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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:
Researchers will compare usual care to see if the intervention using the Itaca mobile app is more effective in improving medication adherence.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group: Itaca app mobile | Experimental |
| |
| Control group: Usual Care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Medication Adherence Score Levels | 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. | From enrollment to end of treatment at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Health Engagement Score Levels | Change in patient health engagement score measured by the PHE-s, subject to prior authorization and/or licensing for use. | From enrollment to 3 months |
| Change in Health-Related Quality of Life Score Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Health Unit | Rome | Lazio | 00100 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2026 | Jul 8, 2026 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| 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. |
|
Change in health-related quality of life score measured by the SF-12, subject to prior authorization and/or licensing for use. |
| From enrollment to 3 months |
| App Usability Score Levels | Usability measured by the System Usability Scale (SUS), subject to prior authorization and/or licensing for use, assessed only in the intervention group | At the end of the intervention period, with a duration of 3 months |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |