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Table 1 Items from the World Health Organization Trial Registration Data Set

From: Mobile application for monitoring patients under home oxygen therapy: a protocol for a randomized controlled trial

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)