- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00969384
Physical Health of Residents in Psychiatric Institutions
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Aalborg, Danmark, 9000
- Enheden for psykiatrisk forskning
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Living in one of the 6 institutions in Region Nordjylland
Exclusion Criteria:
- Not capable of speaking Danish
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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. |
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. |
Eksperimentell: 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 (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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
waist circumferences
Tidsramme: 9 months
|
9 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Peter Mr Hjorth, MPH, Unit for psychiatric research North Jutland
- Studieleder: Povl Mr Munk Joergensen, Professor, Unit for psychiatric research North Jutland
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 3,3 270809
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