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

NCT ID: NCT04159558

Last Updated: 2020-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2021-10-31

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.

Conditions

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Hypertension Diabetes Heart Failure Copd Asthma Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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experimental hypertension

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.

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

Experimental group will use a mobile application to help them in their self-care

experimental diabetes

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.

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

Experimental group will use a mobile application to help them in their self-care

experimental heart failure

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.

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

Experimental group will use a mobile application to help them in their self-care

experimental copd

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.

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

Experimental group will use a mobile application to help them in their self-care

experimental asthma

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.

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

Experimental group will use a mobile application to help them in their self-care

experimental obesity

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.

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

Experimental group will use a mobile application to help them in their self-care

Interventions

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Mobile application

Experimental group will use a mobile application to help them in their self-care

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Cardio-metabolic disease, respiratory disease or neurologic disease

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role lead

Responsible Party

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José Joaquín Mira

University Professor with a related position as Clinical Psychologist in SNS

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Miguel Hernández University

Elche, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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José Joaquín Mira, Psychology

Role: primary

606433599 ext. +34

Other Identifiers

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18/324

Identifier Type: -

Identifier Source: org_study_id

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