COPD
Conditions
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.
Interventions
DEVICEReHub
ReHub provides support to rehabilitation professionals by offering information for the design, monitoring, and analysis of therapeutic exercise programs for respiratory functional rehabilitation.
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Centre de Validació Clínica de Solucions Digitals
Bio-Sensing Solutions S.L. (DyCare)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* Individuals with cognitive impairment. * Language barriers or illiteracy (inability to read in Spanish). * Lack of access to a mobile device with an internet connection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Walking test_ heart rate | Baseline and 4 months | Heart rate (pre and post) in beats per minute (bpm) |
| Walking test_distance | Baseline and 4 months | Distance walked in meters |
| Walking test_stops | Baseline and 4 months | Number of stops (integer number) |
| Walking test_stops duration | Baseline and 4 months | Stops duration in minutes |
| Adverse events during exercise | During the exercises | Adverse events during exercise: dyspnea (shortness of breath) |
| Walking test_dysnea | Baseline and 4 months | Dyspnea level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum) |
| Adherence to the platform_compliance | 4 months | Compliance with the rehabilitation program in terms of percent of performed exercices versus prescribed exercices |
| Adherence to the platform_connection time | 4 months | Compliance with the rehabilitation program in terms of connection time (in minutes) |
| 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 |
| 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 |
| modified Medical Research Council scale (mMRC) | Baseline and 4 months | Dyspnea scale; from 0 to 4; higher score means a worse outcome |
| 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) |
| 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_oxygen | Baseline and 4 months | SaO2 (oxygen saturation) (pre and post) in percent |
Countries
Spain
Contacts
Primary ContactCarme Puy, MD
Outcome results
None listed