Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-01-12 @ 10:37 AM
Study NCT ID:
NCT01925105
Status:
UNKNOWN
Last Update Posted:
2015-09-15
First Post:
2013-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comprehensive Geriatric Assessment - Can it Improve Quality of Life
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-14', 'studyFirstSubmitDate': '2013-08-13', 'studyFirstSubmitQcDate': '2013-08-15', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The quality of drug treatment', 'timeFrame': '1 year from baseline'}], 'primaryOutcomes': [{'measure': 'Retained or increased quality of life of at least 20% measured by EQ-5D (EuroQOL) after 1 year from baseline.', 'timeFrame': '1 year from baseline'}], 'secondaryOutcomes': [{'measure': 'Readmission to hospital', 'timeFrame': '1 year from baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Polypharmacy'], 'conditions': ['Quality of Life']}, 'descriptionModule': {'briefSummary': "Like most developed countries the population of Sweden is getting older and consequently the number of individuals with chronic diseases will be an increasing challenge for its healthcare system. To improve care of the frail elderly, wards with a coordinated multidisciplinary team and multidisciplinary mobile teams were established several years ago. Treatment and follow up is planned in accordance to the patients' medical, psychological and functional capabilities (Comprehensive Geriatric Assessment = CGA). There are to our knowledge only few studies concerning CGA applicable to Swedish conditions. We plan to conduct a Swedish study that evaluates if care and treatment with a modified CGA-model in an outpatient setting can improve quality of life for frail older people."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥65 years\n* Live in own home\n* Reason to believe that the health condition is not optimal or could be optimized\n* Meet at least 2/6 of the following criteria: cognitive impairment, general tiredness or dyspnea, have fallen often/afraid to fall, need help with activities of daily living, hospital care ≥3 times within the last 12 months, care problems at home\n\nExclusion Criteria:\n\n* Psychosis\n* Not understand the Swedish language'}, 'identificationModule': {'nctId': 'NCT01925105', 'briefTitle': 'Comprehensive Geriatric Assessment - Can it Improve Quality of Life', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Örebro County Council'}, 'officialTitle': 'Comprehensive Geriatric Assessment - Can it Improve Quality of Life', 'orgStudyIdInfo': {'id': 'AFC-162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optimization of treatment', 'description': 'Optimization of treatment of diseases and symptoms', 'interventionNames': ['Other: Experimental: Optimization of treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Treatment as usual'}], 'interventions': [{'name': 'Experimental: Optimization of treatment', 'type': 'OTHER', 'description': 'Optimization of treatment of diseases and symptoms', 'armGroupLabels': ['Optimization of treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70116', 'city': 'Örebro', 'state': 'Örebro County', 'country': 'Sweden', 'facility': 'Örebro County Council', 'geoPoint': {'lat': 59.27412, 'lon': 15.2066}}], 'overallOfficials': [{'name': 'Peter Engfeldt, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Allmänmedicinskt forskningscentrum, AFC, Örebro läns landsting, Box 1613, 70116 Örebro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro County Council', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Anna Engfeldt', 'investigatorAffiliation': 'Örebro County Council'}}}}