Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-03-08 @ 6:01 AM
Study NCT ID:
NCT06998550
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Experiences and the Role of Team Structures in Pulmonary Rehabilitation in Türkiye
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}, 'targetDuration': '5 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Satisfaction Questionnaire', 'timeFrame': 'Within 4 weeks after completion of the pulmonary rehabilitation program', 'description': 'An online survey designed to assess patient experiences and satisfaction levels with pulmonary rehabilitation (PR) programs. The questionnaire covers aspects such as accessibility, communication, program structure, perceived outcomes, and overall satisfaction. It is administered via Google Forms and completed voluntarily by patients who have completed a PR program.'}, {'measure': 'Institutional Survey on PR Program Structure and Team Composition', 'timeFrame': 'Within 4 weeks after completion of the pulmonary rehabilitation program', 'description': 'A structured online questionnaire completed by the designated PR program coordinator or team member. It includes questions on organizational features of the PR program, such as team composition, session frequency, assessment tools, referral and admission criteria, and program setting (inpatient, outpatient, or home-based). This survey aims to document the structural diversity of PR services across different healthcare institutions.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Disease', 'Pulmonary Rehabilitation']}, 'descriptionModule': {'briefSummary': 'The PRETTY Study aims to evaluate patient satisfaction with pulmonary rehabilitation (PR) services across Türkiye and to investigate how satisfaction levels are related to the organizational structures and team compositions of the PR programs. This national, multicenter, cross-sectional observational study will also identify structural and organizational factors that may enhance patient-centered care and promote the standardization of PR services.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Group/Cohort 1 (Label): Patient Group Description: Adults with respiratory disease who have completed a PR program and will complete the Patient Satisfaction Questionnaire.\n\nGroup/Cohort 2 (Label): Program Coordinator Group Description: Healthcare professionals responsible for PR program coordination who will complete the Institutional Survey Form about organizational and team structures.', 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with a respiratory condition (e.g., COPD, interstitial lung disease, asthma, bronchiectasis, etc.)\n* Completed a structured PR program (minimum duration and frequency as defined by national guidelines or center-specific protocols)\n* Willing and able to complete the online Patient Satisfaction Questionnaire\n* Able to provide informed consent\n\nPatient Exclusion Criteria:\n\n* Ongoing participation in a PR program (only completed cases will be included)\n* Inability to complete the questionnaire due to cognitive or language barriers without a caregiver\n\nCoordinator Inclusion Criteria:\n\n* Officially designated as the PR program coordinator or responsible team member\n* Affiliated with a healthcare institution (public, university-affiliated, or private) in Türkiye that provides PR services\n* Willing to complete the Institutional Survey Form regarding team structure, service delivery, and organizational characteristics\n* Authorized by the institution to provide structural data related to the PR unit\n\nCoordinator Exclusion Criteria:\n\n* PR services provided on an informal or ad-hoc basis without a designated team or structure\n* Institutions not offering a structured PR program'}, 'identificationModule': {'nctId': 'NCT06998550', 'briefTitle': 'Patient Experiences and the Role of Team Structures in Pulmonary Rehabilitation in Türkiye', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'Patient Experiences and the Role of Team Structures in Pulmonary Rehabilitation in Türkiye: The PRETTY Study - A National, Multicenter, Cross-Sectional Observational Study', 'orgStudyIdInfo': {'id': 'PRETTY Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PatiePatient Group: Individuals Who Completed a Pulmonary Rehabilitation Programnts', 'description': 'Adult patients with a respiratory disease who have completed a pulmonary rehabilitation (PR) program, regardless of the setting (inpatient, outpatient, or home-based).', 'interventionNames': ['Other: Patient Satisfaction Questionnaire']}, {'label': 'Institutional Representative Group: Pulmonary Rehabilitation Program Coordinators', 'description': 'Healthcare professionals (e.g., physiotherapists, pulmonologists, or allied health staff) who are designated as coordinators or key team members responsible for organizing and managing the pulmonary rehabilitation program in their institution.', 'interventionNames': ['Other: Institutional Survey on PR Program Structure and Team Composition']}], 'interventions': [{'name': 'Patient Satisfaction Questionnaire', 'type': 'OTHER', 'description': 'An online survey designed to assess patient experiences and satisfaction levels with pulmonary rehabilitation (PR) programs. The questionnaire covers aspects such as accessibility, communication, program structure, perceived outcomes, and overall satisfaction. It is administered via Google Forms and completed voluntarily by patients who have completed a PR program.', 'armGroupLabels': ['PatiePatient Group: Individuals Who Completed a Pulmonary Rehabilitation Programnts']}, {'name': 'Institutional Survey on PR Program Structure and Team Composition', 'type': 'OTHER', 'description': 'A structured online questionnaire completed by the designated PR program coordinator or team member. It includes questions on organizational features of the PR program, such as team composition, session frequency, assessment tools, referral and admission', 'armGroupLabels': ['Institutional Representative Group: Pulmonary Rehabilitation Program Coordinators']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34668', 'city': 'Istanbul', 'state': 'Üsküdar', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Esra Pehlivan, Associate Professor', 'role': 'CONTACT', 'email': 'fztesrakambur@yahoo.com', 'phone': '02164189616'}], 'facility': 'Saglik Bilimleri Universitesi', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Esra Pehlivan, Assoc Professor', 'role': 'CONTACT', 'email': 'esra.pehlivan@sbu.edu.tr'}, {'name': 'Fulya Senem Karaahmetoğlu, PT', 'role': 'CONTACT', 'email': 'fulyakaraahmet@gmail.com', 'phone': '+902167778777'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saglik Bilimleri Universitesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'ESRA PEHLIVAN', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}