Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-27 @ 6:42 PM
Study NCT ID:
NCT05680259
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-10
First Post:
2022-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-02-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2023-01-10', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of number of well-being patients in both groups', 'timeFrame': 'two months', 'description': 'Variation of number of well-being patients in both groups'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mobile app follow-up', 'lumbar spine surgery', 'Quality of Life', 'Pain'], 'conditions': ['Lumbar Spine Surgery', 'Quality of Life', 'Pain']}, 'descriptionModule': {'briefSummary': 'Digital technologies could reduce the length of hospital stay and improve post-operative recuperation after discharge by offering a remote follow-up. No study has investigated the effects of connected follow-up on lumbar spine inpatients.\n\nThe purpose of this project is to assess the effects of connected follow-up on pain and quality of life after lumbar spine surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First ever lumbar spine surgery in the context of a degenerative spinal pathology\n* Age between 18 and 60 yo\n* Providing free and informed consent to participate\n* Having a smartphone able to process MAELA application'}, 'identificationModule': {'nctId': 'NCT05680259', 'acronym': 'HOSPITEL', 'briefTitle': 'Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Assessment of the Effects of Maela Connected Follow-up on Well-being and Pain After Lumbar Spine Surgery', 'orgStudyIdInfo': {'id': 'PI2019_843_0016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maela connected follow-up', 'description': 'patient will benefit of the Maela connected follow-up', 'interventionNames': ['Other: Maela connected follow-up']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'control group with a traditional follow-up', 'interventionNames': ['Other: traditional follow-up']}], 'interventions': [{'name': 'Maela connected follow-up', 'type': 'OTHER', 'description': 'Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.', 'armGroupLabels': ['Maela connected follow-up']}, {'name': 'traditional follow-up', 'type': 'OTHER', 'description': 'medical recommendations and prescriptions at hospital discharge. Measures of pain, quality of life and health related variables (coping, self-efficacy, beliefs about pain) will be done at four times before and after surgery.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}