The Importance of Patient Education - A Randomised Controlled Trial

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00414154
• Other study ID #: 026
• Status: Completed
• Phase: Phase 0
• First received: December 20, 2006
• Last updated: February 23, 2011
• Start date: May 2002
• Est. completion date: May 2007

Study information

• Verified date: March 2007
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Behavior
• Level of Adherence
• Osteoporosis
• Quality of Life

Intervention

Behavioral:
• Group based multidisciplinary patient education programme

Locations

Country	Name	City	State
Denmark	Department of Endocrinology, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of compliance to pharmacological treatment
Secondary	Quality of life,
Secondary	Level of physical activity,
Secondary	Daily dietary calcium intake,
Secondary	registration of fall in and outdoor,
Secondary	Knowledge on Osteoporosis, BMD