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ACTIVE NOT RECRUITING
NCT07631676
NA

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

Sponsor: University of Roma La Sapienza

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2025-11-26

Completion Date

2026-11

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

OTHER

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.

OTHER

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.

Locations (1)

Local Health Unit

Rome, Lazio, Italy