Table 1.

Items from the World Health Organization Trial Registration Data Set

Data category	Information
Primary registry and trial identifying number	ClinicalTrials.gov NCT04820790
Date of registration in primary registry	March 29, 2021
Secondary identifying numbers	Not Applicable
Source(s) of monetary or material support	Todomed
Primary sponsor	Todomed
Secondary sponsor(s)	Not applicable
Contact for public queries	Anisbed Naranjo Rojas, magister, + 573006658955anisbednaranjo24@gmail.com
Contact for scientific queries	TodoMed, Colombia
Public title	Mobile Application for Monitoring Patients with Home Oxygen. A Protocol of a Randomized and Controlled Clinical Trial
Scientific title	Mobile Application for Monitoring Patients with Home Oxygen. A Protocol of a Randomized and Controlled Clinical Trial
Countries of recruitment	Colombia
Health condition(s) or problem(s) studied	Oxygen-therapy
Intervention(s)	Experimental: Experimental Group 1 The efficiency of the mobile app in the follow-up of patients with home oxygen will be evaluated during 6 months No Intervention: Intervention Group 2: Regular monitoring of the home oxygen without mobile app during 6 months
Key inclusion and exclusion criteria	Inclusion Criteria: Individuals of 18 years of age and older Patient with PaO2 < 60 mmHg, SO2 < 89% and dyspnea. Patients with home oxygen therapy enrolled in-home care programs during the study period. Time of evolution of the disease greater to one year Patients who express their willingness to participate in the study through their informed consent. Exclusion Criteria: Patients with the following exceptional situations will be excluded from the study: Patients with invasive and/or non-invasive mechanical ventilation Patients with the inability to operate a mobile application or those who do not have a smartphone with an operating system (Android or iOS) and available data connection.
Study type	Interventional (Clinical Trial), Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Supportive Care
Date of first enrolment	June 1, 2021
Target sample size	44
Recruitment status	Not yet recruiting
Primary outcome(s)	Recognition of self-management of dyspnea and through the mobile app (Time Frame: up to 12 weeks for 6 months)
Key secondary outcomes	Saint George questionnaire for the assessment of health-related quality of life (Time Frame: up to 6 weeks for 6 months)