Mobile Application for Monitoring Patients With Home Oxygen. A Protocol of a Randomized and Controlled Clinical Trial.

NCT04820790 | Completed

• 1 other identifier: 01
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The use of mobile technology has become part of the reality capable of changing the health services' paradigm. As a proof of that, nowadays, technology is seemed as a key tool in processes such as: data collection, epidemiological surveillance, health promotion, and disease prevention. Therefore, technological tools should be taken as an advantage to optimize the control or monitoring of patients with chronic diseases including those who require the use of home oxygen therapy. Objective: Determine the efficiency of a mobile application for clinical monitoring of patients who require home oxygen therapy. Methods A randomized-controlled clinical trial including individuals whose age is 18 years or older who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) under treatment with home oxygen therapy. The sample will be divided in two groups: the intervention group will be made up of those who are followed up with the mobile app, and the control group will be made up of the patients who are followed up conventionally (regular visit of the respiratory caregiver). To measure the effect of the intervention, some outcomes variables will be taken as the recognition of self-management of dyspnea, number of exacerbations associated with oxygen therapy, and the frequency of underutilization of oxygen supplies.

Conditions

Oxygen-therapy

Keywords

Oxygen-therapy; e-Health; Mobile applications

Outcome Measures

Primary Outcomes (2)

• Recognition of self-management of dyspnea and through the mobile app.

  The Borg scale is a visual analogue scale standardised and validated . It is quick and easy to apply, allowing a graphical evaluation of the subjective perception of respiratory distress by the same patient. It has been used since the 1970s and has a range from 0 to 10. The scale determines dyspnea intensity and has a written expression added to the number, which helps categorise dyspnea's sensation in the individual being tested. The result is recorded and encoded. The interval between the ranges of the scale increases progressively, and the number 10 shows the greatest perception of dyspnea. The maximum point indicates that the severity of the disease has increased even above 10.

  up to 12 weeks

• Saint George questionnaire for the assessment of health-related quality of life

  It consists of 50 items divided into three scales: symptoms, activity, and impact. The items on the symptom scale refer to the frequency and severity of respiratory symptoms. The items on the activity scale assess the limitation of the activities due to dyspnea. In the impact scale, the psychological and social functional disorders produced by the disease are assessed. The items are formulated in two different ways: in the form of a question with five multiple choices/answers in which just one can be selected, and in the form of a sentence with two options: yes/no. The questionnaire is preferably self-administered, although it is also accepted through a personal interview. The average completion time is 10 minutes. The score is calculated for each of the questionnaire scales, and there is also an overall score. The range of all is from 0 (without altering the quality of life) until 100 (maximum alteration of life quality).

  up to 6 weeks

Other Outcomes (1)

• Oxygen saturation

  up to 6 weeks

Study Arms (2)

Experimental Group 1

EXPERIMENTAL

The efficiency of the mobile app in the follow-up of patients with home oxygen will be evaluated during 3 months

Other: Mobile applications

Intervention Group 2:

NO INTERVENTION

Regular monitoring of the home oxygen without mobile app during 3 months

Interventions

Mobile applications OTHER

Monitoring of patients with home oxygen through a mobile application

Also known as: App

Experimental Group 1

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ToDoMed: lead

Study Sites (1)

TodoMed

Palmira, Valle del Cauca Department, 763531, Colombia

Location

Related Publications (19)

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  PMID: 23271820 RESULT

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• Rabe KF, Watz H. Chronic obstructive pulmonary disease. Lancet. 2017 May 13;389(10082):1931-1940. doi: 10.1016/S0140-6736(17)31222-9. Epub 2017 May 11.

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  PMID: 29794207 RESULT

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  PMID: 30517340 RESULT

• Oh H, Rizo C, Enkin M, Jadad A. What is eHealth (3): a systematic review of published definitions. J Med Internet Res. 2005 Feb 24;7(1):e1. doi: 10.2196/jmir.7.1.e1.

  PMID: 15829471 RESULT

• Mirkovic J, Kaufman DR, Ruland CM. Supporting cancer patients in illness management: usability evaluation of a mobile app. JMIR Mhealth Uhealth. 2014 Aug 13;2(3):e33. doi: 10.2196/mhealth.3359.

  PMID: 25119490 RESULT

• Hallensleben C, van Luenen S, Rolink E, Ossebaard HC, Chavannes NH. eHealth for people with COPD in the Netherlands: a scoping review. Int J Chron Obstruct Pulmon Dis. 2019 Jul 26;14:1681-1690. doi: 10.2147/COPD.S207187. eCollection 2019.

