Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-21 @ 6:14 AM
Study NCT ID:
NCT03114293
Status:
UNKNOWN
Last Update Posted:
2017-05-03
First Post:
2017-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Rater blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Short, randomised waiting-group controlled explorative studies of a behavioural intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2017-03-31', 'studyFirstSubmitQcDate': '2017-04-13', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of responders', 'timeFrame': '3 Months', 'description': 'Rate of responders as defined by a 20% increase of steps or 20% increase in physical activity as measured with the actigraph'}], 'secondaryOutcomes': [{'measure': 'Physical activity: total activity', 'timeFrame': '3 Months', 'description': 'Physical activity and real-life mobility: 1-week accelerometry (actigraph)'}, {'measure': 'Physical activity: distance per day', 'timeFrame': '3 Months', 'description': 'Physical activity and real-life mobility: 1-week accelerometry (actigraph)'}, {'measure': 'Physical activity: number of steps per day', 'timeFrame': '3 Months', 'description': 'Physical activity and real-life mobility: 1-week accelerometry (actigraph)'}, {'measure': 'Questionnaires on quality of life (QoL, HAQUAMS)', 'timeFrame': '3 Months', 'description': 'Disease specific quality of life questionnaire'}, {'measure': 'Questionnaires on activities of daily living (ADL)', 'timeFrame': '3 Months', 'description': 'Frenchay activity index'}, {'measure': 'Questionnaires on physical activity', 'timeFrame': '3 Months', 'description': 'Godin Leisure time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Physical activity', 'Mobility'], 'conditions': ['Multiple Sclerosis, Chronic Progressive']}, 'descriptionModule': {'briefSummary': 'Due to their ubiquitary distribution, smartphones might serve as an easy way/ possibility to use feedback mechanism in an app-based intervention program to increase physical activity in Multiple Sclerosis (MS) patients. Internet based cognitive-behavioral interventions have been explored as effective in the last years. In addition, smartphone-based mobility assessment and intervention might be a promising approach in other MS types and for real-life mobility assessment in observational and interventional trials. The aim is to investigate the impact of a smartphone based information and feedback program on physical activity in a 3 months, randomised waiting-group controlled trial of 40 progressive MS patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* progressive MS\n\nExclusion Criteria:\n\n* other major health disorder\n* EDSS above 6'}, 'identificationModule': {'nctId': 'NCT03114293', 'acronym': 'PIA', 'briefTitle': 'Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsklinikum Hamburg-Eppendorf'}, 'officialTitle': 'Evidence Based Patient Information and Smartphone Accelerometry to Enhance Physical Activity in MS', 'orgStudyIdInfo': {'id': 'inims-pia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Waiting group', 'description': 'Waiting group'}, {'type': 'EXPERIMENTAL', 'label': 'Smartphone intervention', 'description': 'Smartphone bases behavioural intervention', 'interventionNames': ['Behavioral: Smartphone App']}], 'interventions': [{'name': 'Smartphone App', 'type': 'BEHAVIORAL', 'description': 'The app includes an EBPI and physical activity feedback', 'armGroupLabels': ['Smartphone intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jan-Patrick Stellmann', 'investigatorAffiliation': 'Universitätsklinikum Hamburg-Eppendorf'}}}}