Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT06252818
Status:
RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation of a Digital Platform for Functional Respiratory Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-02', 'studyFirstSubmitDate': '2024-01-24', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Usability Scale (SUS)', 'timeFrame': '4 months', 'description': 'User satisfaction and experience (Spanish version), from 0 to 100; higher score means a better outcome'}, {'measure': 'Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications (pSUAPP-S) for Patients', 'timeFrame': '4 months', 'description': 'Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications for patients, from 0 to 100; higher score means a better outcome'}, {'measure': 'Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications (pSUAPP-S) for Healthcare Professionals', 'timeFrame': '4 months', 'description': 'Satisfaction and Usability Questionnaire with Comprehensive Outpatient follow-up health applications for Healthcare professionals, from 0 to 100; higher score means a better outcome'}], 'secondaryOutcomes': [{'measure': 'Walking test_dysnea', 'timeFrame': 'Baseline and 4 months', 'description': 'Dyspnea level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)'}, {'measure': 'Walking test_fatigue', 'timeFrame': 'Baseline and 4 months', 'description': 'Fatigue level (pre and post) assessed by Borg Scale (number from 0 none to 10 maximum)'}, {'measure': 'Walking test_oxygen', 'timeFrame': 'Baseline and 4 months', 'description': 'SaO2 (oxygen saturation) (pre and post) in percent'}, {'measure': 'Walking test_ heart rate', 'timeFrame': 'Baseline and 4 months', 'description': 'Heart rate (pre and post) in beats per minute (bpm)'}, {'measure': 'Walking test_distance', 'timeFrame': 'Baseline and 4 months', 'description': 'Distance walked in meters'}, {'measure': 'Walking test_stops', 'timeFrame': 'Baseline and 4 months', 'description': 'Number of stops (integer number)'}, {'measure': 'Walking test_stops duration', 'timeFrame': 'Baseline and 4 months', 'description': 'Stops duration in minutes'}, {'measure': 'Adverse events during exercise', 'timeFrame': 'During the exercises', 'description': 'Adverse events during exercise: dyspnea (shortness of breath)'}, {'measure': 'Adherence to the platform_frequency', 'timeFrame': '4 months', 'description': 'Compliance with the rehabilitation program in terms of frequency of use (number of days connected to the platform)'}, {'measure': 'Adherence to the platform_compliance', 'timeFrame': '4 months', 'description': 'Compliance with the rehabilitation program in terms of percent of performed exercices versus prescribed exercices'}, {'measure': 'Adherence to the platform_connection time', 'timeFrame': '4 months', 'description': 'Compliance with the rehabilitation program in terms of connection time (in minutes)'}, {'measure': 'Interaction between the physiotherapist and the patient', 'timeFrame': 'During the follow-up until 4 months', 'description': 'Number of messages exchanged between the patient and the physiotherapist through ReHub platform'}, {'measure': 'Chronic Obstructive Pulmonary Disease (COPD) Assessment scale (CAT)', 'timeFrame': 'Baseline and 4 months', 'description': 'Quality of life COPD patients scale; from 0 to 40; higher score means a worse outcome'}, {'measure': 'modified Medical Research Council scale (mMRC)', 'timeFrame': 'Baseline and 4 months', 'description': 'Dyspnea scale; from 0 to 4; higher score means a worse outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.\n\nReHub 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.\n\nThe 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.\n\nMethology:\n\nSingle-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).\n\nRecruitment 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.\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with COPD, GOLD grade I - IV\n* Need of respiratory rehabilitation.\n* 18 years of age or older.\n* Explicit willingness to participate in the study.\n* Diagnosis of COPD (FEV1/FVC \\< 70)\n\nExclusion Criteria:\n\n* Individuals with cognitive impairment.\n* Language barriers or illiteracy (inability to read in Spanish).\n* Lack of access to a mobile device with an internet connection.'}, 'identificationModule': {'nctId': 'NCT06252818', 'acronym': 'ReHub', 'briefTitle': 'Validation of a Digital Platform for Functional Respiratory Rehabilitation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bio-Sensing Solutions S.L. (DyCare)'}, 'officialTitle': 'Validation of a Digital Platform for Functional Respiratory Rehabilitation (ReHub)', 'orgStudyIdInfo': {'id': 'CVCSD_2301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ReHub', '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.', 'interventionNames': ['Device: ReHub']}], 'interventions': [{'name': 'ReHub', 'type': 'DEVICE', 'description': 'ReHub provides support to rehabilitation professionals by offering information for the design, monitoring, and analysis of therapeutic exercise programs for respiratory functional rehabilitation.', 'armGroupLabels': ['ReHub']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08041', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Carme Puy, MD', 'role': 'CONTACT', 'email': 'mpuyr@santpau.cat', 'phone': '+34935565972'}], 'overallOfficials': [{'name': 'Carme Puy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pneumologist at Hospital Santa Creu i Sant Pau'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bio-Sensing Solutions S.L. (DyCare)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, {'name': 'Centre de Validació Clínica de Solucions Digitals', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}