Somatic Disease Among Alcohol Abusers in an Out-day Patients' Clinic
| Tracking Information | |||||
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| First Received Date ICMJE | March 4, 2010 | ||||
| Last Updated Date | May 2, 2013 | ||||
| Start Date ICMJE | March 2010 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Prevalence of different kinds of somatic disease [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: No ] Prevalence of somatic disease at study attendance of any kind, specified for heart disease, gall- and liver disease, neuropathic disease. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01081197 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Somatic Disease Among Alcohol Abusers in an Out-day Patients' Clinic | ||||
| Official Title ICMJE | Somatic Disease Among Alcohol Abusers in an Out-day Patients' Clinic. A Neglected Area | ||||
| Brief Summary | Alcohol abuse is associated with a variety of clinical diseases, but studies on prevalence of different somatic diseases among alcohol abusers are lacking. Studies on populations in an out-day patients' clinic are also lacking. The investigators aim to study somatic health standard in an out-day patients' clinic population of alcohol abusers, with regard to prevalence of different kinds of somatic diseases, and how the interaction of somatic and psychiatric treatment can influence on patients quality of life. Clinical examination including blood samples and echocardiographic examinations in all participants, other additional examinations (as x-ray, CT or MRI if indicated by clinical findings). |
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| Detailed Description | Retrospective methods will be used to study former somatic disease, cross-section design to study present somatic disease and prospective design to study quality of life, psychiatric and somatic health after combination of psychiatric and somatic examinations and treatment. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Conventional blood samples including i.e. glycosylated haemoglobin, serum ferritin, serum gamma-GT, B-type natriuretic peptide. |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Alcohol abusers referred to the out-day patients' clinic at Dep. of Psychiatry, Levanger Hospital, Norway |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Psychiatric and somatic examinations and ,if clinical indicated, treatment
Patients referred to the clinic will be given optimal treatment for revealed psychiatric and/or somatic disease including conversational therapy, and if indicated therapeutic interventions with respect to any kind of disease. |
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| Study Group/Cohort (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 150 | ||||
| Completion Date | May 2013 | ||||
| Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01081197 | ||||
| Other Study ID Numbers ICMJE | LE_ARP_Somatic_AlcoholAddicts | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Havard Dalen, Levanger Hospital | ||||
| Study Sponsor ICMJE | Levanger Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Levanger Hospital | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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