Effect of Remote Vital Signs Monitoring in People Receiving Long-Term Oxygen Therapy: Protocol for a Randomized Controlled Trial

Background Individuals receiving long-term oxygen therapy (LTOT) are often confined to their homes and have impaired health-related quality of life (HRQoL). Despite technological advances, monitoring these individuals remains a challenge. Objective This study aims to evaluate the impact of remote monitoring on HRQoL, dyspnea, health status, symptoms of anxiety and depression, and adherence to data entry via a mobile app in individuals receiving LTOT. Methods This randomized controlled trial will recruit 60 participants, including clinically stable adults diagnosed with chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) who use LTOT. Participants will be randomized in a 1:1 ratio to either the control group (CG) or the intervention group (IG), stratified by diagnosis (COPD or ILD), and will be followed for 90 days. All participants will use a mobile app that serves as the central platform for remote monitoring. The app enables daily recording of physiological data, including heart rate (HR), peripheral oxygen saturation (SpO2), and oxygen flow rate. In addition, validated questionnaires (EQ-5D-5L, modified Medical Research Council [mMRC] Dyspnea Scale, Hospital Anxiety and Depression Scale [HADS], and COPD Assessment Test [CAT] or the King Brief Interstitial Lung Disease [K-BILD] questionnaire, depending on diagnosis) will be self-administered through the app at predefined time points. The CG will receive monthly telephone follow-up (every 30 days), while the IG will receive biweekly telephone follow-up (every 15 days). During these structured calls, trained health care professionals will collect clinical information and ensure data completeness. In addition, participants in the IG will use a wearable smartwatch that enables continuous physiological monitoring (HR and SpO2), with data transmitted to a secure platform and analyzed weekly using an AI-assisted system to support adherence monitoring and identify physiological patterns. Participants in the IG may receive additional contact if clinically relevant abnormalities or reduced adherence are detected. Outcomes will be interpreted according to the minimal clinically important difference (MCID) for dyspnea (mMRC Dyspnea Scale), health status (CAT or K-BILD), quality of life (EQ-5D-5L), and psychological symptoms (HADS). Results Funding and ethics approval were obtained in April 2023. Recruitment began in January 2024 and was completed in May 2026. A total of 62 participants were randomized, of whom 60 initiated follow-up and were included in the longitudinal analysis. Overall, 49 participants completed the 90-day follow-up. Data collection has been completed, and data analysis is ongoing. The results are expected to be submitted for publication in the first half of 2027. Conclusions This study will provide relevant evidence on the effect of remote monitoring in individuals receiving LTOT on HRQoL, dyspnea, health status, anxiety and depression, and engagement with data entry through a mobile app. Trial Registration ClinicalTrials.gov NCT06882265; https://clinicaltrials.gov/study/NCT06882265