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

Asthma Clinical Trial

— mINSPIRERS_RCT  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05129527
• Other study ID #: mINSPIRERS RCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: December 2022
• Source: Universidade do Porto
• Contact: João Almeida Fonseca, PhD
• Phone: (+351) 229027242
• Email: jfonseca[@]med.up.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• InspirerMundi app
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.

Other:
• Usual care
Usual care will consist of pharmacological treatment and medical monitoring through routine medical visits.

Locations

Country	Name	City	State
Portugal	Faculty of Medicine of the University of Porto	Porto

Sponsors (4)

Lead Sponsor	Collaborator
Universidade do Porto	Centro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS), Faculty of Medicine (FMUP), Rede de Investigação em Saúde (RISE), Laboratório Associado

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 3 months
Secondary	Asthma control (GINA)	Change in Asthma control assessed by the physician acording to GINA (Global initiative for asthma) guidelines	Baseline, 3 months
Secondary	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.	Baseline, 3 months
Secondary	Change in Absenteeism in the last 3 months	Number of days absent from the workplace/school	Baseline, 3 months
Secondary	Change in Treatment adherence (Test of the Adherence to Inhalers)	Assessed with Test of the Adherence to Inhalers	Baseline, 3 months
Secondary	Change in Beliefs about Medicines	Assessed with specific Beliefs about Medicines Questionnaire	Baseline, 3 months
Secondary	Change in Satisfaction with inhaler	Assessed through 4 visual analogue scales (VAS 0-100, higher number, higher satisfaction)	1 week, 4 months
Secondary	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.	Baseline, 3 months