Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-05 @ 5:47 PM
Study NCT ID:
NCT05401968
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Osteoporosis Patient Education in Denmark
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The municipalities recruit and include citizens in osteoporosis patient education. We have already received information on participants from 2016 until 2020, and thereafter we will create a matched control group, who have not participated in osteoporosis patient education.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3132}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-05-27', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in quality of life between intervention and control group', 'timeFrame': 'At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)', 'description': 'Measured with the 12-item Short-Form Health Survey of the Medical Outcomes Study (SF-12)'}, {'measure': 'Differences in clinical diagnosis of fracture between intervention and control group', 'timeFrame': 'At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)', 'description': 'Including hip, vertebral, forearm, and upper arm fractures registered in the National Patient Register'}], 'secondaryOutcomes': [{'measure': 'Differences in daily functional capacity between intervention and control group', 'timeFrame': 'At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)', 'description': 'Measured with questions from the European Health Interview Survey'}, {'measure': 'Differences in self-efficacy between intervention and control group', 'timeFrame': 'At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)', 'description': 'Measured with the questionnaire Self-Efficacy for Managing Chronic Disease 6-Item Scale (SES6G)'}, {'measure': 'Differences in psychological well-being between intervention and control group', 'timeFrame': 'At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)', 'description': 'Measured with the questionnaire Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)'}, {'measure': 'Differences in physical function between intervention and control group', 'timeFrame': 'At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)', 'description': 'Measured with questions from The Danish National Health Survey'}, {'measure': 'Differences in balance between intervention and control group', 'timeFrame': 'At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)', 'description': 'Measured with self-constructed, validated questions regarding problems with balance and balance confidence'}, {'measure': 'Differences in falls between intervention and control group', 'timeFrame': 'At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)', 'description': 'Measured with self-constructed, validated questions regarding number of falls and concerns about falling'}, {'measure': 'Differences in pain management between intervention and control group', 'timeFrame': 'At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)', 'description': 'Measured with the Pain Self-Efficacy Questionnaire (PSEQ)'}, {'measure': 'Differences in adherence by Medication Possession Ratio (MPR) between intervention and control group', 'timeFrame': 'At follow-up (1 to 6 years after the index date i.e. the date the individual in the intervention group started on patient education)', 'description': 'Including adherence to alendronate and ibandronate attained from the Danish National Prescription Registry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient education'], 'conditions': ['Osteoporosis']}, 'descriptionModule': {'briefSummary': 'In an effect evaluation the investigators will examine the effects of participating in osteoporosis patient education. An intervention group who have already participated in patient education will be compared to a matched control group who have not participated. Effects on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence will be examined.', 'detailedDescription': 'In this quasi-experimental study the investigators will conduct an effect evaluation that compares an intervention group of osteoporosis patients who have participated in patient education in a municipality with a control group who have not participated.\n\nThe intervention group consists of citizens who have already participated in osteoporosis patient education from 2016 until 2020. The investigators have received information on the intervention group from the municipalities who store data on previous participants.\n\nThe control group will be extracted via the Danish Health Data Authority and consists of citizens who have not participated in osteoporosis patient education. For each individual in the intervention group one control will be matched regarding gender, age, diagnosis, time of diagnose, and type of fracture before the index date (i.e. the date the individual in the intervention group started on patient education).\n\nThe aim of the effect evaluation is to examine the effects of osteoporosis patient education on quality of life, fractures, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, pain management, and adherence.\n\nData is generated from a register extraction and a questionnaire-based survey. The questionnaire will include information on quality of life, daily functional capacity, self-efficacy, psychological wellbeing, physical function, balance, falls, and pain management. As far as possible validated questionnaires will be included to measure these outcomes. The register extraction will be made by the Danish Health Data Authority and include information on fractures and adherence.\n\nAll analyses are performed using Stata. In the analyses the investigators will compare the intervention group and the control group with regard to all outcomes. The covariates are selected on the basis of Directed Acyclic Graphs (DAG) and they include e.g. socioeconomic status, cohabitee status, and co-morbidity. The analysis will be completed on an intention to treat basis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To participate in osteoporosis patient education in municipalities the participants should have osteoporosis or in few cases osteopenia.\n\nExclusion Criteria:\n\n* None though this may vary across municipalities'}, 'identificationModule': {'nctId': 'NCT05401968', 'briefTitle': 'Osteoporosis Patient Education in Denmark', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Osteoporosis Patient Education in Danish Municipalities: an Evaluation of Existing Programs and Recommendations for Further Practice', 'orgStudyIdInfo': {'id': '19/33410'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Osteoporosis patients who have participated in patient education', 'interventionNames': ['Behavioral: Osteoporosis patient education']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Osteoporosis patients who have not participated in patient education'}], 'interventions': [{'name': 'Osteoporosis patient education', 'type': 'BEHAVIORAL', 'description': 'During osteoporosis patient education the participants get knowledge about e.g. osteoporosis, medication, and diet, and they participate in physical exercises. Though, differences between municipalities exist. The participants meet in groups and face-to-face.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'National Institute of Public Health, University of Southern Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Holmberg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}, {'name': 'Andersen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}, {'name': 'Hitz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Center for Bone Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'If possible, we will store data at The Danish National Archives. We will apply for storing at a later date.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Center for Bone Health', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}