Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started Apr 2018
Longer than P75 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2018
CompletedFirst Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedJune 23, 2020
June 1, 2020
3.5 years
November 7, 2019
June 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)
3 months
Other Outcomes (1)
Health goals compliance assessed by an ad hoc questionnaire
3 months
Study Arms (6)
experimental hypertension
EXPERIMENTALThe subjects with Hypertension will be trained in the use of the personalized help tool and will use it during a period of 3 months.
experimental diabetes
EXPERIMENTALThe subjects with Diabetes will be trained in the use of the personalized help tool and will use it during a period of 3 months.
experimental heart failure
EXPERIMENTALThe 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.
experimental copd
EXPERIMENTALThe subjects with COPD will be trained in the use of the personalized help tool and will use it during a period of 3 months.
experimental asthma
EXPERIMENTALThe subjects with Asthma will be trained in the use of the personalized help tool and will use it during a period of 3 months.
experimental obesity
EXPERIMENTALThe subjects with Obesity will be trained in the use of the personalized help tool and will use it during a period of 3 months.
Interventions
Experimental group will use a mobile application to help them in their self-care
Eligibility Criteria
You may qualify if:
- Cardio-metabolic disease, respiratory disease or neurologic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Miguel Hernández University
Elche, Alicante, 03202, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Professor with a related position as Clinical Psychologist in SNS
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 12, 2019
Study Start
April 24, 2018
Primary Completion
October 31, 2021
Study Completion
October 31, 2021
Last Updated
June 23, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share