Oxygen-therapyNCT04820790
Mobile Application for Monitoring Patients With Home Oxygen. A Protocol of a Randomized and Controlled Clinical Trial.
A study testing Mobile applications in people with Oxygen-therapy, run by ToDoMed at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Oxygen-therapy
- What is being tested?
- Mobile applications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteColombia
- Study dates
- 1 Nov 2023to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
The Continuous Home Oxygen-therapy (abbreviated as OCD in Spanish) refers to the supply of oxygen for continuous, general, and/or indefinite use at the home of patients with chronic hypoxemia. The purpose of this treatment is to prolong the life of the hypoxemic patient, improve exercise tolerance, and control clinical deterioration due to low oxygen saturation.
Contextualizing the use of home oxygen in Colombia, it was observed that there was an increase in the prevalence of COPD (Chronic Obstructive Pulmonary Disease) as well as the prescription of home oxygen in the first phases of the treatment. It was found that 3.176 patients were enrolled in the home care program without knowing their sociodemographic and epidemiological characteristics. The reason behind is that there are few epidemiological studies that refer to this therapy. However, Gonzales M. et al. emphasize that current indications should be reviewed and research carried out in order to determine guidelines for recommending home oxygen in patients with COPD.
Methods / Design Study Design A randomized controlled clinical trial divided in two parallel groups with a 3-months duration will be performed in order to evaluate the efficiency of a mobile application used for the monitoring of patients with home oxygen. The control group will be made up of individuals with oxygen therapy undergoing regular monitoring (periodic visits by the respiratory caregiver), and the intervention group formed by those who have conventional monitoring with the use of the mobile app called AppO2.
Sample's size calculation A total of 32 individuals (16 for the experimental group and 16 for the control one) would be necessary to recruit, for a 1:1 ratio, a power of 80% (beta error = 20%), a certainty of 95% (alpha error = 5%) and assuming that the intervention in the experimental group will cause a 3% increase with a ±6 standard deviation in recognition of self-management of dyspnea. A final size of 44 individuals has been established (22 for the EG and 22 for the CG) to minimise the effect of possible losses in statistical power.
Intervention:
The control group comprises patients who will be under the conventional follow-up of clinical assessment and control of home oxygen supplies. The intervention group will be monitored conventionally, and they will additionally have a mobile app, "AppO2". We will follow a consecutive sampling. Patients will be recruit as on the go. The allocation will be randomly performed using a statistical software called EPIDAT, 3.1.
Study variables
The following results variables and independent variables are suggested to achieve the proposed objectives:
Variables:
- Oxygen saturation through a pulse oximeter, capillary filling, respiratory rate, heart rate, duration time of the oxygen cylinder.
- Oxygen saturation and inspired fraction of oxygen relationship
- Borg dyspnea scale
- Oxygen saturation and inspired fraction of oxygen relationship
- Recognition of self-management of dyspnea and quality of life through the mobile app.
- Saint George questionnaire for the assessment of health-related (CVRS) quality of life Statistical analysis A descriptive analysis of the variables under study will be carried out by characterising the patients. Also, graphs and frequency tables will be constructed for the qualitative variables, and the calculation of central tendency measures (mean), dispersion (standard deviation), and position (limits of the distribution and range) for the quantitative variables.
For the bivariate analysis, the Student's T-test will be performed to compare two means, while for the qualitative variables, the chi-square test and Fisher's exact test will be used. For the analysis of three or more means, the repeated measures analysis of variance (ANOVA) will be calculated. Multiple linear regressions will be used to adjust the App use's impact and eliminate confounding factors. The standardized beta coefficients, the adjusted coefficient of determination, the residuals, etc., will be calculated. An alpha error <5% will be accepted for all statistical analyses, and confidence intervals will be calculated for 95% confidence (95% CI). For the complete statistical analysis, SPSS Statistics software, version 25.0 (IBM Corp), will be used.
Practical applicability The general objective of this protocol is to evaluate the efficiency of a mobile application in the follow-up of patients with home oxygen therapy through an intervention aimed at reducing exacerbations. Besides, an attempt will be made to identify the adequacy of the prescription of oxygen systems and establish the underutilisation of oxygen supplies at home. A two-group randomized clinical follow-up will be used to evaluate the intervention.
