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The Importance of Patient Education - A Randomised Controlled Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414154
First Posted: December 21, 2006
Last Update Posted: February 24, 2011
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.
Information provided by:
Odense University Hospital
  Purpose

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 Intervention Phase
Osteoporosis Quality of Life Level of Adherence Behavior Behavioral: Group based multidisciplinary patient education programme Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Level of compliance to pharmacological treatment

Secondary Outcome Measures:
  • Quality of life,
  • Level of physical activity,
  • Daily dietary calcium intake,
  • registration of fall in and outdoor,
  • Knowledge on Osteoporosis, BMD

Estimated Enrollment: 300
Study Start Date: May 2002
Estimated Study Completion Date: May 2007
  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00414154


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

ClinicalTrials.gov Identifier: NCT00414154     History of Changes
Other Study ID Numbers: 026
First Submitted: December 20, 2006
First Posted: December 21, 2006
Last Update Posted: February 24, 2011
Last Verified: March 2007

Keywords provided by Odense University Hospital:
Group based patient education,
multidisciplinary,
physical activity,
adherence to treatment,
quality of life

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases