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

Primary Purpose

Asthma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
InspirerMundi app
Usual care
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring mHealth, smartphone, medication adherence, self-management, technology assessment

Eligibility Criteria

13 Years - 64 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Faculty of Medicine of the University of Porto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

InspirerMundi app plus usual care

Usual care

Arm 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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 6, 2021
Last Updated
October 18, 2023
Sponsor
Universidade do Porto
Collaborators
Faculty of Medicine (FMUP), Centro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS), Rede de Investigação em Saúde (RISE), Laboratório Associado
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1. Study Identification

Unique Protocol Identification Number
NCT05129527
Brief Title
Effect of a Mobile App on Improving Asthma Control in Patients With Persistent Asthma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Porto
Collaborators
Faculty of Medicine (FMUP), Centro de Investigação em Tecnologias e Serviços de Saúde (CINTESIS), Rede de Investigação em Saúde (RISE), Laboratório Associado

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
mHealth, smartphone, medication adherence, self-management, technology assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
InspirerMundi app plus usual care
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Patients in the control group will maintain usual care during the study.
Intervention Type
Device
Intervention Name(s)
InspirerMundi app
Intervention Description
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
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care will consist of pharmacological treatment and medical monitoring through routine medical visits.
Primary Outcome Measure Information:
Title
Asthma control (CARAT)
Description
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
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Asthma control (GINA)
Description
Change in Asthma control assessed by the physician acording to GINA (Global initiative for asthma) guidelines
Time Frame
Baseline, 3 months
Title
Change in Number of asthma exacerbations in last 3 months
Description
Worsening asthma events requiring unscheduled health care use (emergency department visit, hospitalization, and/or any medical assistance) or initiation/increase in systemic corticosteroids.
Time Frame
Baseline, 3 months
Title
Change in Absenteeism in the last 3 months
Description
Number of days absent from the workplace/school
Time Frame
Baseline, 3 months
Title
Change in Treatment adherence (Test of the Adherence to Inhalers)
Description
Assessed with Test of the Adherence to Inhalers
Time Frame
Baseline, 3 months
Title
Change in Beliefs about Medicines
Description
Assessed with specific Beliefs about Medicines Questionnaire
Time Frame
Baseline, 3 months
Title
Change in Satisfaction with inhaler
Description
Assessed through 4 visual analogue scales (VAS 0-100, higher number, higher satisfaction)
Time Frame
1 week, 4 months
Title
Change in EuroQol-5 Dimensions (EQ-5D)
Description
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.
Time Frame
Baseline, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
João Almeida Fonseca, PhD
Phone
(+351) 229027242
Ext
26905
Email
jfonseca@med.up.pt
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Jácome, PhD
Phone
(+351) 225513622
Ext
26924
Email
cjacome@med.up.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Almeida Fonseca, PhD
Organizational Affiliation
Universidade do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine of the University of Porto
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Jácome, PhD
Email
cjacome@med.up.pt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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