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

Universidade do Porto

Status: Not yet enrolling

Conditions: Asthma

Treatments: Device: InspirerMundi app; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT05129527

mINSPIRERS RCT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 13 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

InspirerMundi app plus usual care

Experimental group

Description:

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.

Treatment:

Other: Usual care

Device: InspirerMundi app

Usual care

Active Comparator group

Description:

Patients in the control group will maintain usual care during the study.

Treatment:

Other: Usual care