HEART DISEASENCT01081197
Somatic Disease Among Alcohol Abusers in an Out-day Patients' Clinic
An observational study of HEART DISEASE and Liver Failure, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HEART DISEASE, Liver Failure, DEPRESSIVE DISORDER
- What is being tested?
- Psychiatric and somatic examinations and ,if clinical indicated, treatment
- How many people
- 150 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2010to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Alcohol abusers referred to the out-day patients' clinic at Dep. of Psychiatry, Levanger Hospital, Norway
Who may be able to join
- Alcohol abusers reffered to the out-day patients' clinic at Dep. of Psychiatry, Levanger Hospital, Norway
Who cannot join
- Not consenting to participate
- Not able to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Somatic Disease Among Alcohol Abusers in an Out-day Patients' Clinic. A Neglected Area
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).
Read the 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.
- Being tested
- Psychiatric and somatic examinations and ,if clinical indicated, treatment
- Keywords
- heart failure, liver, depression, neuropathy
- Medical subject headings
- Heart Diseases, Liver Failure, Depressive Disorder, Alcoholic Neuropathy, Heart Failure, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychiatric and somatic examinations and ,if clinical indicated, treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Out-day patients' clinic | Alcohol abusers referred to out-day patients' clinic which consent to participate in the study Receives: Other: Psychiatric and somatic examinations and ,if clinical indicated, treatment | |
| Control | Control group for the cardiac arm of the study will be matched controls from the Nord-Trøndelag Health Study (HUNT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of different kinds of somatic disease
Prevalence of somatic disease at study attendance of any kind, specified for heart disease, gall- and liver disease, neuropathic disease.
Measured: 3 months after inclusion
Secondary outcomes (2)
Prevalence of former somatic disease
Prevalence of former somatic disease investigated by anamnestic examination, search in patient journals and communication with the patients community health service.
Measured: 3 months after inclusion
Outcome of psychiatric and somatic treatment of alcohol abusers
Quality of life and score of somatic and psychiatric health 1 year after inclusion
Measured: 1 year after stopped inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HEART DISEASEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erling Dalen, MD, Principal investigator, Helse Nord-Trøndelag HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01081197
- Sponsor's protocol ID
- LE_ARP_Somatic_AlcoholAddicts
- Status last verified
- Nov 2021
- First submitted
- 4 Mar 2010
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Moss M, Parsons PE, Steinberg KP, Hudson LD, Guidot DM, Burnham EL, Eaton S, Cotsonis GA. Chronic alcohol abuse is associated with an increased incidence of acute respiratory distress syndrome and severity of multiple organ dysfunction in patients with septic shock. Crit Care Med. 2003 Mar;31(3):869-77. doi: 10.1097/01.CCM.0000055389.64497.11.
PubMed 12626999Awtry EH, Philippides GJ. Alcoholic and cocaine-associated cardiomyopathies. Prog Cardiovasc Dis. 2010 Jan-Feb;52(4):289-99. doi: 10.1016/j.pcad.2009.11.004.
PubMed 20109599Moss M, Burnham EL. Alcohol abuse in the critically ill patient. Lancet. 2006 Dec 23;368(9554):2231-42. doi: 10.1016/S0140-6736(06)69490-7.
PubMed 17189035Dalen E, Holmen J, Nordahl HM. Somatic health of patients at an outpatient clinic for substance abuse. Tidsskr Nor Laegeforen. 2015 Jan 27;135(2):127-31. doi: 10.4045/tidsskr.13.0801. eCollection 2015 Jan 27. English, Norwegian.
PubMed 25625990
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatic Disease Among Alcohol Abusers in an Out-day Patients' Clinic. A Neglected Area
- ClinicalTrials.gov ID
- NCT01081197
- Acronym / sponsor ID
- LE_ARP_Somatic_AlcoholAddicts
- Keywords
- heart failure, liver, depression, neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 5 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Out-day patients' clinic | – | Other: Psychiatric and somatic examinations and ,if clinical indicated, treatmentAlcohol abusers referred to out-day patients' clinic which consent to participate in the study |
| Control | – | –Control group for the cardiac arm of the study will be matched controls from the Nord-Trøndelag Health Study (HUNT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Alcohol abusers referred to the out-day patients' clinic at Dep. of Psychiatry, Levanger Hospital, Norway
Key inclusion criteria (1 listed)
- Alcohol abusers reffered to the out-day patients' clinic at Dep. of Psychiatry, Levanger Hospital, Norway
Key exclusion criteria (2 listed)
- Not consenting to participate
- Not able to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychiatric and somatic examinations and ,if clinical indicated, treatmentPatients 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. | Other | Out-day patients' clinic |
Primary outcome
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.
2 secondary outcomes
Prevalence of former somatic disease
Time frame: 3 months after inclusion
Outcome of psychiatric and somatic treatment of alcohol abusers
Time frame: 1 year after stopped inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Background: PubMed 12626999Moss M, Parsons PE, Steinberg KP, Hudson LD, Guidot DM, Burnham EL, Eaton S, Cotsonis GA. Chronic alcohol abuse is associated with an increased incidence of acute respiratory distress syndrome and severity of multiple organ dysfunction in patients with septic shock. Crit Care Med. 2003 Mar;31(3):869-77. doi: 10.1097/01.CCM.0000055389.64497.11.
- Background: PubMed 20109599Awtry EH, Philippides GJ. Alcoholic and cocaine-associated cardiomyopathies. Prog Cardiovasc Dis. 2010 Jan-Feb;52(4):289-99. doi: 10.1016/j.pcad.2009.11.004.
- Background: PubMed 17189035Moss M, Burnham EL. Alcohol abuse in the critically ill patient. Lancet. 2006 Dec 23;368(9554):2231-42. doi: 10.1016/S0140-6736(06)69490-7.
- Derived from this study: PubMed 25625990Dalen E, Holmen J, Nordahl HM. Somatic health of patients at an outpatient clinic for substance abuse. Tidsskr Nor Laegeforen. 2015 Jan 27;135(2):127-31. doi: 10.4045/tidsskr.13.0801. eCollection 2015 Jan 27. English, Norwegian.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erling Dalen, MD principal investigator
Helse Nord-Trøndelag HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HEART DISEASE and Liver Failure, run by Helse Nord-Trøndelag HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of different kinds of somatic disease (time frame: 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01081197, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.