Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care

Study Overview
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Brief Summary
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To develop, using barcode systems and virtual pillbox (TuMedicina and Alice), an App aimed at patients and carers of patients with cardiometabolic diseases as the main diagnosis, over 45 years of age, who have one or more pathologies and use one or more drugs on a daily basis and to analyze their effectiveness in terms of achieving therapeutic objectives, self-efficacy and self-efficacy in self-care or provision of care (as the case may be), healthy behavior, therapeutic compliance and safe use of medication.

Detailed Description
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In order to achieve the objective of this study, an experimental study will carry out on patients with cardiometabolic and respiratory diseases and their caregivers. A participation of 100 patients and 85 caregivers is planned. The aim is for them to use the mobile application developed over three months in order to evaluate their health improvement comparing several clinical and analytic parameters before and after the use of the App, and also evaluating the satisfaction of the participants.

Official Title
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Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care

Conditions
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Copd, Hypertension, Diabetes, Heart Failure, Asthma, Obesity

Intervention / Treatment
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* Device: Mobile application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardio-metabolic disease, respiratory disease or neurologic disease Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental hypertension<br>The subjects with Hypertension will be trained in the use of the personalized help tool and will use it during a period of 3 months. | Device: Mobile application<br>* Experimental group will use a mobile application to help them in their self-care<br>|
| Experimental: experimental diabetes<br>The subjects with Diabetes will be trained in the use of the personalized help tool and will use it during a period of 3 months. | Device: Mobile application<br>* Experimental group will use a mobile application to help them in their self-care<br>|
| Experimental: experimental heart failure<br>The subjects with Heart failure will be trained in the use of the personalized help tool and will use it during a period of 3 months. | Device: Mobile application<br>* Experimental group will use a mobile application to help them in their self-care<br>|
| Experimental: experimental copd<br>The subjects with COPD will be trained in the use of the personalized help tool and will use it during a period of 3 months. | Device: Mobile application<br>* Experimental group will use a mobile application to help them in their self-care<br>|
| Experimental: experimental asthma<br>The subjects with Asthma will be trained in the use of the personalized help tool and will use it during a period of 3 months. | Device: Mobile application<br>* Experimental group will use a mobile application to help them in their self-care<br>|
| Experimental: experimental obesity<br>The subjects with Obesity will be trained in the use of the personalized help tool and will use it during a period of 3 months. | Device: Mobile application<br>* Experimental group will use a mobile application to help them in their self-care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the mobile application assessed by an ad hoc questionnaire | % of participants who were satisfied with the mobile application assessed by an ad hoc questionnaire | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment adherence assessed by Morisky Medication Adherence Scale (MMAS) | % of participants who improve their treatment adherence assessed by Morisky Medication Adherence Scale (MMAS) | 3 months |