- Conditions
- Oxygen-therapy
- Being tested
- Mobile applications
- Keywords
- Oxygen-therapy, e-Health, Mobile applications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile applicationsOther
Also called App
Monitoring of patients with home oxygen through a mobile application
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Mobile applications |
| Intervention Group 2: | No intervention | Regular monitoring of the home oxygen without mobile app during 3 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start1 Nov 2023
- Primary completion31 Mar 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Oxygen-therapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- ToDoMed
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anisbed Naranjo Rojas, ToDoMed
- Investigators
- Guillermo Molina Recio, PhD, Study director, Universidad de Córdoba - EspañaLuis A Pérula de torres, PhD, Study director, Universidad de Córdoba - España
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820790
- Sponsor's protocol ID
- 01
- Status last verified
- Aug 2024
- First submitted
- 20 Mar 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McCoy RW. Options for home oxygen therapy equipment: storage and metering of oxygen in the home. Respir Care. 2013 Jan;58(1):65-85. doi: 10.4187/respcare.01932.
PubMed 23271820Bott J, Blumenthal S, Buxton M, Ellum S, Falconer C, Garrod R, Harvey A, Hughes T, Lincoln M, Mikelsons C, Potter C, Pryor J, Rimington L, Sinfield F, Thompson C, Vaughn P, White J; British Thoracic Society Physiotherapy Guideline Development Group. Guidelines for the physiotherapy management of the adult, medical, spontaneously breathing patient. Thorax. 2009 May;64 Suppl 1:i1-51. doi: 10.1136/thx.2008.110726. No abstract available.
PubMed 19406863Rabe 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.
PubMed 28513453Branson RD. Oxygen Therapy in COPD. Respir Care. 2018 Jun;63(6):734-748. doi: 10.4187/respcare.06312.
PubMed 29794207Mesquita CB, Knaut C, Caram LMO, Ferrari R, Bazan SGZ, Godoy I, Tanni SE. Impact of adherence to long-term oxygen therapy on patients with COPD and exertional hypoxemia followed for one year. J Bras Pneumol. 2018 Sep-Oct;44(5):390-397. doi: 10.1590/S1806-37562017000000019.
PubMed 30517340Oh 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.
PubMed 15829471Mirkovic 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.
PubMed 25119490Hallensleben 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.
PubMed 31440044Gurbeta 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.
PubMed 29788482Rassouli 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.
PubMed 30538444Bitsaki 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.
PubMed 27102885Nguyen 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.
PubMed 18417444Hernandez-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.
PubMed 32049065Yang 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.
PubMed 30180835Scott 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.
PubMed 30419185
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application for Monitoring Patients With Home Oxygen. A Protocol of a Randomized and Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04820790
- Acronym / sponsor ID
- 01
- Conditions
- Oxygen-therapy
- Keywords
- Oxygen-therapy, e-Health, Mobile applications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- ToDoMedUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Continuous Home Oxygen-therapy (abbreviated as OCD in Spanish) refers to the supply of oxygen for continuous, general, and/or indefinite use at the home of patients with chronic hypoxemia. The purpose of this treatment is to prolong the life of the hypoxemic patient, improve exercise tolerance, and control clinical deterioration due to low oxygen saturation.
Contextualizing the use of home oxygen in Colombia, it was observed that there was an increase in the prevalence of COPD (Chronic Obstructive Pulmonary Disease) as well as the prescription of home oxygen in the first phases of the treatment. It was found that 3.176 patients were enrolled in the home care program without knowing their sociodemographic and epidemiological characteristics. The reason behind is that there are few epidemiological studies that refer to this therapy. However, Gonzales M. et al. emphasize that current indications should be reviewed and research carried out in order to determine guidelines for recommending home oxygen in patients with COPD.
Methods / Design Study Design A randomized controlled clinical trial divided in two parallel groups with a 3-months duration will be performed in order to evaluate the efficiency of a mobile application used for the monitoring of patients with home oxygen. The control group will be made up of individuals with oxygen therapy undergoing regular monitoring (periodic visits by the respiratory caregiver), and the intervention group formed by those who have conventional monitoring with the use of the mobile app called AppO2.
Sample's size calculation A total of 32 individuals (16 for the experimental group and 16 for the control one) would be necessary to recruit, for a 1:1 ratio, a power of 80% (beta error = 20%), a certainty of 95% (alpha error = 5%) and assuming that the intervention in the experimental group will cause a 3% increase with a ±6 standard deviation in recognition of self-management of dyspnea. A final size of 44 individuals has been established (22 for the EG and 22 for the CG) to minimise the effect of possible losses in statistical power.
Intervention:
The control group comprises patients who will be under the conventional follow-up of clinical assessment and control of home oxygen supplies. The intervention group will be monitored conventionally, and they will additionally have a mobile app, "AppO2". We will follow a consecutive sampling. Patients will be recruit as on the go. The allocation will be randomly performed using a statistical software called EPIDAT, 3.1.
