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

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Disease; Medication Adherence; Poly Pharmacy; Older Adults (65 Years and Older)
• Intervention / Treatment: Other: mobile app; Other: Usual Care Group

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group: Itaca app mobile	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) to evaluate perceived app usability.
Active Comparator: Control group: Usual Care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Medication Adherence Score Levels	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Engagement Score Levels	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	Change in health-related quality of life score measured by the SF-12	From enrollment to 3 months
Change in Patient Activation Score Levels	Change in patient activation measured by the PAM-13	From enrollment to 3 months
App Usability Score Levels	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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: June 3, 2026
• First Posted (Actual): June 8, 2026

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 3, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: older adults; mobile health; medication adherence; chronic conditions
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Compliance; Patient Acceptance of Health Care; Chronic Disease; Medication Adherence
• Other Study ID Numbers: 7889 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No