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

NCT07631676 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-07-10

No results posted yet for this 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

Conditions

  • Medication Adherence
  • Poly Pharmacy
  • Chronic Disease
  • Older Adults (65 Years and Older)

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.

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-26
Primary Completion
2026-10-31
Completion
2026-11-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07631676 on ClinicalTrials.gov