AsthmamINSPIRERS_RCTNCT05129527
Effect of a Mobile App on Improving Asthma Control in Patients With Persistent Asthma
A study testing InspirerMundi app in people with Asthma, run by Universidade do Porto at 1 site in Portugal.
Trial summary
mINSPIRERS_RCT aims to assess the magnitude of the effect of a mobile app for improving asthma control in adolescents and adults with persistent asthma, followed at primary and secondary care in Portugal. Read more about this study
- Who is it for?
- Ages 13 to 64 years
- Conditions the study is for
- Asthma
- What is being tested?
- InspirerMundi app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2024to Dec 2024
- 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 13 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 13 and 17 years (adolescents) or and between 18 and 64 years (adults);
- Previous medical diagnosis of persistent asthma;
- Uncontrolled or partially controlled asthma according to Global Initiative for Asthma (GINA) criteria;
- Active prescription of inhaled control medication for asthma (all treatments will be accepted. There will be no change in the prescribed therapeutic regimen directly or indirectly related to participation in this study);
- Ability to use mobile app and a access (availability and use) to Android mobile devices with internet access;
- Do not currently use any mobile application for asthma management.
Who cannot join
- Patients diagnosed with chronic respiratory disease other than asthma or, diagnosed with another significant chronic disease, with possible interference with the objectives and/or evaluations of the study.
- Patients that participated in previous feasibility studies with InspirerMundi app will be excluded.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculty of Medicine of the University of Porto
Porto, 4200-319
Cristina Jácome, PhD, cjacome@med.up.pt
About this study
Official title: Effect of a Mobile App on Improving Asthma Control in Adolescents and Adults With Persistent Asthma: A Pilot Randomized Multicentre, Superiority Clinical Trial
mINSPIRERS_RCT aims to assess the magnitude of the effect of a mobile app for improving asthma control in adolescents and adults with persistent asthma, followed at primary and secondary care in Portugal.
Read the detailed description
INSPIRERS_RCT is a pilot randomized, multicenter superiority clinical trial regarding the effect of a mobile app together with usual care (experimental group) in comparison to usual care alone (control group) in adolescents and adults with persistent asthma. The study includes two face-to-face visits (initial visit and at 3 months), and 3 telephone interviews (1 week, 1 month and 4 months), implemented in 32 primary (General Practice) and secondary care centers (Allergy, Pediatrics, Pulmonology) in Portugal.
- Conditions
- Asthma
- Being tested
- InspirerMundi app, Usual care
- Keywords
- mHealth, smartphone, medication adherence, self-management, technology assessment
- Medical subject headings
- Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InspirerMundi appDevice
Patients in the experimental group, in addition to usual care, will be invited to use the InspirerMundi app for 4 months to support adherence to preventive inhaled medication and their asthma self-management. The purpose of the InspirerMundi app is to transform the adherence process into a positive experience through immediate and pleasant rewards. The InspirerMundi app integrates 3 main components: monitoring (symptoms, control, adherence), gaming and social/peer support.
Participants will be able to include their action plan in the app. Within the action plan, the application can lead to changes in the medication effectively taken, which means that the therapeutic level can be adjusted according to the action plan.
Participants in the experimental arm will be able to share with their physician, through the app, their medication adherence and asthma control data in the 3 months visit, and whenever patients wish during the study period.
Usual careOther
Usual care will consist of pharmacological treatment and medical monitoring through routine medical visits.
| Study group | Role | What they receive |
|---|---|---|
| InspirerMundi app plus usual care | Experimental | Patients, in addition to usual care, will be invited to use the InspirerMundi app for 4 months to support adherence to preventive inhaled medication and their asthma self-management. Receives: Device: InspirerMundi app; Other: Usual care |
| Usual care | Active comparator | Patients in the control group will maintain usual care during the study. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control (CARAT)
Change from baseline in the proportion of patients with controlled asthma as assessed with the CARAT-Control of Allergic Rhinitis and Asthma Test at 3 months
Measured: Baseline, 3 months
Secondary outcomes (7)
Asthma control (GINA)
Change in Asthma control assessed by the physician acording to GINA (Global initiative for asthma) guidelines
Measured: Baseline, 3 months
Change in Number of asthma exacerbations in last 3 months
Worsening asthma events requiring unscheduled health care use (emergency department visit, hospitalization, and/or any medical assistance) or initiation/increase in systemic corticosteroids.
Measured: Baseline, 3 months
Change in Absenteeism in the last 3 months
Number of days absent from the workplace/school
Measured: Baseline, 3 months
Change in Treatment adherence (Test of the Adherence to Inhalers)
Assessed with Test of the Adherence to Inhalers
Measured: Baseline, 3 months
Change in Beliefs about Medicines
Assessed with specific Beliefs about Medicines Questionnaire
Measured: Baseline, 3 months
Change in Satisfaction with inhaler
Assessed through 4 visual analogue scales (VAS 0-100, higher number, higher satisfaction)
Measured: 1 week, 4 months
Change in EuroQol-5 Dimensions (EQ-5D)
Assessed with EuroQol-5 Dimensions (EQ-5D). Health state index scores generally range from less than 0 (where 0 is the value of a health state equivalent to dead) to 1 (the value of full health), with higher scores indicating higher health utility.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study startJan 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Responsible party
- Sponsor
- Investigators
- João Almeida Fonseca, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05129527
- Sponsor's protocol ID
- mINSPIRERS RCT
- Acronym
- mINSPIRERS_RCT
- Status last verified
- Dec 2022
- First submitted
- 6 Oct 2021
- Last updated
- 19 Oct 2023
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Mobile App on Improving Asthma Control in Adolescents and Adults With Persistent Asthma: A Pilot Randomized Multicentre, Superiority Clinical Trial
- ClinicalTrials.gov ID
- NCT05129527
- Acronym / sponsor ID
- mINSPIRERS_RCT / mINSPIRERS RCT
- Conditions
- Asthma
- Keywords
- mHealth, smartphone, medication adherence, self-management, technology assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Centro de Investigação em Tecnologias e Serviços de Saúde, Rede de Investigação em Saúde
- Study start
- Jan 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 22 Nov 2021 (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.
mINSPIRERS_RCT aims to assess the magnitude of the effect of a mobile app for improving asthma control in adolescents and adults with persistent asthma, followed at primary and secondary care in Portugal.
Detailed description
INSPIRERS_RCT is a pilot randomized, multicenter superiority clinical trial regarding the effect of a mobile app together with usual care (experimental group) in comparison to usual care alone (control group) in adolescents and adults with persistent asthma. The study includes two face-to-face visits (initial visit and at 3 months), and 3 telephone interviews (1 week, 1 month and 4 months), implemented in 32 primary (General Practice) and secondary care centers (Allergy, Pediatrics, Pulmonology) in Portugal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InspirerMundi app plus usual care | Experimental | Device: InspirerMundi app, Other: Usual carePatients, in addition to usual care, will be invited to use the InspirerMundi app for 4 months to support adherence to preventive inhaled medication and their asthma self-management. |
| Usual care | Active comparator | Other: Usual carePatients in the control group will maintain usual care during the study. |
Who may qualify
- Ages
- 13 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age between 13 and 17 years (adolescents) or and between 18 and 64 years (adults);
- Previous medical diagnosis of persistent asthma;
- Uncontrolled or partially controlled asthma according to Global Initiative for Asthma (GINA) criteria;
- Active prescription of inhaled control medication for asthma (all treatments will be accepted. There will be no change in the prescribed therapeutic regimen directly or indirectly related to participation in this study);
- Ability to use mobile app and a access (availability and use) to Android mobile devices with internet access;
Key exclusion criteria (2 listed)
- Patients diagnosed with chronic respiratory disease other than asthma or, diagnosed with another significant chronic disease, with possible interference with the objectives and/or evaluations of the study.
- Patients that participated in previous feasibility studies with InspirerMundi app will be excluded.
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 |
|---|---|---|
| InspirerMundi appPatients in the experimental group, in addition to usual care, will be invited to use the InspirerMundi app for 4 months to support adherence to preventive inhaled medication and their asthma self-management. The purpose of the InspirerMundi app is to transform the adherence process into a positive experience through immediate and pleasant rewards. The InspirerMundi app integrates 3 main components: monitoring (symptoms, control, adherence), gaming and social/peer support. Participants will be able to include their action plan in the app. Within the action plan, the application can lead to changes in the medication effectively taken, which means that the therapeutic level can be adjusted according to the action plan. Participants in the experimental arm will be able to share with their physician, through the app, their medication adherence and asthma control data in the 3 months visit, and whenever patients wish during the study period. | Device | InspirerMundi app plus usual care |
| Usual careUsual care will consist of pharmacological treatment and medical monitoring through routine medical visits. | Other | InspirerMundi app plus usual care, Usual care |
Primary outcome
Asthma control (CARAT)
Time frame: Baseline, 3 months
Change from baseline in the proportion of patients with controlled asthma as assessed with the CARAT-Control of Allergic Rhinitis and Asthma Test at 3 months
7 secondary outcomes
Asthma control (GINA)
Time frame: Baseline, 3 months
Change in Number of asthma exacerbations in last 3 months
Time frame: Baseline, 3 months
Change in Absenteeism in the last 3 months
Time frame: Baseline, 3 months
Change in Treatment adherence (Test of the Adherence to Inhalers)
Time frame: Baseline, 3 months
Change in Beliefs about Medicines
Time frame: Baseline, 3 months
Change in Satisfaction with inhaler
Time frame: 1 week, 4 months
Change in EuroQol-5 Dimensions (EQ-5D)
Time frame: Baseline, 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- 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.
João Almeida Fonseca, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InspirerMundi app in people with Asthma, run by Universidade do Porto at 1 site in Portugal.
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 6 inclusion and 2 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 19 Oct 2023. 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 Portugal. 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?
Contact João Almeida Fonseca, PhD ((+351) 229027242 ext. 26905, jfonseca@med.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control (CARAT) (time frame: Baseline, 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 19 Oct 2023; AzTrials last refreshed its copy on 4 Nov 2026.