Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT00235404
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2005-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Health Care to Elderly Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2005-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2005-10-07', 'studyFirstSubmitQcDate': '2005-10-07', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of readmissions', 'timeFrame': 'Within 60 days'}, {'measure': 'Number of deaths', 'timeFrame': 'Within 12 months'}, {'measure': 'Need of home nursing services', 'timeFrame': 'within 12 months'}], 'secondaryOutcomes': [{'measure': 'Costs', 'timeFrame': 'Within 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Treatment of elderly.', 'Nursing home.', 'Rehabilitation.', 'Readmissions.'], 'conditions': ['Congestive Heart Failure', 'Angina Pectoris', 'Asthma', 'Pneumonia', 'Fractures']}, 'referencesModule': {'references': [{'pmid': '17475006', 'type': 'RESULT', 'citation': 'Garasen H, Windspoll R, Johnsen R. Intermediate care at a community hospital as an alternative to prolonged general hospital care for elderly patients: a randomised controlled trial. BMC Public Health. 2007 May 2;7:68. doi: 10.1186/1471-2458-7-68.'}, {'pmid': '18264150', 'type': 'RESULT', 'citation': 'Garasen H, Magnussen J, Windspoll R, Johnsen R. [Elderly patients in hospital or in an intermediate nursing home department--cost analysis]. Tidsskr Nor Laegeforen. 2008 Jan 31;128(3):283-5. Norwegian.'}, {'pmid': '18519285', 'type': 'RESULT', 'citation': "Garasen H, Windspoll R, Johnsen R. Long-term patients' outcomes after intermediate care at a community hospital for elderly patients: 12-month follow-up of a randomized controlled trial. Scand J Public Health. 2008 Mar;36(2):197-204. doi: 10.1177/1403494808089685."}]}, 'descriptionModule': {'briefSummary': 'To study the efficacy of multicomponent treatment and care for patients with acute illness or deterioration of a chronic disease at a nursing home in primary health care compared to traditional treatment at hospital.', 'detailedDescription': 'Managers at St. Olavs University Hospital and the City of Trondheim local authority decided in 2001 to establish a reinforced department at a nursing home with a multicomponent approach to patient treatment.\n\nIn the study treatment at a nursing home will be compared with conventional treatment in ordinary hospital beds in medical, surgical and orthopedic departments at a hospital. Participating doctors at the hospital together with general practitioners shall develope inclusion criteria through Delphi technique. Eligible participants will be hospitalized from their ordinary home and expected to return to home after treatment. When an eligible patient is identified and accepted for inclusion, randomization will be performed by the Clinical Research Department at the Faculty of Medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participating doctors at the hospital together with general practitioners shall develope inclusion criteria through Delphi technique.\n\nExclusion Criteria:\n\n* Participating doctors at the hospital together with general practitioners shall develope exclusion criteria through Delphi technique.'}, 'identificationModule': {'nctId': 'NCT00235404', 'briefTitle': 'Randomized Controlled Trial of Health Care to Elderly Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Specialized Treatment and Care Intervention at a Primary Level in a Nursing Home Compared to Conventional Treatment at a Hospital: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'REK 037-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intermediate community hospital', 'interventionNames': ['Other: Multicomponent treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual care', 'interventionNames': ['Other: usual care']}], 'interventions': [{'name': 'Multicomponent treatment', 'type': 'OTHER', 'description': 'Specialized care in preparing recharge to home', 'armGroupLabels': ['Intermediate community hospital']}, {'name': 'usual care', 'type': 'OTHER', 'description': 'Usual recharge directly from hospital to home', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7489', 'city': 'Trondheim', 'country': 'Norway', 'facility': 'Faculty of Medicine, The Norwegian University of Science and Technology (NTNU)', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Roar Johnsen', 'role': 'STUDY_CHAIR', 'affiliation': 'The Norwegian University of Science and Technology (NTNU)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Helse Nord-Trøndelag HF', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}