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

Not Applicable

• Conditions: Diabetes; Hypertension; Heart Failure; Copd; Obesity; Asthma
• Interventions: Device: Mobile application

• Registration Number: NCT04159558
• Lead Sponsor: Universidad Miguel Hernandez de Elche

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-04-24
• Study First Submitted: 2019-11-07
• Study First Submitted QC: 2019-11-08
• Study First Posted: 2019-11-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-19
• Last Update Posted: 2020-06-23
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Cardio-metabolic disease, respiratory disease or neurologic disease

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental heart failure	Mobile application	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.
experimental copd	Mobile application	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.
experimental obesity	Mobile application	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.
experimental hypertension	Mobile application	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.
experimental asthma	Mobile application	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.
experimental diabetes	Mobile application	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.

Primary Outcome Measures

Name	Time	Method
Satisfaction with the mobile application assessed by an ad hoc questionnaire	3 months	% of participants who were satisfied with the mobile application assessed by an ad hoc questionnaire

Secondary Outcome Measures

Name	Time	Method
Treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)	3 months	% of participants who improve their treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)

Trial Locations

Locations (1)

Miguel Hernández University; 🇪🇸 Elche, Alicante, Spain