HypertensionNCT04159558
Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care
A study testing Mobile application in people with Hypertension and Diabetes, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypertension, Diabetes, Heart Failure
- What is being tested?
- Mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 24 Apr 2018to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Cardio-metabolic disease, respiratory disease or neurologic disease
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Miguel Hernández University
Elche, Alicante, 03202
José Joaquín Mira, Psychology, 606433599 ext. +34, jose.mira@umh.es
About this study
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.
Read the 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.
- Conditions
- Hypertension, Diabetes, Heart Failure, Copd, Asthma, Obesity
- Being tested
- Mobile application
- Medical subject headings
- Hypertension, Diabetes Mellitus, Heart Failure, Pulmonary Disease, Chronic Obstructive, Asthma, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationDevice
Experimental group will use a mobile application to help them in their self-care
| Study group | Role | What they receive |
|---|---|---|
| experimental hypertension | Experimental | 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. Receives: Device: Mobile application |
| experimental diabetes | Experimental | 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. Receives: Device: Mobile application |
| experimental heart failure | Experimental | 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. Receives: Device: Mobile application |
| experimental copd | Experimental | 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. Receives: Device: Mobile application |
| experimental asthma | Experimental | 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. Receives: Device: Mobile application |
| experimental obesity | Experimental | 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. Receives: Device: Mobile application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
Treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)
% of participants who improve their treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start24 Apr 2018
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Joaquín Mira, Universidad Miguel Hernandez de Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159558
- Sponsor's protocol ID
- 18/324
- Status last verified
- Jun 2020
- First submitted
- 7 Nov 2019
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of mHealth Solutions to Monitor and Involve Cardiometabolic Patients in Self-care
- ClinicalTrials.gov ID
- NCT04159558
- Acronym / sponsor ID
- 18/324
- Conditions
- Hypertension, Diabetes, Heart Failure, Copd, Asthma, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| experimental hypertension | Experimental | Device: Mobile applicationThe 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 | Experimental | Device: Mobile applicationThe 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 | Experimental | Device: Mobile applicationThe 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 | Experimental | Device: Mobile applicationThe 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 | Experimental | Device: Mobile applicationThe 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 | Experimental | Device: Mobile applicationThe subjects with Obesity will be trained in the use of the personalized help tool and will use it during a period of 3 months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Cardio-metabolic disease, respiratory disease or neurologic disease
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile applicationExperimental group will use a mobile application to help them in their self-care | Device | experimental asthma, experimental copd, experimental diabetes, experimental heart failure, experimental hypertension, experimental obesity |
Primary outcome
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
1 secondary outcome
Treatment adherence assessed by Morisky Medication Adherence Scale (MMAS)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application in people with Hypertension and Diabetes, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with the mobile application assessed by an ad hoc questionnaire (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.