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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Havard Dalen, Levanger Hospital
ClinicalTrials.gov Identifier:
NCT01081197
First received: March 4, 2010
Last updated: May 2, 2013
Last verified: May 2013
  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 Levanger Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Prevalence of former somatic disease [ Time Frame: 3 months after inclusion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Responsible Party: Havard Dalen, MD, PhD, Levanger Hospital
ClinicalTrials.gov Identifier: NCT01081197     History of Changes
Other Study ID Numbers: LE_ARP_Somatic_AlcoholAddicts
Study First Received: March 4, 2010
Last Updated: May 2, 2013
Health Authority: Norway: Ethics Committee

Keywords provided by Levanger Hospital:
heart failure
liver
depression
neuropathy

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

ClinicalTrials.gov processed this record on July 26, 2014