Clinical trial NCT06252818: Validation of a Digital Platform for Functional Respiratory Rehabilitation
Official title: Validation of a Digital Platform for Functional Respiratory Rehabilitation (ReHub)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD
Lead sponsor: Bio-Sensing Solutions S.L. (DyCare)
Sponsor class: INDUSTRY
Collaborators: name: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Centre de Validació Clínica de Solucions Digitals
First posted: 2024-02-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: System Usability Scale (SUS)
timeFrame: 4 months
measure: Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications (pSUAPP-S) for Patients
timeFrame: 4 months
measure: Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications (pSUAPP-S) for Healthcare Professionals
timeFrame: 4 months
Secondary outcomes:
measure: Walking test_dysnea
timeFrame: Baseline and 4 months
measure: Walking test_fatigue
timeFrame: Baseline and 4 months
measure: Walking test_oxygen
timeFrame: Baseline and 4 months
measure: Walking test_ heart rate
timeFrame: Baseline and 4 months
measure: Walking test_distance
timeFrame: Baseline and 4 months
measure: Walking test_stops
timeFrame: Baseline and 4 months
measure: Walking test_stops duration
timeFrame: Baseline and 4 months
measure: Adverse events during exercise
timeFrame: During the exercises
measure: Adherence to the platform_frequency
timeFrame: 4 months
measure: Adherence to the platform_compliance
timeFrame: 4 months
measure: Adherence to the platform_connection time
timeFrame: 4 months
measure: Interaction between the physiotherapist and the patient
timeFrame: During the follow-up until 4 months
measure: Chronic Obstructive Pulmonary Disease (COPD) Assessment scale (CAT)
timeFrame: Baseline and 4 months
measure: modified Medical Research Council scale (mMRC)
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Pneumologist at Hospital Santa Creu i Sant Pau
name: Carme Puy, MD
role: PRINCIPAL_INVESTIGATOR
References: