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| Name | Class |
|---|---|
| Centro de Investigação em Tecnologias e Serviços de Saúde | OTHER |
| Rede de Investigação em Saúde | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual care | Active Comparator | Patients in the control group will maintain usual care during the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control (GINA) | Change in Asthma control assessed by the physician acording to GINA (Global initiative for asthma) guidelines | Baseline, 3 months |
| Change in Number of asthma exacerbations in last 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| João Almeida Fonseca, PhD | Contact | (+351) 229027242 | 26905 | jfonseca@med.up.pt |
| Cristina Jácome, PhD | Contact | (+351) 225513622 | 26924 | cjacome@med.up.pt |
| Name | Affiliation | Role |
|---|---|---|
| João Almeida Fonseca, PhD | Universidade do Porto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine of the University of Porto | Porto | 4200-319 | Portugal |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Usual care | Other | Usual care will consist of pharmacological treatment and medical monitoring through routine medical visits. |
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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 |
| Change in Absenteeism in the last 3 months | Number of days absent from the workplace/school | Baseline, 3 months |
| Change in Treatment adherence (Test of the Adherence to Inhalers) | Assessed with Test of the Adherence to Inhalers | Baseline, 3 months |
| Change in Beliefs about Medicines | Assessed with specific Beliefs about Medicines Questionnaire | Baseline, 3 months |
| Change in Satisfaction with inhaler | Assessed through 4 visual analogue scales (VAS 0-100, higher number, higher satisfaction) | 1 week, 4 months |
| 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 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |