Validation of a Digital Platform for Functional Respiratory Rehabilitation

COPD Clinical Trial

— ReHub  

Official title:

Validation of a Digital Platform for Functional Respiratory Rehabilitation (ReHub)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06252818
• Other study ID #: CVCSD_2301
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Bio-Sensing Solutions S.L. (DyCare)
• Contact: Carme Puy, MD
• Phone: +34935565972
• Email: mpuyr[@]santpau.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COPD

Intervention

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.

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Bio-Sensing Solutions S.L. (DyCare)	Centre de Validació Clínica de Solucions Digitals, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System Usability Scale (SUS)	User satisfaction and experience (Spanish version), from 0 to 100; higher score means a better outcome	4 months
Primary	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	4 months
Primary	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	4 months
Secondary	Walking test_dysnea	Dyspnea level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)	Baseline and 4 months
Secondary	Walking test_fatigue	Fatigue level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)	Baseline and 4 months
Secondary	Walking test_oxygen	SaO2 (oxygen saturation) (pre and post) in percent	Baseline and 4 months
Secondary	Walking test_ heart rate	Heart rate (pre and post) in beats per minute (bpm)	Baseline and 4 months
Secondary	Walking test_distance	Distance walked in meters	Baseline and 4 months
Secondary	Walking test_stops	Number of stops (integer number)	Baseline and 4 months
Secondary	Walking test_stops duration	Stops duration in minutes	Baseline and 4 months
Secondary	Adverse events during exercise	Adverse events during exercise: dyspnea (shortness of breath)	During the exercises
Secondary	Adherence to the platform_frequency	Compliance with the rehabilitation program in terms of frequency of use (number of days connected to the platform)	4 months
Secondary	Adherence to the platform_compliance	Compliance with the rehabilitation program in terms of percent of performed exercices versus prescribed exercices	4 months
Secondary	Adherence to the platform_connection time	Compliance with the rehabilitation program in terms of connection time (in minutes)	4 months
Secondary	Interaction between the physiotherapist and the patient	Number of messages exchanged between the patient and the physiotherapist through ReHub platform	During the follow-up until 4 months
Secondary	Chronic Obstructive Pulmonary Disease (COPD) Assessment scale (CAT)	Quality of life COPD patients scale; from 0 to 40; higher score means a worse outcome	Baseline and 4 months
Secondary	modified Medical Research Council scale (mMRC)	Dyspnea scale; from 0 to 4; higher score means a worse outcome	Baseline and 4 months