Validation of a Digital Platform for Functional Respiratory Rehabilitation

NCT ID: NCT06252818

Last Updated: 2024-05-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2024-12-31

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.

Conditions

COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ReHub

Intervention Type: DEVICE

ReHub provides support to rehabilitation professionals by offering information for the design, monitoring, and analysis of therapeutic exercise programs for respiratory functional rehabilitation.

Interventions

ReHub

ReHub provides support to rehabilitation professionals by offering information for the design, monitoring, and analysis of therapeutic exercise programs for respiratory functional rehabilitation.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: collaborator

Centre de Validació Clínica de Solucions Digitals

UNKNOWN

Sponsor Role: collaborator

Bio-Sensing Solutions S.L. (DyCare)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carme Puy, MD

Role: PRINCIPAL_INVESTIGATOR

Pneumologist at Hospital Santa Creu i Sant Pau

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Carme Puy, MD

Role: CONTACT

mpuyr@santpau.cat

+34935565972

Other Identifiers

CVCSD_2301

Identifier Type: -

Identifier Source: org_study_id