Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-31 @ 11:38 AM
Study NCT ID:
NCT01585493
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2012-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHANGE -it is About Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D012907', 'term': 'Smoking'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-26', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-04-23', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Positive and negative symptoms', 'timeFrame': '12 months'}, {'measure': 'Cognition', 'timeFrame': '12 months'}, {'measure': 'Quality of life', 'timeFrame': '12 months'}, {'measure': 'Dietary pattern', 'timeFrame': '12 months'}, {'measure': 'Self rated health', 'timeFrame': '12 months'}, {'measure': 'High sensitive CRP', 'timeFrame': '12 months'}, {'measure': 'Triglycerides', 'timeFrame': '12 months'}, {'measure': 'Global assessment functioning (GAF)', 'timeFrame': '12 months'}], 'primaryOutcomes': [{'measure': 'Copenhagen Risk Score', 'timeFrame': '12 months', 'description': 'The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.'}], 'secondaryOutcomes': [{'measure': 'Smoking', 'timeFrame': '12 months', 'description': 'Number of daily smokers in each group at 12 months'}, {'measure': 'Sedentary lifestyle', 'timeFrame': '12', 'description': 'Self reported hours of sedentary behavior'}, {'measure': 'Body mass index', 'timeFrame': '12 months', 'description': 'Change in body mass index at 12 months'}, {'measure': 'Blood pressure', 'timeFrame': '12 months', 'description': 'Change in systolic and diastolic blood pressure at 12 months'}, {'measure': 'Cholesterol', 'timeFrame': '12 months', 'description': 'Change in total Cholesterol, LDL, HDL, and triglycerides and 12 months'}, {'measure': 'Aerobic fitness', 'timeFrame': '12 months', 'description': 'Indirectly estimated maximal oxygen uptake'}, {'measure': 'Waist circumference', 'timeFrame': '12 months', 'description': 'Measured between crista iliaca and the lowest rib'}, {'measure': 'Forced expiratory volume', 'timeFrame': '12 months'}, {'measure': 'Resting heart rate', 'timeFrame': '12 months'}, {'measure': 'HbA1c', 'timeFrame': '12 months'}, {'measure': 'Physical activity', 'timeFrame': '12 months', 'description': 'Change in minutes of MVPA a week'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lifestyle', 'Smoking', 'Dietary', 'Exercise'], 'conditions': ['Schizophrenia', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '26001844', 'type': 'DERIVED', 'citation': 'Speyer H, Norgaard HC, Hjorthoj C, Madsen TA, Drivsholm S, Pisinger C, Gluud C, Mors O, Krogh J, Nordentoft M. Protocol for CHANGE: a randomized clinical trial assessing lifestyle coaching plus care coordination versus care coordination alone versus treatment as usual to reduce risks of cardiovascular disease in adults with schizophrenia and abdominal obesity. BMC Psychiatry. 2015 May 23;15:119. doi: 10.1186/s12888-015-0465-2.'}]}, 'descriptionModule': {'briefSummary': 'Schizophrenia is a life shortening disease, not only because of suicide but also because of increased mortality from natural causes. Recently, a large register-based study, involving complete national data from Denmark, Sweden and Finland, showed that life expectancy for schizophrenia is 20 years shorter for men and 15 years shorter for women, compared to the general population, and that mortality from medical conditions and diseases are responsible for a large proportion of the reduced life expectancy. Patients with schizophrenia had a twofold to fivefold increased risk of death by coronary heart disease, respiratory diseases, lung cancer and metabolic conditions. Unhealthy life style and undetected and untreated physical disorders play an important role in this excess mortality.Results from the Danish National Indicator Project for Schizophrenia showed that a much higher proportion of patients with schizophrenia compared to the general population have measures of waist circumference, body mass index, blood pressure, blood lipids and blood glucoses above the recommended upper values.\n\nIn the randomized clinical trial CHANGE, the investigators will evaluate the effect of two different interventions both aiming to reduce risk for death from medical diseases. We will compare 1) treatment as usual with 2) affiliation to a care coordinator who has the duty to connect the patient to general practice and primary care and 3) affiliation to a staff member from the CHANGE team who should facilitate life style changes and contact with general practice. The objective is to identify interventions that can reduce the risk of early death in patients with schizophrenia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Affiliated to outpatients services at Mental Health Centre, Copenhagen or Århus University Hospital\n* Diagnose ICD-10:F2 spectrum\n* Waist circumference \\> 88 cm for women or \\>102 cm for men\n\nExclusion Criteria:\n\n* Not willing to participate'}, 'identificationModule': {'nctId': 'NCT01585493', 'briefTitle': 'CHANGE -it is About Life', 'organization': {'class': 'OTHER', 'fullName': 'Mental Health Services in the Capital Region, Denmark'}, 'officialTitle': 'CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia', 'orgStudyIdInfo': {'id': 'Change'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Treatment as usual', 'interventionNames': ['Other: Treatment as usual']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Care coordinator', 'interventionNames': ['Behavioral: Care coordinator']}, {'type': 'EXPERIMENTAL', 'label': 'CHANGE', 'interventionNames': ['Behavioral: CHANGE']}], 'interventions': [{'name': 'Treatment as usual', 'type': 'OTHER', 'description': 'Treatment as usual. Patients will be affiliated with local out-patient clinics in secondary mental health services and they will have access to their own general practitioner. No formalized extra effort will be made to ensure treatment of physical disorders.Patients will be affiliated with local out-patient clinics in secondary', 'armGroupLabels': ['Treatment as usual']}, {'name': 'Care coordinator', 'type': 'BEHAVIORAL', 'description': 'Treatment as usual plus a care coordinator (with a caseload of 25 patients) who will facilitate contact to primary care in order to ensure treatment of physical health problems,', 'armGroupLabels': ['Care coordinator']}, {'name': 'CHANGE', 'type': 'BEHAVIORAL', 'description': "Treatment as usual plus affiliation to a staffmember (caseload 10) from a CHANGE team who will provide individualized, adjusted implementation of widely recognized interventions, such as smoking cessation programmes, motivational interviewing, psychoeducation plus patient involvement in monitoring health statusA multidisciplinary CHANGE team will be established. Team members will be health professionals with experience in smoking cessation programmes or exercise programmes for mentally ill, and experts with competence in dietary issues.\n\nCHANGE treatment involve lifestyle coaching, education about diet and physical activity,16 networking and smoking cessation programs. The team members will act as lifestyle coaches for ten patients at a time, map lifestyle and explore and elicit patients' motivation for change.", 'armGroupLabels': ['CHANGE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Mental Health Services in the Capital Region, Denmark', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Merete Nordentoft, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mental Health Services in the Capital Region, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mental Health Services in the Capital Region, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}