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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04159558
• Other study ID #: 18/324
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: June 2020
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Cardio-metabolic disease, respiratory disease or neurologic disease

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Asthma
• Copd
• Diabetes
• Heart Failure
• Hypertension
• Obesity

Intervention

Device:
• Mobile application
Experimental group will use a mobile application to help them in their self-care

Locations

Country	Name	City	State
Spain	Miguel Hernández University	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health goals compliance assessed by an ad hoc questionnaire	% of participants who compliance their health goals assessed by an ad hoc questionnaire	3 months
Primary	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	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