(s) studied

Medication AdherencePoly PharmacyChronic DiseaseOlder Adults (65 Years and Older)

Investigational drug(s) / intervention(s)

mobile appUsual Care Group

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) (subject to prior authorization and/or licensing for use) to evaluate perceived app usability.

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.

Study summary

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

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Local Health Unit Rome Lazio

More University of Roma La Sapienza trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07631676 on ClinicalTrials.gov ↗ ← All trials in Italy