Validation of a Digital Platform for Functional Respiratory Rehabilitation
- Conditions
- COPD
- Registration Number
- NCT06252818
- Lead Sponsor
- Bio-Sensing Solutions S.L. (DyCare)
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Patients with COPD, GOLD grade I - IV
- Need of respiratory rehabilitation.
- 18 years of age or older.
- Explicit willingness to participate in the study.
- Diagnosis of COPD (FEV1/FVC < 70)
- Individuals with cognitive impairment.
- Language barriers or illiteracy (inability to read in Spanish).
- Lack of access to a mobile device with an internet connection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method System Usability Scale (SUS) 4 months User satisfaction and experience (Spanish version), from 0 to 100; higher score means a better outcome
Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications (pSUAPP-S) for Patients 4 months Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications for patients, from 0 to 100; higher score means a better outcome
Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications (pSUAPP-S) for Healthcare Professionals 4 months Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications for Healthcare professionals, from 0 to 100; higher score means a better outcome
- Secondary Outcome Measures
Name Time Method Walking test_distance Baseline and 4 months Distance walked in meters
Walking test_oxygen Baseline and 4 months SaO2 (oxygen saturation) (pre and post) in percent
Walking test_stops Baseline and 4 months Number of stops (integer number)
Walking test_dysnea Baseline and 4 months Dyspnea level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)
Walking test_ heart rate Baseline and 4 months Heart rate (pre and post) in beats per minute (bpm)
Adherence to the platform_connection time 4 months Compliance with the rehabilitation program in terms of connection time (in minutes)
Chronic Obstructive Pulmonary Disease (COPD) Assessment scale (CAT) Baseline and 4 months Quality of life COPD patients scale; from 0 to 40; higher score means a worse outcome
Walking test_fatigue Baseline and 4 months Fatigue level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)
Walking test_stops duration Baseline and 4 months Stops duration in minutes
Adherence to the platform_frequency 4 months Compliance with the rehabilitation program in terms of frequency of use (number of days connected to the platform)
modified Medical Research Council scale (mMRC) Baseline and 4 months Dyspnea scale; from 0 to 4; higher score means a worse outcome
Adverse events during exercise During the exercises Adverse events during exercise: dyspnea (shortness of breath)
Adherence to the platform_compliance 4 months Compliance with the rehabilitation program in terms of percent of performed exercices versus prescribed exercices
Interaction between the physiotherapist and the patient During the follow-up until 4 months Number of messages exchanged between the patient and the physiotherapist through ReHub platform
Trial Locations
- Locations (1)
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau🇪🇸Barcelona, Spain