Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04479969
Status:
COMPLETED
Last Update Posted:
2022-07-08
First Post:
2020-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enabling Independent Living by Expanding Access to Home-Based Pulmonary 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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2020-07-17', 'studyFirstSubmitQcDate': '2020-07-17', 'lastUpdatePostDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative Interview', 'timeFrame': 'Week 1', 'description': 'A Qualitative Interview will be conducted over the phone asking about the video chat experience.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test an existing home-based pulmonary rehab program with the addition of video chat and a capability of a Spanish version.', 'detailedDescription': "The purpose of this research is to test video chat on a computer tablet that is used for Pulmonary Rehabilitation. We are interested in learning patients' thoughts on how easy or difficult video chat is to use and the translation to Spanish and the feed back from Spanish speaking patients ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be ≥ 40 years old.\n* Patients mist have a diagnosis of GOLD stage II, III, or IV COPD documented by pulmonary function testing.\n* Patients must be a current or previous smoker with at least 10 pack-years of cigarette smoking.\n\nAdditional Inclusion Criteria to test Spanish version of system:\n\n* Be a native Spanish speaker.\n\nExclusion Criteria:\n\n* Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency).\n* Patients planning to move out of the state or who are not living in the healthcare area.\n* Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).'}, 'identificationModule': {'nctId': 'NCT04479969', 'briefTitle': 'Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Enabling Independent Living by Expanding Access to Home-Based Pulmonary Rehabilitation', 'orgStudyIdInfo': {'id': '20-003806'}, 'secondaryIdInfos': [{'id': '1R43HL151461', 'link': 'https://reporter.nih.gov/quickSearch/1R43HL151461', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', 'description': 'This is a small study to assess the usability of video conferencing. A total of 10 patients will be enrolled, 5 of which will be Spanish speakers. All patients will test the video conferencing.', 'interventionNames': ['Behavioral: Video Chat']}], 'interventions': [{'name': 'Video Chat', 'type': 'BEHAVIORAL', 'description': 'Video chat with health coach using a computer tablet.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Roberto P Benzo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Roberto P. Benzo', 'investigatorAffiliation': 'Mayo Clinic'}}}}