Clinical trial NCT05129527: Effect of a Mobile App on Improving Asthma Control in Patients With Persistent Asthma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: mHealth
smartphone
medication adherence
self-management
technology assessment
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Centro de Investigação em Tecnologias e Serviços de Saúde
name: Rede de Investigação em Saúde
First posted: 2021-11-22
Enrollment: 124
Sex: ALL
Minimum age (years): 13
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma control (CARAT)
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Asthma control (GINA)
timeFrame: Baseline, 3 months
measure: Change in Number of asthma exacerbations in last 3 months
timeFrame: Baseline, 3 months
measure: Change in Absenteeism in the last 3 months
timeFrame: Baseline, 3 months
measure: Change in Treatment adherence (Test of the Adherence to Inhalers)
timeFrame: Baseline, 3 months
measure: Change in Beliefs about Medicines
timeFrame: Baseline, 3 months
measure: Change in Satisfaction with inhaler
timeFrame: 1 week, 4 months
measure: Change in EuroQol-5 Dimensions (EQ-5D)
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Faculty of Medicine of the University of Porto
Study officials:
affiliation: Universidade do Porto
name: João Almeida Fonseca, PhD
role: PRINCIPAL_INVESTIGATOR
References: