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

NCT05129527 | Unknown

• 1 other identifier: mINSPIRERS RCT
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

mHealth; smartphone; medication adherence; self-management; technology assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Asthma control (GINA)

  Baseline, 3 months

• Change in Number of asthma exacerbations in last 3 months

  Baseline, 3 months

• Change in Absenteeism in the last 3 months

  Baseline, 3 months

• Change in Treatment adherence (Test of the Adherence to Inhalers)

  Baseline, 3 months

• Change in Beliefs about Medicines

  Baseline, 3 months

Study Arms (2)

InspirerMundi app plus usual care

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

InspirerMundi app DEVICE

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.

InspirerMundi app plus usual care

Usual care OTHER

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

InspirerMundi app plus usual care; Usual care

Eligibility Criteria

• Age: 13 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro de Investigação em Tecnologias e Serviços de Saúde: collaborator
• Rede de Investigação em Saúde: collaborator

Study Sites (1)

Faculty of Medicine of the University of Porto

Porto, 4200-319, Portugal

Location

MeSH Terms

Conditions

Asthma; Medication Adherence

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• João Almeida Fonseca, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

João Almeida Fonseca, PhD

CONTACT

(+351) 229027242; jfonseca@med.up.pt

Cristina Jácome, PhD

CONTACT

(+351) 225513622; cjacome@med.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 22, 2021
• Study Start: January 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 19, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)