Study protocol for testing a mobile app designed to improve health literacy and self-management in people with...

Patients with bronchiectasis unrelated to cystic fibrosis (CF) present variability in daily symptoms. Recurrent episodes of worsening symptoms can have a negative impact on lung function and quality of life, as well as increasing costs and mortality. Daily symptom monitoring can improve patients' awareness of variations and support self-management. Mobile applications for tracking symptoms may encourage engagement, enabling problems to be identified early and potentially reducing exacerbations.

This manuscript describes the protocol for a randomised controlled trial designed to evaluate a digital symptom-monitoring tool (ANIMA) for patients with bronchiectasis unrelated to CF patients. Eligible participants will be randomised by sealed, opaque envelopes to intervention (GR-A) or control (GR-C). Both groups will complete the Bronchiectasis Health Questionnaire (BHQ), Health Literacy Questionnaire (HLQ-BR); socioeconomic status will be assessed using a validated instrument. All will receive an educational leaflet. GR-A will use the ANIMA application for daily symptom monitoring, and a GR-C, which will continue with their usual healthcare follow-up without using the application. All participants will be followed for a period of 6 months. At the end of the 6 month follow-up, the baseline questionnaires (BHQ and HLQ-BR) will be reapplied in both groups, and the Telehealth Usability Questionnaire - Brazilian version will be administered exclusively to participants in the GR-A. The planned sample size is 86 participants (43 per group), with a minimum feasible recruitment target of 60 participants due to the limited eligible population and the fixed recruitment window. Data will be analysed using SPSS Statistics version 25 (IBM Corp., Armonk, NY, USA). Descriptive statistics will summarise baseline characteristics. Between-group comparisons will be performed with appropriate parametric or non-parametric tests according to data distribution. Primary analysis will follow the intention-to-treat principle, with a complementary per-protocol analysis considering participants completing at least 50% of planned assessments. Statistical significance will be set at p<0.05. Recruitment began in April 2025 and will continue until October 2025, with follow-up completion in April 2026.

Approved by the Research Ethics Committee of the State University of Campinas (CAAE: 48830621.2.0000.5404). Results will be disseminated via peer-reviewed publications and conference presentations.

Brazilian Clinical Trials Registry (ReBEC) - U1111-1313-6511. Registered prior to recruitment start.

V.1.0 - August 2025.