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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure; Hypertension; Obesity; Diabetes; Asthma; Copd
• Intervention / Treatment: Device: Mobile application

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Recruiting
      • Miguel Hernandez University
      • Contact: José Joaquín Mira, Psychology; Phone Number: +34 606433599; Email: jose.mira@umh.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Cardio-metabolic disease, respiratory disease or neurologic disease

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Mobile application; Experimental group will use a mobile application to help them in their self-care
Experimental: 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.	Device: Mobile application; Experimental group will use a mobile application to help them in their self-care
Experimental: 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.	Device: Mobile application; Experimental group will use a mobile application to help them in their self-care
Experimental: 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.	Device: Mobile application; Experimental group will use a mobile application to help them in their self-care
Experimental: 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.	Device: Mobile application; Experimental group will use a mobile application to help them in their self-care
Experimental: 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.	Device: Mobile application; Experimental group will use a mobile application to help them in their self-care

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health goals compliance assessed by an ad hoc questionnaire	% of participants who compliance their health goals assessed by an ad hoc questionnaire	3 months

Collaborators and Investigators

• Sponsor: Universidad Miguel Hernandez de Elche

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2020
• Last Update Submitted That Met QC Criteria: June 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 18/324

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No