Chronic Disease, Medication Adherence, Older Adults (65 Years and Older), Poly Pharmacy
Conditions
Keywords
medication adherence, older adults, chronic conditions, mobile health
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
Interventions
OTHERmobile 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.
OTHERUsual 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
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Medication Adherence Score Levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Engagement Score Levels | 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. |
| Change in Health-Related Quality of Life Score Levels | 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. |
| App Usability Score Levels | 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 |
Countries
Italy
Outcome results
None listed