Itaca App vs. Usual Care for Medication Adherence in Older Adults on Polypharmacy
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?
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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Lazio
-
Rome, Lazio, Italie, 00100
- Local Health Unit
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention group: Itaca app mobile
|
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. |
|
Comparateur actif: Control group: Usual Care
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Medication Adherence Score Levels
Délai: 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.
|
From enrollment to end of treatment at 3 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Patient Health Engagement Score Levels
Délai: 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.
|
From enrollment to 3 months
|
|
Change in Health-Related Quality of Life Score Levels
Délai: 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.
|
From enrollment to 3 months
|
|
App Usability Score Levels
Délai: 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
|
At the end of the intervention period, with a duration of 3 months
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 7889 (CTEP)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .