Validation of a Digital Platform for Functional Respiratory Rehabilitation

NCT06252818 | Recruiting DMC

• 1 other identifier: CVCSD_2301
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

COPD

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (14)

• Walking test_dysnea

  Baseline and 4 months

• Walking test_fatigue

  Baseline and 4 months

• Walking test_oxygen

  Baseline and 4 months

• Walking test_ heart rate

  Baseline and 4 months

• Walking test_distance

  Baseline and 4 months

Study Arms (1)

ReHub

EXPERIMENTAL

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

Interventions

ReHub DEVICE

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

ReHub

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with COPD, GOLD grade I - IV
• Need of respiratory rehabilitation.
• years of age or older.
• Explicit willingness to participate in the study.
• Diagnosis of COPD (FEV1/FVC \< 70)

You may not qualify if:

• Individuals with cognitive impairment.
• Language barriers or illiteracy (inability to read in Spanish).
• Lack of access to a mobile device with an internet connection.

Sponsors & Collaborators

• Bio-Sensing Solutions S.L. (DyCare): lead
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Centre de Validació Clínica de Solucions Digitals: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Carme Puy, MD

  Pneumologist at Hospital Santa Creu i Sant Pau

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carme Puy, MD

CONTACT

+34935565972; mpuyr@santpau.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 12, 2024
• Study Start: March 7, 2024
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)