Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-06-14 @ 2:03 AM
Study NCT ID:
NCT02457533
Status:
UNKNOWN
Last Update Posted:
2015-05-29
First Post:
2015-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Case Management - Active Telephone Support to Patients With COLD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2015-04-23', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life questionnaire SF-36 (Short-Form Health Survey)', 'timeFrame': 'Participants will be followed an expected avarage of 6 months'}], 'secondaryOutcomes': [{'measure': 'Analysis of patients use of Health Care system', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['COLD']}, 'descriptionModule': {'briefSummary': 'To investigate the effects of patient counseling by telephone on Quality of Life and the use of Health care system.', 'detailedDescription': 'By analyzing patient data, patients with risk of high consumption of the Health system are identified.\n\nThese patients are invited to take part in the study. If the patient accept the invitation, oral and written information of the study is given. If the patient give informed consent to participate, the inclusion and exclusion criteria and the patient record are examined.\n\nIf the patient meet the criteria the patient is randomized to active treatment or control 1:1.\n\nPatient in the Intervention Group have a in depth interview of Health and social status and possible interventions are planned. Following that, the patient is contacted by telephone on weekly intervals for 6 to 9 months.\n\nPatients in both Groups fill out questionaire Short-Form Health Survey-36 (SF-36) and COPD Assessment Test (COPD) and the consumption of Health care is monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient living in The Zealand Region.\n* A COLD-related contact with hospital with-in 6 months.\n* Predicted to be in high risk of new hospital admission.\n\nExclusion Criteria:\n\n* Dementia.\n* Psychosis.\n* Drug-addiction.\n* Cancer with metastasis.\n* Terminal illness.\n* Language difficulties demanding translator.'}, 'identificationModule': {'nctId': 'NCT02457533', 'briefTitle': 'Case Management - Active Telephone Support to Patients With COLD', 'organization': {'class': 'OTHER', 'fullName': 'Region Sjælland'}, 'officialTitle': 'Active Support to Patient With COLD', 'orgStudyIdInfo': {'id': 'CM1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Only SF-36 and CAT'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Lifestyle behavioral. Health plan, telephone support', 'interventionNames': ['Behavioral: Lifestyle behavioral. Health plan, telephone support']}], 'interventions': [{'name': 'Lifestyle behavioral. Health plan, telephone support', 'type': 'BEHAVIORAL', 'description': "'Lifestyle behavioral. Health plan, telephone support'", 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Knud Rasmussen, MD DMSci', 'role': 'CONTACT', 'email': 'kra@regionsjaelland.dk', 'phone': '+45 60168891'}], 'facility': 'Regional Research', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'centralContacts': [{'name': 'Knud Rasmussen, MD DMSci', 'role': 'CONTACT', 'email': 'kra@regionsjaelland.dk', 'phone': '+45 60168891'}, {'name': 'Mahad Huniche, Director', 'role': 'CONTACT', 'email': 'mahu@regionsjaelland.dk', 'phone': '+45 51200187'}], 'overallOfficials': [{'name': 'Knud Rasmussen, MD DMSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region of Zealand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Sjælland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Navigator, Sweden', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}