Overview

This trial is active, not recruiting.

Condition physical health
Treatment active awareness/lifestyle counseling
Sponsor Aarhus University Hospital
Start date February 2009
End date August 2009
Trial size 350 participants
Trial identifier NCT00969384, 3,3 270809

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
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)
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.
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 Outcomes

Measure
waist circumferences
time frame: 9 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Living in one of the 6 institutions in Region Nordjylland Exclusion Criteria: - Not capable of speaking Danish

Additional Information

Official title Physical Health of Residents in Psychiatric Institutions
Principal investigator Peter Mr Hjorth, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2009.
Information provided to ClinicalTrials.gov by Aarhus University Hospital.