The Importance of Patient Education - A Randomised Controlled Trial
|ClinicalTrials.gov Identifier: NCT00414154|
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : February 24, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoporosis Quality of Life Level of Adherence Behavior||Behavioral: Group based multidisciplinary patient education programme||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect of a Group Based Multidisciplinary Patient Education Programme for Patients With Osteoporosis - a Controlled Randomised Trial|
|Study Start Date :||May 2002|
|Estimated Study Completion Date :||May 2007|
- Level of compliance to pharmacological treatment
- Quality of life,
- Level of physical activity,
- Daily dietary calcium intake,
- registration of fall in and outdoor,
- Knowledge on Osteoporosis, BMD
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00414154
|Department of Endocrinology, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Kim Brixen, MD, Ph.D||Institute of Clinical Research, University of Southern Denmark|