Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-02-20 @ 1:45 PM
Study NCT ID:
NCT02445950
Status:
COMPLETED
Last Update Posted:
2016-04-26
First Post:
2015-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
With-Me - Technology-Aided Phone Coaching for Occupational Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D003258', 'term': 'Consumer Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-25', 'studyFirstSubmitDate': '2015-05-06', 'studyFirstSubmitQcDate': '2015-05-12', 'lastUpdatePostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time used for coaching', 'timeFrame': '6 months', 'description': "Measured by the coaches' working time dedicated to coaching from manual logs and Movendos log. This is used to evaluate the cost of coaching."}, {'measure': 'Psychological wellbeing', 'timeFrame': '6 months', 'description': 'Measured by the Työoptimi occupational health questionnaire. This is used to evaluate the effectiveness of the coaching.'}], 'secondaryOutcomes': [{'measure': 'Customer satisfaction for coaching', 'timeFrame': '6 months', 'description': 'Measured by ad hoc questionnaires.'}, {'measure': 'Occupational health', 'timeFrame': '6 months', 'description': 'Measured by Työoptimi occupational health questionnaire.'}, {'measure': 'Satisfaction to life situation', 'timeFrame': '6 months', 'description': 'Measured by scale from 1 to 5.'}, {'measure': 'Self-esteem', 'timeFrame': '6 months', 'description': "Measured by 10-item Rosenberg's Self-Esteem Scale."}, {'measure': 'Cognitive fusion', 'timeFrame': '6 months', 'description': 'Measured by 7-item Cognitive Fusion Questionnaire'}, {'measure': 'Perceived stress', 'timeFrame': '6 months', 'description': 'Measured by a single-item stress scale.'}, {'measure': 'Satisfaction to a relationship', 'timeFrame': '6 months', 'description': "The scale is modified from The Family Federation of Finland's quality test of a relationship."}, {'measure': 'Activeness in conducting tasks', 'timeFrame': '6 months', 'description': 'Self-assessment measured via phone interviews and questionnaires.'}, {'measure': 'Carefulness in conducting tasks', 'timeFrame': '6 months', 'description': 'Self-assessment measured via phone interviews and questionnaires.'}, {'measure': 'Readiness to change', 'timeFrame': '6 months', 'description': 'Readiness to change scale measured by questionnaire based on Transtheoretical Model (Stages of Change).'}, {'measure': 'Lifestyle', 'timeFrame': '6 months', 'description': 'Evaluated by ad hoc questionnaire on amount of sleep, alcohol consumption and smoking, and eating habits.'}, {'measure': 'Number of the changes made to the profile', 'timeFrame': '1 month', 'description': 'Data from the profiling database.'}, {'measure': 'Perceived Accuracy of the profiling tool', 'timeFrame': '1 month', 'description': 'Assessed by the coaches via questionnaires.'}, {'measure': 'Perceived ease of use', 'timeFrame': '6 months', 'description': 'Measured by questionnaires to customers, questionnaires and interview to coaches.'}, {'measure': 'Perceived usefulness', 'timeFrame': '6 months', 'description': 'Measured by the questionnaires to customers, questionnaires and interview to coaches.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Coaching', 'Well-being', 'Digital Health', 'Profiling', 'Customer Satisfaction', 'User Experience', 'Occupational Health', 'Lifestyle', 'Psychological Stress', 'Cost-Effectiveness', 'Guideline Adherence'], 'conditions': ['Psychological Stress']}, 'referencesModule': {'references': [{'pmid': '35830233', 'type': 'DERIVED', 'citation': 'Muuraiskangas ST, Honka AM, Junno UM, Nieminen HO, Kaartinen JK. A Technology-Assisted Telephone Intervention for Work-Related Stress Management: Pilot Randomized Controlled Trial. J Med Internet Res. 2022 Jul 13;24(7):e26569. doi: 10.2196/26569.'}], 'seeAlsoLinks': [{'url': 'http://www.with-me-project.eu/', 'label': 'Project website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine whether the technology (web-based coaching, profiling and suggestion tool) brings added value to the traditional phone coaching in occupational health context. The interventions are phone counseling interventions. The other intervention exploits additionally a specific web-based coaching, profiling and suggestion tool.', 'detailedDescription': 'The study focuses on mental well-being. The both interventions include intensive and independent phase.\n\nThe intensive phase lasts 13 weeks. In the intensive phase, goals for the coaching are defined. Coach calls the customer every two weeks and they discuss about the actions that took place in the previous two weeks and what they need to do in the next two weeks. In the technology-aided arm, customers get and analysis of their change needs via digital tool. Based on the change needs they receive task/goal suggestions from which they need to choose 3. Coach is able to see these choices and exploits it in the coaching. The selected behavioral activation interventions are delivered to customer utilizing a web-based coaching tool.\n\nThe independent phase lasts 13 weeks. In the independent phase, technology-aided group is coached via the digital tool. The phone counseling group gets 3 phone calls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least a bachelor level degree\n* Age over 18 years\n* Decreased psycho-physic state (own assessment)\n* Is in a relationship\n* Motivated to enhance own well-being and willing to change lifestyle, to do exercises related on mental well-being and relationship\n* Willing to use technological wellness coaching tools, familiarity with technology\n\nExclusion Criteria:\n\n* Work includes night shifts\n* Acute health conditions or serious diseases\n* Chronical pain affecting functionality\n* Long period(s) of absence from work during the coaching period (e.g. long vacation, alternation leave, parental leave, pension)\n* Participation in some other study'}, 'identificationModule': {'nctId': 'NCT02445950', 'briefTitle': 'With-Me - Technology-Aided Phone Coaching for Occupational Health Study', 'organization': {'class': 'OTHER', 'fullName': 'VTT Technical Research Centre of Finland'}, 'officialTitle': 'With-Me - Technology-Aided Phone Coaching for Occupational Health Study', 'orgStudyIdInfo': {'id': '332885 With-Me-Occ'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Technology-aided counseling', 'description': 'Customers receive intervention via technology-aided phone wellness counseling. The intensive phase lasts 13 weeks and includes 5 phone calls. The customers are able to view their change change needs and choose tasks/goals for the coaching. The independent phase lasts 13 weeks and coaching is done via a digital tool.', 'interventionNames': ['Behavioral: Technology-aided phone wellness counselling']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional counseling', 'description': 'Customers receive intervention via traditional phone wellness counseling. The intensive phase lasts 13 weeks and includes 5 phone calls. Change needs and goals are set during the phone calls. The independent phase lasts 13 weeks and includes 3 phone calls.', 'interventionNames': ['Behavioral: Phone wellness counselling']}], 'interventions': [{'name': 'Technology-aided phone wellness counselling', 'type': 'BEHAVIORAL', 'description': 'The intervention provides phone wellness counselling with the help of web-based interventions, digital profiling and suggestion tool in occupational health.', 'armGroupLabels': ['Technology-aided counseling']}, {'name': 'Phone wellness counselling', 'type': 'BEHAVIORAL', 'description': 'The intervention provides phone wellness counseling in occupational health.', 'armGroupLabels': ['Traditional counseling']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Hannu Nieminen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Technical University of Denmark'}, {'name': 'Jouni Kaartinen, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VTT Technical Research Centre of Finland Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VTT Technical Research Centre of Finland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Firstbeat Technologies Ltd.', 'class': 'INDUSTRY'}, {'name': 'Mawell Care Ltd', 'class': 'UNKNOWN'}, {'name': 'Mawell Ltd', 'class': 'UNKNOWN'}, {'name': 'Oulun Työterveys', 'class': 'UNKNOWN'}, {'name': 'Technical University of Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}