COPDReHubNCT06252818
Validation of a Digital Platform for Functional Respiratory Rehabilitation
A study testing ReHub in people with COPD, run by Bio-Sensing Solutions S.L. (DyCare) at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD
- What is being tested?
- ReHub
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 7 Mar 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Individuals with cognitive impairment.
- Language barriers or illiteracy (inability to read in Spanish).
- Lack of access to a mobile device with an internet connection.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
About this study
Official title: 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).
Read the 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
- Being tested
- ReHub
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReHubDevice
ReHub provides support to rehabilitation professionals by offering information for the design, monitoring, and analysis of therapeutic exercise programs for respiratory functional rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ReHub |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Scale (SUS)
User satisfaction and experience (Spanish version), from 0 to 100; higher score means a better outcome
Measured: 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
Measured: 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
Measured: 4 months
Secondary outcomes (14)
Walking test_dysnea
Dyspnea level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)
Measured: Baseline and 4 months
Walking test_fatigue
Fatigue level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)
Measured: Baseline and 4 months
Walking test_oxygen
SaO2 (oxygen saturation) (pre and post) in percent
Measured: Baseline and 4 months
Walking test_ heart rate
Heart rate (pre and post) in beats per minute (bpm)
Measured: Baseline and 4 months
Walking test_distance
Distance walked in meters
Measured: Baseline and 4 months
Walking test_stops
Number of stops (integer number)
Measured: Baseline and 4 months
Walking test_stops duration
Stops duration in minutes
Measured: Baseline and 4 months
Adverse events during exercise
Adverse events during exercise: dyspnea (shortness of breath)
Measured: 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)
Measured: 4 months
Adherence to the platform_compliance
Compliance with the rehabilitation program in terms of percent of performed exercices versus prescribed exercices
Measured: 4 months
Adherence to the platform_connection time
Compliance with the rehabilitation program in terms of connection time (in minutes)
Measured: 4 months
Interaction between the physiotherapist and the patient
Number of messages exchanged between the patient and the physiotherapist through ReHub platform
Measured: 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
Measured: Baseline and 4 months
modified Medical Research Council scale (mMRC)
Dyspnea scale; from 0 to 4; higher score means a worse outcome
Measured: Baseline and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start7 Mar 2024
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bio-Sensing Solutions S.L. (DyCare)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Centre de Validació Clínica de Solucions Digitals
- Responsible party
- Sponsor
- Investigators
- Carme Puy, MD, Principal investigator, Pneumologist at Hospital Santa Creu i Sant Pau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252818
- Sponsor's protocol ID
- CVCSD_2301
- Acronym
- ReHub
- Status last verified
- May 2024
- First submitted
- 24 Jan 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Digital Platform for Functional Respiratory Rehabilitation (ReHub)
- ClinicalTrials.gov ID
- NCT06252818
- Acronym / sponsor ID
- ReHub / CVCSD_2301
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bio-Sensing Solutions S.L. (DyCare)Industry (pharma, biotech, devices)
- Collaborators
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Centre de Validació Clínica de Solucions Digitals
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| ReHub | Experimental | Device: ReHubReHub 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Individuals with cognitive impairment.
- Language barriers or illiteracy (inability to read in Spanish).
- Lack of access to a mobile device with an internet connection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReHubReHub provides support to rehabilitation professionals by offering information for the design, monitoring, and analysis of therapeutic exercise programs for respiratory functional rehabilitation. | Device | ReHub |
Primary outcome
System Usability Scale (SUS)
Time frame: 4 months
User satisfaction and experience (Spanish version), from 0 to 100; higher score means a better outcome
Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications (pSUAPP-S) for Patients
Time frame: 4 months
Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications for patients, from 0 to 100; higher score means a better outcome
Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications (pSUAPP-S) for Healthcare Professionals
Time frame: 4 months
Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications for Healthcare professionals, from 0 to 100; higher score means a better outcome
14 secondary outcomes
Walking test_dysnea
Time frame: Baseline and 4 months
Walking test_fatigue
Time frame: Baseline and 4 months
Walking test_oxygen
Time frame: Baseline and 4 months
Walking test_ heart rate
Time frame: Baseline and 4 months
Walking test_distance
Time frame: Baseline and 4 months
Walking test_stops
Time frame: Baseline and 4 months
Walking test_stops duration
Time frame: Baseline and 4 months
Adverse events during exercise
Time frame: During the exercises
Adherence to the platform_frequency
Time frame: 4 months
Adherence to the platform_compliance
Time frame: 4 months
Adherence to the platform_connection time
Time frame: 4 months
Interaction between the physiotherapist and the patient
Time frame: During the follow-up until 4 months
Chronic Obstructive Pulmonary Disease (COPD) Assessment scale (CAT)
Time frame: Baseline and 4 months
modified Medical Research Council scale (mMRC)
Time frame: Baseline and 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carme Puy, MD principal investigator
Pneumologist at Hospital Santa Creu i Sant Pau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReHub in people with COPD, run by Bio-Sensing Solutions S.L. (DyCare) at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carme Puy, MD (+34935565972, mpuyr@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Usability Scale (SUS) (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.