Medication AdherenceNCT07631676
Itaca App vs. Usual Care for Medication Adherence in Older Adults on Polypharmacy
A study testing mobile app in people with Medication Adherence and Poly Pharmacy, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Medication Adherence, Poly Pharmacy, Chronic Disease
- What is being tested?
- mobile app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 26 Nov 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monitoring Medication Adherence in Patients Aged ≥65 Years on Polypharmacy: A Randomized Clinical Trial of the Itaca Mobile App vs. Usual Care
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?
Read more
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
- Being tested
- mobile app, Usual Care Group
- Keywords
- medication adherence, older adults, chronic conditions, mobile health
- Medical subject headings
- Medication Adherence, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile appOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: Itaca app mobile | Experimental | Not described Receives: Other: mobile app |
| Control group: Usual Care | Active comparator | Not described Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of treatment at 3 months
Secondary outcomes (3)
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.
Measured: From enrollment to 3 months
Change in Health-Related Quality of Life Score Levels
Change in health-related quality of life score measured by the SF-12, subject to prior authorization and/or licensing for use.
Measured: 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
Measured: At the end of the intervention period, with a duration of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start26 Nov 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Di Muzio, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631676
- Sponsor's protocol ID
- 7889
- Status last verified
- Jul 2026
- First submitted
- 22 May 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Medication Adherence in Patients Aged ≥65 Years on Polypharmacy: A Randomized Clinical Trial of the Itaca Mobile App vs. Usual Care
- ClinicalTrials.gov ID
- NCT07631676
- Acronym / sponsor ID
- 7889
- Keywords
- medication adherence, older adults, chronic conditions, mobile health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: Itaca app mobile | Experimental | Other: mobile app |
| Control group: Usual Care | Active comparator | Other: Usual Care Group |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile appAt 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 | Intervention group: Itaca app mobile |
| Usual Care GroupAt 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. | Other | Control group: Usual Care |
Primary outcome
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.
3 secondary outcomes
Change in Patient Health Engagement Score Levels
Time frame: From enrollment to 3 months
Change in Health-Related Quality of Life Score Levels
Time frame: From enrollment to 3 months
App Usability Score Levels
Time frame: At the end of the intervention period, with a duration of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile app in people with Medication Adherence and Poly Pharmacy, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Medication Adherence Score Levels (time frame: From enrollment to end of treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.