- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00414154
The Importance of Patient Education - A Randomised Controlled Trial
The Effect of a Group Based Multidisciplinary Patient Education Programme for Patients With Osteoporosis - a Controlled Randomised Trial
Modification of individual life style factors and fall prevention programmes may have significant positive effects on fracture incidence. Also, a large number of studies have demonstrated that pharmacological therapy of osteoporosis is effective; however non-adherence to such therapy is a well recognized problem. Few studies, however, have examined the effect of particular patient education programmes on knowledge and adherence to therapy.
We hypothesised that a group-based, multi-disciplinary, education programme increases the total quality of treatment for patients with osteoporosis, Patients' knowledge on osteoporosis and adherence with pharmacological therapy ect.
A total of 300 patients, recently diagnosed with osteoporosis and started on specific treatment, were randomised to either the "school" or "control" group. In the school-group, patients attended four classes with 8-12 participants during four weeks (a total of 12 hours). Teaching was performed by nurses, physiotherapists, dieticians, and doctors and was based on dialogs and situated learning. The classes covered "facts on osteoporosis", "fractures and pain", "diet", "preventive measures", "balance and exercise", and "medical treatment". Teaching was designed to increase empowerment. The control group were offered the department's standard treatment including follow-up visits.
All 300 patients received questionnaires regarding "Knowledge about Osteoporosis", "Level of Adherence", "Quality of life", "Dietary calcium intake", "Level of physical activity", "Falls events" registered every month by postcard, at inclusion and after 3, 12, and 24 month. BMD was examined by DXA-scan at inclusion and after 12 and 24 month. The last patient will answer the questionnaires first of May 2007.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiesteder
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Odense, Danmark, 5000
- Department of Endocrinology, Odense University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Men and female age 45-80,
- Diagnosed with osteoporosis and started medical treatment
Exclusion Criteria:
- Severe illness,
- Cognitive dysfunction,
- Not able to speak or read Danish
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
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Level of compliance to pharmacological treatment
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Sekundære resultatmål
Resultatmål |
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Quality of life,
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Level of physical activity,
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Daily dietary calcium intake,
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registration of fall in and outdoor,
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Knowledge on Osteoporosis, BMD
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kim Brixen, MD, Ph.D, Institute of Clinical Research, University of Southern Denmark
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 026
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