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Somatic Disease Among Alcohol Abusers in an Out-day Patients' Clinic

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01081197
First Posted: March 5, 2010
Last Update Posted: May 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Havard Dalen, Levanger Hospital
  Purpose

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).


Condition Intervention
HEART DISEASE Liver Failure DEPRESSIVE DISORDER Alcoholic Neuropathy Other: Psychiatric and somatic examinations and ,if clinical indicated, treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Somatic Disease Among Alcohol Abusers in an Out-day Patients' Clinic. A Neglected Area

Resource links provided by NLM:


Further study details as provided by Havard Dalen, Levanger Hospital:

Primary Outcome Measures:
  • Prevalence of different kinds of somatic disease [ Time Frame: 3 months after inclusion ]
    Prevalence of somatic disease at study attendance of any kind, specified for heart disease, gall- and liver disease, neuropathic disease.


Secondary Outcome Measures:
  • Prevalence of former somatic disease [ Time Frame: 3 months after inclusion ]
    Prevalence of former somatic disease investigated by anamnestic examination, search in patient journals and communication with the patients community health service.

  • Outcome of psychiatric and somatic treatment of alcohol abusers [ Time Frame: 1 year after stopped inclusion ]
    Quality of life and score of somatic and psychiatric health 1 year after inclusion


Biospecimen Retention:   Samples Without DNA
Conventional blood samples including i.e. glycosylated haemoglobin, serum ferritin, serum gamma-GT, B-type natriuretic peptide.

Enrollment: 150
Study Start Date: March 2010
Study Completion Date: May 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Out-day patients' clinic
Alcohol abusers referred to out-day patients' clinic which consent to participate in the study
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.
Control
Control group for the cardiac arm of the study will be matched controls from the Nord-Trøndelag Health Study (HUNT)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Alcohol abusers referred to the out-day patients' clinic at Dep. of Psychiatry, Levanger Hospital, Norway
Criteria

Inclusion Criteria:

  • Alcohol abusers reffered to the out-day patients' clinic at Dep. of Psychiatry, Levanger Hospital, Norway

Exclusion Criteria:

  • Not consenting to participate
  • Not able to consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01081197


Locations
Norway
Levanger Hospital, Dep. of Psychiatry
Levanger, Norway, N-7600
Sponsors and Collaborators
Levanger Hospital
Investigators
Principal Investigator: Erling Dalen, MD Levanger Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Havard Dalen, MD, PhD, Levanger Hospital
ClinicalTrials.gov Identifier: NCT01081197     History of Changes
Other Study ID Numbers: LE_ARP_Somatic_AlcoholAddicts
First Submitted: March 4, 2010
First Posted: March 5, 2010
Last Update Posted: May 3, 2013
Last Verified: May 2013

Keywords provided by Havard Dalen, Levanger Hospital:
heart failure
liver
depression
neuropathy

Additional relevant MeSH terms:
Heart Diseases
Depressive Disorder
Depression
Liver Failure
Alcoholic Neuropathy
Cardiovascular Diseases
Mood Disorders
Mental Disorders
Behavioral Symptoms
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Polyneuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Alcohol-Induced Disorders, Nervous System
Neurotoxicity Syndromes
Poisoning
Chemically-Induced Disorders
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders