Clinical trial NCT00969384: Physical Health of Residents in Psychiatric Institutions
Official title: Physical Health of Residents in Psychiatric Institutions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Health
Keywords: Physical health
Mental illness
prevention
Waist circumference
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2009-09-01
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Living in one of the 6 institutions in Region Nordjylland

Exclusion Criteria:

* Not capable of speaking Danish

Primary outcomes:
measure: waist circumferences
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Enheden for psykiatrisk forskning
Study officials:
affiliation: Unit for Psychiatric research North Jutland
name: Peter Mr Hjorth, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Unit for psychiatric research North Jutland
name: Povl Mr Munk Joergensen, Professor
role: STUDY_DIRECTOR
References: