Physical Health of Residents in Psychiatric Institutions

NCT ID: NCT00969384

Last Updated: 2009-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28

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.

Conditions

Physical Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Active awareness/Lifestyle counseling

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Active awareness/Lifestyle counseling

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Living in one of the 6 institutions in Region Nordjylland

Exclusion Criteria

• Not capable of speaking Danish

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Region Nordjylland

Principal Investigators

Peter Mr Hjorth, MPH

Role: PRINCIPAL_INVESTIGATOR

Unit for Psychiatric research North Jutland

Povl Mr Munk Joergensen, Professor

Role: STUDY_DIRECTOR

Unit for psychiatric research North Jutland

Locations

Enheden for psykiatrisk forskning

Aalborg, , Denmark

Countries

Denmark

Other Identifiers

3,3 270809

Identifier Type: -

Identifier Source: org_study_id