Physical Health of Residents in Psychiatric Institutions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Aarhus University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00969384
First received: August 31, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Physical Health
Behavioral: Active awareness/Lifestyle counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Physical Health of Residents in Psychiatric Institutions

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • waist circumferences [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Enrollment: 350
Study Start Date: February 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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.

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.


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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Living in one of the 6 institutions in Region Nordjylland

Exclusion Criteria:

  • Not capable of speaking Danish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969384

Locations
Denmark
Enheden for psykiatrisk forskning
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aarhus University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Enheden for psykiatrisk forskning, Region Nordjylland
ClinicalTrials.gov Identifier: NCT00969384     History of Changes
Other Study ID Numbers: 3,3 270809
Study First Received: August 31, 2009
Last Updated: August 31, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:
Physical health
Mental illness
prevention
Waist circumference

ClinicalTrials.gov processed this record on April 20, 2014