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

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

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).

Study Overview

• Status: Recruiting
• Conditions: COPD
• Intervention / Treatment: Device: ReHub

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carme Puy, MD; Phone Number: +34935565972; Email: mpuyr@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital De La Santa Creu I Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ReHub; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Scale (SUS)	User satisfaction and experience (Spanish version), from 0 to 100; higher score means a better outcome	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	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	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking test_dysnea	Dyspnea level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)	Baseline and 4 months
Walking test_fatigue	Fatigue level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)	Baseline and 4 months
Walking test_ heart rate	Heart rate (pre and post) in beats per minute (bpm)	Baseline and 4 months
Walking test_distance	Distance walked in meters	Baseline and 4 months
Walking test_stops	Number of stops (integer number)	Baseline and 4 months
Walking test_stops duration	Stops duration in minutes	Baseline and 4 months
Adverse events during exercise	Adverse events during exercise: dyspnea (shortness of breath)	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)	4 months
Adherence to the platform_connection time	Compliance with the rehabilitation program in terms of connection time (in minutes)	4 months
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
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
modified Medical Research Council scale (mMRC)	Dyspnea scale; from 0 to 4; higher score means a worse outcome	Baseline and 4 months
Walking test_oxygen	SaO2 (oxygen saturation) (pre and post) in percent	Baseline and 4 months
Adherence to the platform_compliance	Compliance with the rehabilitation program in terms of percent of performed exercices versus prescribed exercices	4 months

Collaborators and Investigators

• Sponsor: Bio-Sensing Solutions S.L. (DyCare)
• Collaborators: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre de Validació Clínica de Solucions Digitals
• Investigators: Principal Investigator: Carme Puy, MD, Pneumologist at Hospital Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 24, 2024
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 2, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CVCSD_2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No