Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-24 @ 8:26 AM
Study NCT ID:
NCT04405635
Status:
RECRUITING
Last Update Posted:
2023-12-07
First Post:
2020-05-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-06', 'studyFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Health today', 'timeFrame': 'Every day throughout 90 days', 'description': 'One question about subjective health, VAS 0-100 (better)'}], 'primaryOutcomes': [{'measure': 'Different parameters of digital behavior', 'timeFrame': 'Continuously throughout the 90 days of monitoring', 'description': 'Number of interactions with the smart phone, tapping speed, typing speed, social media use'}], 'secondaryOutcomes': [{'measure': 'EQ5D', 'timeFrame': 'Once a week during 12 weeks', 'description': 'Health related quality of life, 5 point subscale, Index values of 0-1 (better), EQ5D VAS 0-100 (better)'}, {'measure': 'Mini MoCA', 'timeFrame': '3 times in three months, after 4, 8 and 12 weeks', 'description': 'Montreal Cognitive Assessment, cognitive function, scale 0-15 (better)'}, {'measure': 'SF-36', 'timeFrame': '3 times in three months, after 4, 8 and 12 weeks', 'description': 'Health related quality of life, 0-100 (better)'}, {'measure': 'Stroke Specific Quality of Life Questionnaire - short version', 'timeFrame': '3 times in three months, after 4, 8 and 12 weeks', 'description': 'Stroke related quality of life, 12-60 (better)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke, digital behavior, health-related quality of life, cognitive function'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'In this study, we want to continuously record the interaction of 50 stroke survivors with their smartphones during the first 3 months after discharge. The linkage of smart phone use to function and quality of life will be assessed with standardized outcome measures at defined time points.', 'detailedDescription': 'People with stroke are among the most relevant target groups for unobtrusive monitoring. Worldwide, stroke is the second most frequent cause for lasting disability and causes a substantial burden for the individual, caregivers and society. Thanks to improved treatment, many stroke survivors can be discharged to their homes. However, many have to live with disabilities and are prone to declining function, cognitive impairment and depression. With the acquired data, we want to create a database where digital behavior is analyzed with advanced computational methods. In collaboration with the Department of Cognitive Psychology, University of Leiden, Netherlands, these data will be used to discover specific features for different health issues and to develop tools for the early detection of functional decline for different populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We want to include a broad range of patients with stroke, incuding both ischemic and hemorrhagic strokes and different impairments due to stroke. Patients are recruited at two wards specialized in neurorehabilitation around 1 week before discharge to their home.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New or recurrent stroke, admitted to rehabilitation, discharge to own home\n* Owns an Android smart phone\n* Smart phone is used by the patient only\n\nExclusion Criteria:\n\n* Severe cognitive impairments and / or psychiatric and behavioral conditions that interfere with compliance.\n* Not able to provide informed consent\n* Discharge to nursing homes or other care facilities'}, 'identificationModule': {'nctId': 'NCT04405635', 'acronym': 'QuantStroke', 'briefTitle': 'Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Quantifying Digital Behavior on Smart Phones - Data From Stroke Survivors', 'orgStudyIdInfo': {'id': '614731'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention or exposure', 'type': 'OTHER', 'description': 'No intervention or exposure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8450', 'city': 'Hammel', 'state': 'Aarhus', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Iris Brunner, PhD', 'role': 'CONTACT', 'email': 'Iris.Brunner@rm.dk', 'phone': '+4560568195'}], 'facility': 'Hammel Neurorehabilitation Centre and University Research Clinic', 'geoPoint': {'lat': 56.25762, 'lon': 9.86316}}], 'centralContacts': [{'name': 'Iris Brunner, PhD', 'role': 'CONTACT', 'email': 'Iris.Brunner@rm.dk', 'phone': '+4560568195'}, {'name': 'Jørgen Feldbæk Nielsen, PhD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Iris C. Brunner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aarhus University, Hammel Neurocenter'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Processed smartphone behavioral data and the associated processing codes will be made available upon publication and corresponding release in data repositories.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Leiden University', 'class': 'OTHER'}, {'name': 'Carlsberg Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}