Study variables
The following results variables and independent variables are suggested to achieve the proposed objectives:
Variables:
- Oxygen saturation through a pulse oximeter, capillary filling, respiratory rate, heart rate, duration time of the oxygen cylinder.
- Oxygen saturation and inspired fraction of oxygen relationship
- Borg dyspnea scale
- Oxygen saturation and inspired fraction of oxygen relationship
- Recognition of self-management of dyspnea and quality of life through the mobile app.
- Saint George questionnaire for the assessment of health-related (CVRS) quality of life Statistical analysis A descriptive analysis of the variables under study will be carried out by characterising the patients. Also, graphs and frequency tables will be constructed for the qualitative variables, and the calculation of central tendency measures (mean), dispersion (standard deviation), and position (limits of the distribution and range) for the quantitative variables.
For the bivariate analysis, the Student's T-test will be performed to compare two means, while for the qualitative variables, the chi-square test and Fisher's exact test will be used. For the analysis of three or more means, the repeated measures analysis of variance (ANOVA) will be calculated. Multiple linear regressions will be used to adjust the App use's impact and eliminate confounding factors. The standardized beta coefficients, the adjusted coefficient of determination, the residuals, etc., will be calculated. An alpha error <5% will be accepted for all statistical analyses, and confidence intervals will be calculated for 95% confidence (95% CI). For the complete statistical analysis, SPSS Statistics software, version 25.0 (IBM Corp), will be used.
Practical applicability The general objective of this protocol is to evaluate the efficiency of a mobile application in the follow-up of patients with home oxygen therapy through an intervention aimed at reducing exacerbations. Besides, an attempt will be made to identify the adequacy of the prescription of oxygen systems and establish the underutilisation of oxygen supplies at home. A two-group randomized clinical follow-up will be used to evaluate the intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1 | Experimental | Other: Mobile applicationsThe efficiency of the mobile app in the follow-up of patients with home oxygen will be evaluated during 3 months |
| Intervention Group 2: | No intervention | –Regular monitoring of the home oxygen without mobile app during 3 months |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile applicationsAlso: AppMonitoring of patients with home oxygen through a mobile application | Other | Experimental Group 1 |
Primary outcome
Recognition of self-management of dyspnea and through the mobile app.
Time frame: up to 12 weeks
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.
Saint George questionnaire for the assessment of health-related quality of life
Time frame: up to 6 weeks
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Results publication: PubMed 23271820McCoy RW. Options for home oxygen therapy equipment: storage and metering of oxygen in the home. Respir Care. 2013 Jan;58(1):65-85. doi: 10.4187/respcare.01932.
- Results publication: PubMed 19406863Bott J, Blumenthal S, Buxton M, Ellum S, Falconer C, Garrod R, Harvey A, Hughes T, Lincoln M, Mikelsons C, Potter C, Pryor J, Rimington L, Sinfield F, Thompson C, Vaughn P, White J; British Thoracic Society Physiotherapy Guideline Development Group. Guidelines for the physiotherapy management of the adult, medical, spontaneously breathing patient. Thorax. 2009 May;64 Suppl 1:i1-51. doi: 10.1136/thx.2008.110726. No abstract available.
- Results publication: PubMed 28513453Rabe 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.
- Results publication: PubMed 29794207Branson RD. Oxygen Therapy in COPD. Respir Care. 2018 Jun;63(6):734-748. doi: 10.4187/respcare.06312.
- Results publication: PubMed 30517340Mesquita CB, Knaut C, Caram LMO, Ferrari R, Bazan SGZ, Godoy I, Tanni SE. Impact of adherence to long-term oxygen therapy on patients with COPD and exertional hypoxemia followed for one year. J Bras Pneumol. 2018 Sep-Oct;44(5):390-397. doi: 10.1590/S1806-37562017000000019.
- Results publication: PubMed 15829471Oh 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.
- Results publication: PubMed 25119490Mirkovic 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.
- Results publication: PubMed 31440044Hallensleben 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.
- Results publication: PubMed 29788482Gurbeta 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.
- Results publication: PubMed 30538444Rassouli 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.
- Results publication: PubMed 27102885Bitsaki 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.
- Results publication: PubMed 18417444Nguyen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillermo Molina Recio, PhD study director
Universidad de Córdoba - España
Luis A Pérula de torres, PhD study director
Universidad de Córdoba - España
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile applications in people with Oxygen-therapy, run by ToDoMed at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recognition of self-management of dyspnea and through the mobile app. (time frame: up to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04820790, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.