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Active, Not Recruiting

NCT Number: NCT07631676

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Medication Adherence Behavior Chronic Disease Disease Attributes Health Behavior Older Adults (65 Years and Older) Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Poly Pharmacy Treatment Adherence and Compliance

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Local Health Unit

Rome, Lazio, 00100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile app

Other

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

Other

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.

Primary outcomes

  1. Change in Medication Adherence Score Levels

    Time frame: From enrollment to end of treatment at 3 months

    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.

Secondary outcomes

  1. Change in Patient Health Engagement Score Levels

    Time frame: From enrollment to 3 months

    Change in patient health engagement score measured by the PHE-s, subject to prior authorization and/or licensing for use.

  2. Change in Health-Related Quality of Life Score Levels

    Time frame: From enrollment to 3 months

    Change in health-related quality of life score measured by the SF-12, subject to prior authorization and/or licensing for use.

  3. App Usability Score Levels

    Time frame: At the end of the intervention period, with a duration of 3 months

    Usability measured by the System Usability Scale (SUS), subject to prior authorization and/or licensing for use, assessed only in the intervention group

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 8, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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