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) |