An interventional study of ReHub in COPD, sponsored by Bio-Sensing Solutions S.L. (DyCare). Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-03.
Sponsored by Bio-Sensing Solutions S.L. (DyCare) · Not applicable, Interventional, and Supportive care
Chronic Obstructive Pulmonary Disease (COPD), characterized by persistent airflow limitation in the respiratory airways, is a chronic condition that affects millions of people worldwide. ReHub enables healthcare professionals to design therapeutic exercise programs for the treatment of COPD patients, as well as to analyze and monitor patient rehabilitation through the information and feedback provided via the platform. The main objective of the study is to evaluate the satisfaction and usability of the ReHub platform (for respiratory rehabilitation) among COPD patients and healthcare professionals. This is a single-center satisfaction and usability study on the usage and experience of the ReHub platform (for respiratory rehabilitation).
Chronic Obstructive Pulmonary Disease (COPD), characterized by persistent airflow limitation in the respiratory airways, is a chronic condition that affects millions of people worldwide. According to various studies, COPD is one of the leading causes of morbidity and mortality in Spain and the third leading cause of death globally. Research conducted in Spain on a representative sample of the population indicates that the overall prevalence of COPD in Spain is approximately 10.2% among adults aged 40 and older. However, significant regional differences are observed, with higher rates in the northern and northeastern regions of the country.
ReHub allows healthcare professionals to design therapeutic exercise programs for the treatment of COPD patients and to analyze and monitor patient rehabilitation through the information and feedback provided via the platform.
The main objective of the study is to assess the satisfaction and usability of the ReHub platform (for respiratory rehabilitation) among COPD patients and healthcare professionals.
Methology:
Single-center satisfaction and usability study on the usage and experience of the ReHub platform (for respiratory rehabilitation). Additionally, changes in clinical parameters and functional status will be evaluated at the end of the study compared to the baseline situation (pre-post intervention study without a control group).
Recruitment will take place at the Respiratory Rehabilitation Service of Hospital Sant Pau (Barcelona-Spain). A consecutive sampling of patients who meet the inclusion criteria will be conducted during the recruitment period or until the sample size of 100 participants is reached. Participants who meet the inclusion criteria and none of the exclusion criteria will be invited to participate in the study. Once their acceptance to participate is obtained, they will be included in the study and will receive training on how to use the ReHub platform.
After using the platform for a minimum of 4 months, a survey will be administered to the patients to assess their satisfaction and usability. Additionally, changes in clinical parameters and the functional status of the patients will be assessed at the end of the study compared to the baseline situation.
Bio-Sensing Solutions S.L. (DyCare) is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
ReHub is a medical device designed to assist rehabilitation professionals by providing information for the design, monitoring, and analysis of therapeutic exercise programs for respiratory functional rehabilitation. Patients use the platform to follow the exercise program designed by their therapist from the location that suits them best.
Device: ReHub
ReHub provides support to rehabilitation professionals by offering information for the design, monitoring, and analysis of therapeutic exercise programs for respiratory functional rehabilitation.
System Usability Scale (SUS)
User satisfaction and experience (Spanish version), from 0 to 100; higher score means a better outcome
Time frame: 4 months
Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications (pSUAPP-S) for Patients
Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications for patients, from 0 to 100; higher score means a better outcome
Time frame: 4 months
Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications (pSUAPP-S) for Healthcare Professionals
Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications for Healthcare professionals, from 0 to 100; higher score means a better outcome
Time frame: 4 months
Walking test_dysnea
Dyspnea level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)
Time frame: Baseline and 4 months
Walking test_fatigue
Fatigue level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)
Time frame: Baseline and 4 months
Walking test_oxygen
SaO2 (oxygen saturation) (pre and post) in percent
Time frame: Baseline and 4 months
Walking test_ heart rate
Heart rate (pre and post) in beats per minute (bpm)
Time frame: Baseline and 4 months
Walking test_distance
Distance walked in meters
Time frame: Baseline and 4 months
Walking test_stops
Number of stops (integer number)
Time frame: Baseline and 4 months
Walking test_stops duration
Stops duration in minutes
Time frame: Baseline and 4 months
Adverse events during exercise
Adverse events during exercise: dyspnea (shortness of breath)
Time frame: During the exercises
Adherence to the platform_frequency
Compliance with the rehabilitation program in terms of frequency of use (number of days connected to the platform)
Time frame: 4 months
Adherence to the platform_compliance
Compliance with the rehabilitation program in terms of percent of performed exercices versus prescribed exercices
Time frame: 4 months
Adherence to the platform_connection time
Compliance with the rehabilitation program in terms of connection time (in minutes)
Time frame: 4 months
Interaction between the physiotherapist and the patient
Number of messages exchanged between the patient and the physiotherapist through ReHub platform
Time frame: During the follow-up until 4 months
Chronic Obstructive Pulmonary Disease (COPD) Assessment scale (CAT)
Quality of life COPD patients scale; from 0 to 40; higher score means a worse outcome
Time frame: Baseline and 4 months
modified Medical Research Council scale (mMRC)
Dyspnea scale; from 0 to 4; higher score means a worse outcome
Time frame: Baseline and 4 months
Plan to share: No
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Bio-Sensing Solutions S.L. (DyCare)