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

NCT ID: NCT05129527

Last Updated: 2023-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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InspirerMundi app plus 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.

Group Type EXPERIMENTAL

InspirerMundi app

Intervention Type 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.

Usual care

Intervention Type OTHER

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

Usual care

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

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

Interventions

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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.

Intervention Type DEVICE

Usual care

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro de Investigação em Tecnologias e Serviços de Saúde

OTHER

Sponsor Role collaborator

Rede de Investigação em Saúde

OTHER

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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João Almeida Fonseca, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade do Porto

Locations

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Faculty of Medicine of the University of Porto

Porto, , Portugal

Site Status

Countries

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Portugal

Central Contacts

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João Almeida Fonseca, PhD

Role: CONTACT

(+351) 229027242 ext. 26905

Cristina Jácome, PhD

Role: CONTACT

(+351) 225513622 ext. 26924

Facility Contacts

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Cristina Jácome, PhD

Role: primary

Other Identifiers

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mINSPIRERS RCT

Identifier Type: -

Identifier Source: org_study_id

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