Back to resultsDevelopment and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care
Primary Purpose
Hypertension, Diabetes, Heart Failure
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mobile application
Sponsored by
About this trial
This is an interventional supportive care trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Cardio-metabolic disease, respiratory disease or neurologic disease
Exclusion Criteria:
-
Sites / Locations
- Miguel Hernández UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
experimental hypertension
experimental diabetes
experimental heart failure
experimental copd
experimental asthma
experimental obesity
Arm Description
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.
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)
% of participants who improve their treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)
Full Information
NCT ID
NCT04159558
First Posted
November 7, 2019
Last Updated
June 19, 2020
Sponsor
Universidad Miguel Hernandez de Elche
1. Study Identification
Unique Protocol Identification Number
NCT04159558
Brief Title
Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care
Official Title
Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Diabetes, Heart Failure, Copd, Asthma, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental hypertension
Arm Type
Experimental
Arm Description
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.
Arm Title
experimental diabetes
Arm Type
Experimental
Arm Description
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.
Arm Title
experimental heart failure
Arm Type
Experimental
Arm Description
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.
Arm Title
experimental copd
Arm Type
Experimental
Arm Description
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.
Arm Title
experimental asthma
Arm Type
Experimental
Arm Description
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.
Arm Title
experimental obesity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Mobile application
Intervention Description
Experimental group will use a mobile application to help them in their self-care
Primary Outcome Measure Information:
Title
Satisfaction with the mobile application assessed by an ad hoc questionnaire
Description
% of participants who were satisfied with the mobile application assessed by an ad hoc questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)
Description
% of participants who improve their treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Health goals compliance assessed by an ad hoc questionnaire
Description
% of participants who compliance their health goals assessed by an ad hoc questionnaire
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cardio-metabolic disease, respiratory disease or neurologic disease
Exclusion Criteria:
-
Facility Information:
Facility Name
Miguel Hernández University
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Joaquín Mira, Psychology
Phone
606433599
Ext
+34
Email
jose.mira@umh.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care
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