Effect of a Mobile App on Improving Asthma Control in Patients With Persistent Asthma

Not Applicable

Not yet recruiting

• Conditions: Asthma
• Interventions: Device: InspirerMundi app; Other: Usual care

• Registration Number: NCT05129527
• Lead Sponsor: Universidade do Porto

Brief 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.

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 Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-22
• Status Verified: 2022-12
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Study Start: 2024-01
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
InspirerMundi app plus usual care	Usual care	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.
InspirerMundi app plus usual care	InspirerMundi app	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.
Usual care	Usual care	Patients in the control group will maintain usual care during the study.

Primary Outcome Measures

Name	Time	Method
Asthma control (CARAT)	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

Secondary Outcome Measures

Name	Time	Method
Asthma control (GINA)	Baseline, 3 months	Change in Asthma control assessed by the physician acording to GINA (Global initiative for asthma) guidelines
Change in Absenteeism in the last 3 months	Baseline, 3 months	Number of days absent from the workplace/school
Change in Treatment adherence (Test of the Adherence to Inhalers)	Baseline, 3 months	Assessed with Test of the Adherence to Inhalers
Change in EuroQol-5 Dimensions (EQ-5D)	Baseline, 3 months	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.
Change in Number of asthma exacerbations in last 3 months	Baseline, 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.
Change in Beliefs about Medicines	Baseline, 3 months	Assessed with specific Beliefs about Medicines Questionnaire
Change in Satisfaction with inhaler	1 week, 4 months	Assessed through 4 visual analogue scales (VAS 0-100, higher number, higher satisfaction)

Trial Locations

Locations (1)

Faculty of Medicine of the University of Porto; 🇵🇹 Porto, Portugal