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

NCT07631676 | Active Not Recruiting

• 1 other identifier: 7889
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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; Older Adults (65 Years and Older); Chronic Disease

Keywords

medication adherence; older adults; chronic conditions; mobile health

Outcome Measures

Primary Outcomes (1)

• Change in Medication Adherence Score Levels

  Primary outcome is the change in adherence level measured by the Morisky Medication Adherence Scale (MMAS-4), subject to prior authorization and/or licensing for use.

  From enrollment to end of treatment at 3 months

Secondary Outcomes (3)

• Change in Patient Health Engagement Score Levels

  From enrollment to 3 months

• Change in Health-Related Quality of Life Score Levels

  From enrollment to 3 months

• App Usability Score Levels

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

Study Arms (2)

Intervention group: Itaca app mobile

EXPERIMENTAL

Other: mobile app

Control group: Usual Care

ACTIVE COMPARATOR

Other: Usual Care Group

Interventions

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.

Intervention group: Itaca app mobile

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.

Control group: Usual Care

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Local Health Unit

Rome, Lazio, 00100, Italy

Location

MeSH Terms

Conditions

Medication Adherence; Chronic Disease

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 8, 2026
• Study Start: November 26, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)