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Physical Health of Residents in Psychiatric Institutions

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ClinicalTrials.gov Identifier: NCT00969384
Recruitment Status : Unknown
Verified August 2009 by Aarhus University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2009
Last Update Posted : September 1, 2009
Sponsor:
Information provided by:
Aarhus University Hospital

Tracking Information
First Submitted Date  ICMJE August 31, 2009
First Posted Date  ICMJE September 1, 2009
Last Update Posted Date September 1, 2009
Study Start Date  ICMJE February 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2009)
waist circumferences [ Time Frame: 9 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Health of Residents in Psychiatric Institutions
Official Title  ICMJE Physical Health of Residents in Psychiatric Institutions
Brief Summary

Aim of the study: To investigate if the intervention described in this protocol has an effect on patients' and staff's physical health.

Null hypothesis: There is no difference in waist circumference, body weight, quality of life and the rate of polypharmacy between the intervention and control groups after six months.

Detailed Description

Background:

The prevalence of physical health problems among patients suffering from psychiatric illnesses is above that seen in the average population (1). Cardiovascular diseases (2) and metabolic disorders (3;4) are common in persons diagnosed with schizophrenia (5;6). A fact that has been known for many years (7), and there has been no decrease in the prevalence of physical illness in connection with the decentralization of the psychiatric treatment which has taken place in the Western world during the last 30-40 years (8).

Meta-analyses describe increased physical morbidity among patients with psychiatric diseases and increased mortality on account of somatic diseases (7). One of the reasons for the increased mortality could be the use of second generation antipsychotics that in some cases cause weight gain and metabolic syndrome which is associated with a two to threefold increase in cardiovascular mortality and a twofold increase in all-cause mortality (3;9). These effects would be expected to contribute to even higher mortality in the following years (10).

The use of more than one antipsychotic drug, polypharmacy, might also play a role (11;12). Psychiatric societies, national and international health authorities advise against the use of polypharmacy (13).

The quality of the general health care in patients with severe mental illness and the consensus about the prevention of somatic illness in this group of vulnerable patients need to be improved and there is evidence signifying the importance of the situation (14;15).

We need more knowledge about how to integrate the prevention and care of somatic illness to this group of patients with severe psychiatric illness.

This study investigates ways to improve the physical health of people with a psychiatric diagnosis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Physical Health
Intervention  ICMJE Behavioral: Active awareness/Lifestyle counseling

Intervention (active awareness):

In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided.

Study Arms  ICMJE
  • Experimental: waist circumferences

    Intervention (active awareness):

    In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided.

    Intervention: Behavioral: Active awareness/Lifestyle counseling
  • Experimental: Lifestyle counseling

    Intervention (active awareness):

    In the intervention institutions, a detailed feedback of all index measures will be distributed to the patients and the staff. The project leader and a medical specialist in psychiatry will advise on medical aspects and health promotion. In connection with this feedback, guidance on psycho-pharmacological treatment will be provided.

    Intervention: Behavioral: Active awareness/Lifestyle counseling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 31, 2009)
350
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Living in one of the 6 institutions in Region Nordjylland

Exclusion Criteria:

  • Not capable of speaking Danish
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00969384
Other Study ID Numbers  ICMJE 3,3 270809
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Enheden for psykiatrisk forskning, Region Nordjylland
Study Sponsor  ICMJE Aarhus University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Mr Hjorth, MPH Unit for Psychiatric research North Jutland
Study Director: Povl Mr Munk Joergensen, Professor Unit for psychiatric research North Jutland
PRS Account Aarhus University Hospital
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP