Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-28 @ 9:26 PM
Study NCT ID:
NCT04177459
Status:
TERMINATED
Last Update Posted:
2020-06-25
First Post:
2019-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation of Adolescents Living With Chronic Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015673', 'term': 'Fatigue Syndrome, Chronic'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D004679', 'term': 'Encephalomyelitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Covid-19', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-23', 'studyFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2019-11-22', 'lastUpdatePostDateStruct': {'date': '2020-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Health-related quality of life (HRQoL)', 'timeFrame': '1 year', 'description': 'assessed by PedsQL Generic Core scale 4.0'}], 'secondaryOutcomes': [{'measure': 'Fatigue Questionnaire', 'timeFrame': '1 year', 'description': 'PedsQL Multidimensional Fatigue Questionnaire'}, {'measure': 'Mood and Feelings Questionnaire', 'timeFrame': '1 year', 'description': 'Short Mood and Feelings Questionnaire'}, {'measure': 'Self-reported follow-up, School functioning and participation in Leisure activities', 'timeFrame': '1 year', 'description': 'Self-report form with yes/no answers regarding follow-up from health care personnel, follow-up from school, school attendance and participation in leisure activities.'}, {'measure': 'EQ-5D-5L', 'timeFrame': '1 year', 'description': 'EQ-5D-5L is a 5 dimension and 5 level Questionnaire from the Euro Qol Group (supported by the Euro QolGroup Association and Euro Qol Research Foundation). Health states which is defined by EQ-5D-5L-answers, is assigned a score between 0 and 1 by applying preference weights. In Norway it has been common to use preference weights obtained from a sample of the general population in the UK. Norwegian preference weights will be available in near future. EQ-5D is the name of the instrument and is not an acronym. EQ-5D is the correct term to use in print or verbally.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adolescent', 'Fatigue', 'Rehabilitation', 'Health Promotion', 'Health-related Quality of Life', 'Sense of Coherence', 'Emotions', 'Mood', 'Leisure Activities'], 'conditions': ['Fatigue Syndrome, Chronic']}, 'descriptionModule': {'briefSummary': 'Previous studies have shown that health-related quality of life (HRQoL) in adolescents living with chronic fatigue syndrome (CFS/ME) is low if compared with healthy adolescents and adolescents living with other chronic diseases. Effective strategies to improve HRQoL in this group are still lacking. Recently we have observed HRQoL in a group of Norwegian adolescents with CFS/ME (not yet published), which is the background for a new study where we have planned an intervention with health promoting dialogues between patient and nurse, as a strategy to improve HRQoL. In this study we have also opened to include adolescents with other chronic fatigue diagnosis with similar challenges in follow-up as in CFS/ME.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* chronic fatigue as main symptom (including but not limited to diagnostic codes ICD-10 G93.3 CFS/ME, F48.0 Neurasthenia, R53 Fatigue)\n* having undergone an interdisciplinary diagnostic evaluation at The Children's Clinic or at The Fatigue and CFS/ME Outpatient Clinic, St. Olavs hospital during the period 1.8.2019 - 1.4.2020.\n* being a pupil or wishing to be a pupil.\n\nExclusion Criteria:\n\n* not Norwegian speaking\n* for any reason unable to read and answer a questionnaire\n* for any reason unable to take part in the health promoting dialogues"}, 'identificationModule': {'nctId': 'NCT04177459', 'briefTitle': 'Rehabilitation of Adolescents Living With Chronic Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Rehabilitation of Adolescents Living With Chronic Fatigue. Health and Quality of Life During the Disease, and How to Remain in School and Spare-time Activities. Testing of a Structured Home-based Rehabilitation Program.', 'orgStudyIdInfo': {'id': '2019/1081'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Health promoting dialogue in addition to treatment as usual', 'description': 'Health promoting dialogues in addition to follow-up from primary and secondary health care, and from schools, which is individually customized due to fatigue and other symptoms present.', 'interventionNames': ['Behavioral: Health promoting dialogue', 'Other: standard treatment / treatment as usual']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Follow-up from primary and secondary health care, and from Schools, which is individually customized due to fatigue and other symptoms present..', 'interventionNames': ['Other: standard treatment / treatment as usual']}], 'interventions': [{'name': 'Health promoting dialogue', 'type': 'BEHAVIORAL', 'description': 'Health promoting dialogues based on the salutogenic theory, focusing on resources within and around the individual, and on coping strategies. Seven individual dialogues for each participant, individually adapted due to the fatigue. The intervention is offered in the participants home or at the local hospital, dependent on the participants fatigue and what is preferred.', 'armGroupLabels': ['Health promoting dialogue in addition to treatment as usual']}, {'name': 'standard treatment / treatment as usual', 'type': 'OTHER', 'description': 'Follow-up from primary and secondary health care, and from schools.', 'armGroupLabels': ['Health promoting dialogue in addition to treatment as usual', 'Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Trondheim', 'country': 'Norway', 'facility': "Barne og ungdomsklinikken (Children's Clinic)", 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Elisabeth Selvaag, md phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St. Olavs Hospital'}, {'name': 'Torstein Baade Rø, md phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The standard consent form used in this study is developed by the regional ethical committee, and does not include consent to make individual participant data available for other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, {'name': 'Trondheim Kommune', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}