The Importance of Patient Education - A Randomised Controlled Trial
Primary Purpose
Osteoporosis, Quality of Life, Level of Adherence
Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Group based multidisciplinary patient education programme
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring Group based patient education,, multidisciplinary,, physical activity,, adherence to treatment,, quality of life
Eligibility 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
Sites / Locations
- Department of Endocrinology, Odense University Hospital
Outcomes
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
Full Information
NCT ID
NCT00414154
First Posted
December 20, 2006
Last Updated
February 23, 2011
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00414154
Brief Title
The Importance of Patient Education - A Randomised Controlled Trial
Official Title
The Effect of a Group Based Multidisciplinary Patient Education Programme for Patients With Osteoporosis - a Controlled Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Odense University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Quality of Life, Level of Adherence, Behavior
Keywords
Group based patient education,, multidisciplinary,, physical activity,, adherence to treatment,, quality of life
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Group based multidisciplinary patient education programme
Primary Outcome Measure Information:
Title
Level of compliance to pharmacological treatment
Secondary Outcome Measure Information:
Title
Quality of life,
Title
Level of physical activity,
Title
Daily dietary calcium intake,
Title
registration of fall in and outdoor,
Title
Knowledge on Osteoporosis, BMD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Brixen, MD, Ph.D
Organizational Affiliation
Institute of Clinical Research, University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Endocrinology, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
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The Importance of Patient Education - A Randomised Controlled Trial
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