Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-04-05 @ 3:22 PM
Study NCT ID:
NCT02641704
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2015-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Development Path
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2015-12-22', 'studyFirstSubmitQcDate': '2015-12-22', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Well-being', 'timeFrame': '12 months', 'description': 'World Health Organization-5'}], 'secondaryOutcomes': [{'measure': 'Well-being', 'timeFrame': '24 months', 'description': 'World Health Organization-5'}, {'measure': 'Work ability', 'timeFrame': '12 months', 'description': '10-points Likert scale'}, {'measure': 'Work ability', 'timeFrame': '24 months', 'description': '10-points Likert scale'}, {'measure': 'Pain', 'timeFrame': '12 months', 'description': 'Visual analogue scale'}, {'measure': 'Pain', 'timeFrame': '24 months', 'description': 'Visual analogue scale'}, {'measure': 'Interpersonal Problems', 'timeFrame': '12 months', 'description': 'Inventory of Interpersonal Problems-64'}, {'measure': 'Interpersonal Problems', 'timeFrame': '24 months', 'description': 'Inventory of Interpersonal Problems-64'}, {'measure': 'Physical capacity', 'timeFrame': '12 months', 'description': '10-points Likert scale, 5 domains'}, {'measure': 'Physical capacity', 'timeFrame': '24 months', 'description': '10-points Likert scale, 5 domains'}, {'measure': 'Kinesiophobia', 'timeFrame': '12 months', 'description': 'Tampa Scale for Kinesiophobia'}, {'measure': 'Kinesiophobia', 'timeFrame': '24 months', 'description': 'Tampa Scale for Kinesiophobia'}, {'measure': 'Self-efficacy', 'timeFrame': '12 months', 'description': 'General Self-efficacy Scale'}, {'measure': 'Self-efficacy', 'timeFrame': '24 months', 'description': 'General Self-efficacy Scale'}, {'measure': 'Depression and anxiety', 'timeFrame': '12 months', 'description': 'Patient Health Questionnaire-4'}, {'measure': 'Depression and anxiety', 'timeFrame': '24 months', 'description': 'Patient Health Questionnaire-4'}, {'measure': 'Loneliness', 'timeFrame': '12 months', 'description': 'Three-item Loneliness Scale'}, {'measure': 'Loneliness', 'timeFrame': '24 months', 'description': 'Three-item Loneliness Scale'}, {'measure': 'Ability to work', 'timeFrame': '12 months', 'description': 'Registerbased'}, {'measure': 'Ability to work', 'timeFrame': '24 months', 'description': 'Registerbased'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Absenteeism']}, 'referencesModule': {'references': [{'pmid': '35392873', 'type': 'DERIVED', 'citation': 'Andersen LN, Stochkendahl MJ, Roessler KK. En route to flourishing - a longitudinal mixed methods study of long-term unemployed citizens in an interdisciplinary rehabilitation program. BMC Public Health. 2022 Apr 7;22(1):675. doi: 10.1186/s12889-022-13060-9.'}, {'pmid': '35255976', 'type': 'DERIVED', 'citation': 'Andersen LN, Stochkendahl MJ, Roessler KK. Parked on the verge: vocational rehabilitation of long-term unemployed citizens - a mixed methods study. Arch Public Health. 2022 Mar 7;80(1):73. doi: 10.1186/s13690-022-00838-x.'}, {'pmid': '29970107', 'type': 'DERIVED', 'citation': 'Andersen LN, Stochkendahl MJ, Roessler KK. A municipality-based vocational rehabilitation programme for occupationally marginalized citizens: a study protocol for a mixed methods study. BMC Health Serv Res. 2018 Jul 3;18(1):517. doi: 10.1186/s12913-018-3322-4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this project is a research-based evaluation of a multidisciplinary program focusing on moving citizens from unemployment and social security benefits to employment and education in Sonderborg Municipality. The citizens who are assigned cannot readily enter the labor market or can get education through employment initiatives in the Job Centre in Sonderborg Municipality because of complex health-related troubles.\n\nThe project is designed to include a prospective observational study and a qualitative study using questionnaires, observations, interviews and informations about employment from the Sonderborg Municipality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Unemployed citizens with complex health-related problems assigned to a multidisciplinary program in Sønderborg Municipality', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Assigned to a multidisciplinary program in Sonderborg Municipality (the Law on Active Employment §68 https://www.retsinformation.dk/forms/r0710.aspx?id=164698#Kap2 )\n\nExclusion Criteria:\n\n* Not able to communicate in Danish'}, 'identificationModule': {'nctId': 'NCT02641704', 'briefTitle': 'The Development Path', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'A Descriptive Study of Characteristics and Progression of Citizens Assigned to a Multidisciplinary Program Focusing on Moving Citizens From Unemployment and Social Security Benefits to Employment and Education', 'orgStudyIdInfo': {'id': '14111-SDUpro'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multidisciplinary program', 'description': 'Multidisciplinary program designed and administered by the Competence- and Integration Center in Sonderborg Municipality', 'interventionNames': ['Behavioral: Multidisciplinary program']}], 'interventions': [{'name': 'Multidisciplinary program', 'type': 'BEHAVIORAL', 'description': 'Coordinated multidisciplinary program', 'armGroupLabels': ['Multidisciplinary program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sønderborg', 'country': 'Denmark', 'facility': 'Sønderborg Municipality', 'geoPoint': {'lat': 54.90896, 'lon': 9.78917}}], 'overallOfficials': [{'name': 'Lotte Nygaard Andersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sonderborg Municipality', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lotte Nygaard Andersen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}