Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-03-12 @ 8:08 PM
Study NCT ID:
NCT03648593
Status:
UNKNOWN
Last Update Posted:
2018-08-27
First Post:
2018-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promo@Work Entrepreneurs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015438', 'term': 'Health Behavior'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'randomized intervention trial with waiting list control'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1256}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2019-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-24', 'studyFirstSubmitDate': '2018-05-24', 'studyFirstSubmitQcDate': '2018-08-24', 'lastUpdatePostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'dose of intervention', 'timeFrame': 'from baseline until 2 months', 'description': 'dose of Recover application (using time in hours and minutes during two months)'}], 'primaryOutcomes': [{'measure': 'change from baseline in need for recovery scale at 6 months', 'timeFrame': 'change from baseline in need for recovery scale at 6 months', 'description': 'need for recovery scale measures early symptoms of fatigue'}, {'measure': 'change from baseline in perceived work ability at 6 months. One item of work ability index', 'timeFrame': 'change from baseline in perceived work ability at 6 months', 'description': 'to rate their work ability on a scale of 0 to 10, ten being their lifetime best work ability'}], 'secondaryOutcomes': [{'measure': 'change from baseline in 3-item version of the Utrecht Work Engagement Scale at 6 months', 'timeFrame': 'change from baseline in 3-item version of the Utrecht Work Engagement Scale at 6 months', 'description': '"At my work, I feel bursting with energy" (vigor); (2) "I am enthusiastic about my job"(dedication);(3)"I am immersed in my work" (absorption)'}, {'measure': 'Change from baseline in Recovery Experiences Questionnaire at 6 months', 'timeFrame': 'change from baseline in Recovery Experiences at 6 months', 'description': 'The Recovery Experience Questionnaire - a Measure for assessing recuperation and unwinding from work'}, {'measure': 'World health organization Health and work performance questionnaire', 'timeFrame': 'change from baseline in work performance at 6 months', 'description': 'World health organization Health and work performance questionnaire'}, {'measure': 'sleep deprivation questions', 'timeFrame': 'change from baseline in sleep deprivation at 6 months', 'description': 'Sleep deprivation is calculated by subtracting hours slept from hours of sleep needed'}, {'measure': 'Frequency of insomnia symptoms', 'timeFrame': 'change from baseline in insomnia symptoms at 6 months', 'description': 'Symptoms of insomnia are difficulties falling asleep, waking up at nights, waking up too early in the morning unable to fall asleep again and feeling of sleep which does not refresh. How often have you had this kind of symptoms during last 3 months?" Answers were given using Likert-scale: 1) Never or less than once a month, 2) less than once a week, 3) 1-2 days a week, 4) 3-5 days a week or 5) daily or almost daily.'}, {'measure': 'nutritional behaviour', 'timeFrame': 'change from baseline in nutritional behaviour at 6 months', 'description': 'number of meals and snacks per day'}, {'measure': 'Alcohol Use Disorders Identification Test Consumption (Audit-C)', 'timeFrame': 'change from baseline in Audit-C at 6 months', 'description': 'the Finnish version of the questionnaire Alcohol Use Disorders Identification Test Consumption 3 questions'}, {'measure': 'physical activity questionnaire', 'timeFrame': 'change from baseline in physical activity at 6 months', 'description': 'frequency in light and brisk physical activities (daily, four to six times a week, two to three times a week, once a week, two to three times a month, and once a month or less often). The duration of one bout of activity was considered separately for light and brisk activities (over 90 minutes, 60 to 90 minutes, 40 to59 minutes, 20 to 39 minutes, less than 20 minutes, and not at all)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microenterpreneur', 'work ability', 'work recovery', 'native mobile app', 'health behaviour', 'work', 'stress', 'work performance'], 'conditions': ['Work Ability', 'Work-Related Condition', 'Health Behavior', 'Intervention']}, 'referencesModule': {'references': [{'pmid': '37358883', 'type': 'DERIVED', 'citation': 'Kekkonen M, Korkiakangas E, Laitinen J, Oinas-Kukkonen H. Factors Reducing the Use of a Persuasive mHealth App and How to Mitigate Them: Thematic Analysis. JMIR Hum Factors. 2023 Jun 26;10:e40579. doi: 10.2196/40579.'}]}, 'descriptionModule': {'briefSummary': 'A randomized intervention study to promote work recovery and work ability among micro-entrepreneurs. The main aim is to investigate if the use of Recovery! -application results in better work recovery and work ability than no treatment for micro-entrepreneurs.\n\nThe plan of action of the study merges: 1) the contents that are based on the needs of the target population and evidence from research on work related and health behaviour enhancing work recovery, 2) theoretical framework for the counselling, 3) counselling methods including behaviour change techniques, and 4) tailoring the content and counselling according to trans theoretical change model and physical work demands. The intervention is delivered through native mobile application designed by using the abovementioned methodology.\n\nData are collected by repeated internet-based questionnaires (at baseline, 2 and 6 months from the beginning of the intervention) and from the use of mobile application. Furthermore, randomly selected persons in two groups (20-30 persons in each) are interviewed. Process evaluation is conducted to detect the mechanisms of change and to study why the program succeeded or failed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Finnish-speaking micro-entrepreneurs (those with enterprise of 1-9 employees),\n* company is located in Finland.\n* work full-time as entrepreneurs,\n* understand Finnish,\n* use an Android phone.\n\nExclusion Criteria:\n\n* not full-time entrepreneurs\n* on sick leave\n* absent from work'}, 'identificationModule': {'nctId': 'NCT03648593', 'acronym': 'Promo@Work', 'briefTitle': 'Promo@Work Entrepreneurs', 'organization': {'class': 'OTHER', 'fullName': 'Finnish Institute of Occupational Health'}, 'officialTitle': 'The Effects of Counselling Delivered Through Native Mobile Application on Work Ability and Work Recovery Among Micro-entrepreneurs', 'orgStudyIdInfo': {'id': '3522101'}, 'secondaryIdInfos': [{'id': '303430', 'type': 'OTHER_GRANT', 'domain': 'Strategic Research Council at the Academy of Finland'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'behavioral', 'description': 'work recovery intervention', 'interventionNames': ['Behavioral: work recovery intervention']}, {'type': 'EXPERIMENTAL', 'label': 'waiting list control', 'description': 'work recovery intervention after 6 months', 'interventionNames': ['Behavioral: waiting list control']}], 'interventions': [{'name': 'work recovery intervention', 'type': 'BEHAVIORAL', 'description': 'Recover! app: one hour weekly for two months', 'armGroupLabels': ['behavioral']}, {'name': 'waiting list control', 'type': 'BEHAVIORAL', 'description': 'no treatment during 6 months,then Recover! app', 'armGroupLabels': ['waiting list control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Finnish Institute of Occupational Health', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}], 'overallOfficials': [{'name': 'Jaana Laitinen, PhD, Docent', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Specialist'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Finnish Institute of Occupational Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oulu', 'class': 'OTHER'}, {'name': 'Tampere University', 'class': 'OTHER'}, {'name': 'University Hospital of Cologne', 'class': 'OTHER'}, {'name': 'Academy of Finland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Specialist, Principal Investigator, PhD,', 'investigatorFullName': 'Jaana Laitinen', 'investigatorAffiliation': 'Finnish Institute of Occupational Health'}}}}