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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159558
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
José Joaquín Mira, 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.

Condition or disease Intervention/treatment Phase
Hypertension Diabetes Heart Failure Copd Asthma Obesity Device: Mobile application Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

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




Primary Outcome Measures :
  1. Satisfaction with the mobile application assessed by an ad hoc questionnaire [ Time Frame: 3 months ]
    % of participants who were satisfied with the mobile application assessed by an ad hoc questionnaire


Secondary Outcome Measures :
  1. Treatment adherence assessed by Morisky Medication Adherence Scale (MMAS) [ Time Frame: 3 months ]
    % of participants who improve their treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)


Other Outcome Measures:
  1. Health goals compliance assessed by an ad hoc questionnaire [ Time Frame: 3 months ]
    % of participants who compliance their health goals assessed by an ad hoc questionnaire



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cardio-metabolic disease, respiratory disease or neurologic disease

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159558


Locations
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Spain
Miguel Hernández University Recruiting
Elche, Alicante, Spain, 03202
Contact: José Joaquín Mira, Psychology    606433599 ext +34    jose.mira@umh.es   
Sponsors and Collaborators
Universidad Miguel Hernandez de Elche
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Responsible Party: José Joaquín Mira, University Professor with a related position as Clinical Psychologist in SNS, Universidad Miguel Hernandez de Elche
ClinicalTrials.gov Identifier: NCT04159558    
Other Study ID Numbers: 18/324
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases