An interventional study of InspirerMundi app and Usual care in Asthma, sponsored by Universidade do Porto. Status unknown at 1 site in Portugal. Open to participants aged 13 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by Universidade do Porto · Not applicable, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 124 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Universidade do Porto is the lead sponsor of 170 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: InspirerMundi app · Other: Usual care
Patients in the control group will maintain usual care during the study.
Other: Usual care
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 care will consist of pharmacological treatment and medical monitoring through routine medical visits.
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
Time frame: Baseline, 3 months
Asthma control (GINA)
Change in Asthma control assessed by the physician acording to GINA (Global initiative for asthma) guidelines
Time frame: 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.
Time frame: Baseline, 3 months
Change in Absenteeism in the last 3 months
Number of days absent from the workplace/school
Time frame: Baseline, 3 months
Change in Treatment adherence (Test of the Adherence to Inhalers)
Assessed with Test of the Adherence to Inhalers
Time frame: Baseline, 3 months
Change in Beliefs about Medicines
Assessed with specific Beliefs about Medicines Questionnaire
Time frame: Baseline, 3 months
Change in Satisfaction with inhaler
Assessed through 4 visual analogue scales (VAS 0-100, higher number, higher satisfaction)
Time frame: 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.
Time frame: Baseline, 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Universidade do Porto