  PMID: 31440044 RESULT

• Gurbeta L, Badnjevic A, Maksimovic M, Omanovic-Miklicanin E, Sejdic E. A telehealth system for automated diagnosis of asthma and chronical obstructive pulmonary disease. J Am Med Inform Assoc. 2018 Sep 1;25(9):1213-1217. doi: 10.1093/jamia/ocy055.

  PMID: 29788482 RESULT

• Rassouli F, Boutellier D, Duss J, Huber S, Brutsche MH. Digitalizing multidisciplinary pulmonary rehabilitation in COPD with a smartphone application: an international observational pilot study. Int J Chron Obstruct Pulmon Dis. 2018 Nov 23;13:3831-3836. doi: 10.2147/COPD.S182880. eCollection 2018.

  PMID: 30538444 RESULT

• Bitsaki M, Koutras C, Koutras G, Leymann F, Steimle F, Wagner S, Wieland M. ChronicOnline: Implementing a mHealth solution for monitoring and early alerting in chronic obstructive pulmonary disease. Health Informatics J. 2017 Sep;23(3):197-207. doi: 10.1177/1460458216641480. Epub 2016 Apr 21.

  PMID: 27102885 RESULT

• Nguyen HQ, Donesky-Cuenco D, Wolpin S, Reinke LF, Benditt JO, Paul SM, Carrieri-Kohlman V. Randomized controlled trial of an internet-based versus face-to-face dyspnea self-management program for patients with chronic obstructive pulmonary disease: pilot study. J Med Internet Res. 2008 Apr 16;10(2):e9. doi: 10.2196/jmir.990.

  PMID: 18417444 RESULT

• Hernandez-Reyes A, Camara-Martos F, Molina Recio G, Molina-Luque R, Romero-Saldana M, Moreno Rojas R. Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Feb 12;8(2):e13747. doi: 10.2196/13747.

  PMID: 32049065 RESULT

• Yang F, Wang Y, Yang C, Hu H, Xiong Z. Mobile health applications in self-management of patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis of their efficacy. BMC Pulm Med. 2018 Sep 4;18(1):147. doi: 10.1186/s12890-018-0671-z.

  PMID: 30180835 RESULT

• Scott IA, Scuffham P, Gupta D, Harch TM, Borchi J, Richards B. Going digital: a narrative overview of the effects, quality and utility of mobile apps in chronic disease self-management. Aust Health Rev. 2020 Feb;44(1):62-82. doi: 10.1071/AH18064.

  PMID: 30419185 RESULT

• Early J, Gonzalez C, Gordon-Dseagu V, Robles-Calderon L. Use of Mobile Health (mHealth) Technologies and Interventions Among Community Health Workers Globally: A Scoping Review. Health Promot Pract. 2019 Nov;20(6):805-817. doi: 10.1177/1524839919855391. Epub 2019 Jun 10.

  PMID: 31179777 RESULT

• Naranjo-Rojas A, Perula-de Torres LA, Cruz-Mosquera FE, Molina-Recio G. Efficacy and Acceptability of a Mobile App for Monitoring the Clinical Status of Patients With Chronic Obstructive Pulmonary Disease Receiving Home Oxygen Therapy: Randomized Controlled Trial. J Med Internet Res. 2025 Jan 6;27:e65888. doi: 10.2196/65888.

  PMID: 39761550 DERIVED

• Naranjo-Rojas A, Perula-de-Torres LA, Molina-Recio G. Patients, caregivers, and healthcare professionals' needs when designing the content of a mobile application for the clinical monitoring of patients with chronic obstructive pulmonary disease and home oxygen therapy: A user-centered design. Internet Interv. 2022 Jun 10;29:100552. doi: 10.1016/j.invent.2022.100552. eCollection 2022 Sep.

  PMID: 35756891 DERIVED

• Naranjo-Rojas A, Perula-de-Torres LA, Cruz-Mosquera FE, Molina-Recio G. Mobile application for monitoring patients under home oxygen therapy: a protocol for a randomized controlled trial. BMC Fam Pract. 2021 May 26;22(1):104. doi: 10.1186/s12875-021-01450-8.

  PMID: 34039277 DERIVED

MeSH Terms

Interventions

Amyloid

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Guillermo Molina Recio, PhD

  Universidad de Córdoba - España

  STUDY DIRECTOR

• Luis A Pérula de torres, PhD

  Universidad de Córdoba - España

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Respiratory therapist - Magister

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 29, 2021
• Study Start: November 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)