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The Importance of Patient Education - A Randomised Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00414154
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : February 24, 2011
Information provided by:
Odense University Hospital

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

Primary Outcome Measures :
  1. Level of compliance to pharmacological treatment

Secondary Outcome Measures :
  1. Quality of life,
  2. Level of physical activity,
  3. Daily dietary calcium intake,
  4. registration of fall in and outdoor,
  5. Knowledge on Osteoporosis, BMD

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00414154

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Department of Endocrinology, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
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Principal Investigator: Kim Brixen, MD, Ph.D Institute of Clinical Research, University of Southern Denmark

Layout table for additonal information Identifier: NCT00414154    
Other Study ID Numbers: 026
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: March 2007
Keywords provided by Odense University Hospital:
Group based patient education,
physical activity,
adherence to treatment,
quality of life
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases