The Importance of Patient Education - A Randomised Controlled Trial

NCT ID: NCT00414154

Last Updated: 2011-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2007-05-31

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.

Conditions

Osteoporosis; Quality of Life; Level of Adherence; Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Group based multidisciplinary patient education programme

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Kim Brixen, MD, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Institute of Clinical Research, University of Southern Denmark

Locations

Department of Endocrinology, Odense University Hospital

Odense, Odense, Denmark

Countries

Denmark

Other Identifiers

026

Identifier Type: -

Identifier Source: org_study_id