The Importance of Patient Education - A Randomised Controlled Trial

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of a Group Based Multidisciplinary Patient Education Programme for Patients With Osteoporosis - a Controlled Randomised Trial

Conditions
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Osteoporosis, Quality of Life, Level of Adherence, Behavior

Intervention / Treatment
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* Behavioral: Group based multidisciplinary patient education programme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Group based multidisciplinary patient education programme|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of compliance to pharmacological treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life, |  |  | 
| Level of physical activity, |  |  | 
| Daily dietary calcium intake, |  |  | 
| registration of fall in and outdoor, |  |  | 
| Knowledge on Osteoporosis, BMD |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group based patient education,, multidisciplinary,, physical activity,, adherence to treatment,, quality of life