Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT04359160
Status:
COMPLETED
Last Update Posted:
2021-01-14
First Post:
2020-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Follow-up by Mobile App or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-12', 'studyFirstSubmitDate': '2020-04-20', 'studyFirstSubmitQcDate': '2020-04-22', 'lastUpdatePostDateStruct': {'date': '2021-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return rate', 'timeFrame': '6 weeks postoperative', 'description': 'The overall response rate to the questionnaires'}], 'secondaryOutcomes': [{'measure': 'The quality of the responses', 'timeFrame': '6 weeks postoperative', 'description': 'response rate inside the questionnaire'}, {'measure': 'Net Promoter Score (NPS)', 'timeFrame': '6 weeks postoperative', 'description': 'whether or not the patient recommended the questionnaire used, a scale of 0 (not at all likely) to 10 (very likely)'}, {'measure': 'Overall patient satisfaction', 'timeFrame': '6 weeks postoperative', 'description': 'whether or not the patient is satisfied of the questionnaire used, a scale of 0 (not at all) to 10 (very good)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mobile App', 'Rotator Cuff', 'Outpatient surgery', 'Follow-up'], 'conditions': ['Rotator Cuff Injuries']}, 'referencesModule': {'references': [{'pmid': '29738599', 'type': 'BACKGROUND', 'citation': 'Gil JA, Durand WM, Johnson JP, Goodman AD, Owens BD, Daniels AH. Unanticipated Admission Following Outpatient Rotator Cuff Repair: An Analysis of 18,061 Cases. Orthopedics. 2018 May 1;41(3):164-168. doi: 10.3928/01477447-20180501-04. Epub 2018 May 9.'}, {'pmid': '30560289', 'type': 'BACKGROUND', 'citation': 'Calvo E, Torres MD, Morcillo D, Leal V. Rotator cuff repair is more painful than other arthroscopic shoulder procedures. Arch Orthop Trauma Surg. 2019 May;139(5):669-674. doi: 10.1007/s00402-018-3100-0. Epub 2018 Dec 17.'}, {'pmid': '30021075', 'type': 'BACKGROUND', 'citation': 'Kosinski LR, Gil JA, Durand WM, DeFroda SF, Owens BD, Daniels AH. 30-Day readmission following outpatient rotator cuff repair: an analysis of 18,061 cases. Phys Sportsmed. 2018 Nov;46(4):466-470. doi: 10.1080/00913847.2018.1502571. Epub 2018 Jul 27.'}, {'pmid': '29318171', 'type': 'BACKGROUND', 'citation': 'Higgins J, Semple J, Murnaghan L, Sharpe S, Theodoropoulos J. Mobile Web-Based Follow-up for Postoperative ACL Reconstruction: A Single-Center Experience. Orthop J Sports Med. 2017 Dec 22;5(12):2325967117745278. doi: 10.1177/2325967117745278. eCollection 2017 Dec.'}, {'pmid': '28329223', 'type': 'BACKGROUND', 'citation': 'Armstrong KA, Coyte PC, Brown M, Beber B, Semple JL. Effect of Home Monitoring via Mobile App on the Number of In-Person Visits Following Ambulatory Surgery: A Randomized Clinical Trial. JAMA Surg. 2017 Jul 1;152(7):622-627. doi: 10.1001/jamasurg.2017.0111.'}, {'pmid': '36403889', 'type': 'DERIVED', 'citation': 'Descamps J, Le Hanneur M, Bouche PA, Boukebous B, Duranthon LD, Grimberg J. Do web-based follow-up surveys have a better response rate than traditional paper-based questionnaires following outpatient arthroscopic rotator cuff repair? A randomized controlled trial. Orthop Traumatol Surg Res. 2023 Apr;109(2):103479. doi: 10.1016/j.otsr.2022.103479. Epub 2022 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluate if in an outpatient rotator cuff surgery, can the use of mobile app compared to conventional paper questionnaire improve follow-up care in the first 90-days following surgery.', 'detailedDescription': 'Rotator cuff surgery is a painful arthroscopic surgery. In outpatient surgery, the surgeons have to increase the security and surveillance after the surgery to reassure the patient and avoid complications.\n\nMost patients receiving ambulatory rotator cuff surgery have high pain score, and management and aspects of the rehabilitation can be challenging. However, regular follow-up is still considered important in the early post-operative phase. In between the conventional appointment 6 weeks post op and 12 weeks post op, the surgeons have no status of the patient, and no markers to check if the postoperative care is evolving right.\n\nCurrently, the investigators are using a mobile application (Orthense by Digikare, Blagnac, France) to complement in-person postoperative follow-up care for patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing rotator cuff surgery. They must be able to use a mobile-app, and have an email address and internet connexion.\n\nExclusion Criteria:\n\n* Unable to read French'}, 'identificationModule': {'nctId': 'NCT04359160', 'acronym': 'OFUE', 'briefTitle': 'Comparison of Follow-up by Mobile App or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery', 'organization': {'class': 'OTHER', 'fullName': "L'Institut de Recherche en Chirurgie Orthopédique et Sportive"}, 'officialTitle': 'Comparison of Follow-up by Mobile Application or Paper Questionnaire of Patients Undergoing Rotator Cuff Surgery: Monocentric, Prospective, Randomized Study', 'orgStudyIdInfo': {'id': '2020 0016 J'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile-app follow-up', 'description': "The mobile app follow-up group will receive an email, to connect into a secure website. They will answer to periodical questions about their condition. They will have a medical appointment at 6 weeks postoperative and 12 weeks postoperative. All of this information is submitted via the mobile application (Orthense, Digikare Inc. Blagnac, France).The surgeon will have an access to the answer of the patient in real time, and if the patient didn't answer.", 'interventionNames': ['Device: Orthense, Orthense, Digikare Inc. Blagnac, France']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional follow-up', 'description': 'Patients in the conventional, questionnaire follow-up group will have the same periodical questions but on paper. They will have to stick personally with the schedule without any reminders. They will have a medical appointment at 6 weeks postoperative and 12 weeks postoperative where they have to bring the questionnaire.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Orthense, Orthense, Digikare Inc. Blagnac, France', 'type': 'DEVICE', 'description': 'Mobile-app follow-up care, with questions and score', 'armGroupLabels': ['Mobile-app follow-up']}, {'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Paper questionnaire follow-up, with questions and score', 'armGroupLabels': ['Conventional follow-up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75016', 'city': 'Paris', 'country': 'France', 'facility': 'Clinique Jouvenet', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean Grimberg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': "L'Institut de Recherche en Chirurgie Orthopédique et Sportive"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "L'Institut de Recherche en Chirurgie Orthopédique et Sportive", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}