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Accepted for/Published in: JMIR Research Protocols

Date Submitted: Feb 11, 2026
Open Peer Review Period: Feb 11, 2026 - Apr 8, 2026
Date Accepted: May 27, 2026
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

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

Reis ERMd, Alencar GM, Schneider AM, Fernandes MCT, dos Santos JdMB, de Caravlho CRF

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

JMIR Res Protoc 2026;15:e93352

DOI: 10.2196/93352

PMID: 42628026

Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.

Effect of remote monitoring in people using long-term oxygen therapy: an RCT protocol

  • Elinny Raissa Moreira dos Reis; 
  • Gabriela Martins Alencar; 
  • Amanda Maria Schneider; 
  • Mari ClausseFernanden Tani Fernandes; 
  • Juliana de Melo Batista dos Santos; 
  • Celso Ricardo Fernandes de Caravlho

ABSTRACT

Background:

Individuals receiving Long-Term Oxygen Therapy (LTOT) usually stay restricted at home and have impaired health-related quality of life (HRQoL). Despite technological advances, there is no proper monitoring for these individuals.

Objective:

To evaluate the impact of remote monitoring on HRQoL, dyspnea, and anxiety and depression symptoms in people undergoing LTOT

Methods:

This randomized controlled trial will include clinically stable adults who use long-term oxygen therapy (LTOT). Participants will be randomized to either a control (CG) or an intervention group (IG) and will be followed for 90 days. Both CG and IG will receive a pulse oximeter and a mobile application to manually record vital signs, including heart rate (HR), oxygen saturation (SpO₂), and oxygen flow. The IG will also receive a smartwatch that continuously monitors HR and SpO₂. Data from the device will be monitored online by a healthcare professional and will also be analyzed by artificial intelligence (AI) to track adherence and vital sign patterns. At baseline, health-related quality of life (HRQoL), will be assessed using the EQ-5D-5L, and symptoms of anxiety and depression will be assessed using the HADS with reassessments every 30 days. Additionally, dyspnea, assessed by the mMRC, and health status, assessed using the King's Brief Interstitial Lung Disease (KBILD) and COPD Assessment Test (CAT), will be evaluated every 15 days. The IG will be contacted by phone if low adherence or abnormal vital sign patterns are observed.

Results:

Data will be analyzed considering the minimal clinically important difference (MCID) for outcomes including dyspnea (mMRC), health status (KBILD or CAT), quality of life (EQ-5D-5L), and symptoms of anxiety and depression (HADS).

Conclusions:

If successful, this study will demonstrate that individuals receiving long-term home oxygen therapy combined with remote monitoring intervention, will experience improved quality of life. Data collection is currently ongoing and is expected to continue until 2026, with publication of the results. Clinical Trial: (NCT06882265)


 Citation

Please cite as:

Reis ERMd, Alencar GM, Schneider AM, Fernandes MCT, dos Santos JdMB, de Caravlho CRF

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

JMIR Res Protoc 2026;15:e93352

DOI: 10.2196/93352

PMID: 42628026

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