Physical Health of Residents in Psychiatric Institutions

Not Applicable

• Conditions: Physical Health
• Interventions: Behavioral: Active awareness/Lifestyle counseling

• Registration Number: NCT00969384
• Lead Sponsor: Aarhus University Hospital

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 Timeline

• Study Start: 2009-02
• Status Verified: 2009-08
• Primary Completion: 2009-08
• Study First Submitted: 2009-08-31
• Study First Submitted QC: 2009-08-31
• Last Update Submitted: 2009-08-31
• Study First Posted: 2009-09-01
• Last Update Posted: 2009-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

• Living in one of the 6 institutions in Region Nordjylland

Exclusion Criteria

• Not capable of speaking Danish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
waist circumferences	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.
Lifestyle counseling	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.

Primary Outcome Measures

Name	Time	Method
waist circumferences	9 months

Trial Locations

Locations (1)

Enheden for psykiatrisk forskning; 🇩🇰 Aalborg, Denmark