Clinical trial NCT00414154: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Osteoporosis
Quality of Life
Level of Adherence
Behavior
Keywords: Group based patient education,
multidisciplinary,
physical activity,
adherence to treatment,
quality of life
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2006-12-21
Enrollment: 300
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Level of compliance to pharmacological treatment
Secondary outcomes:
measure: Quality of life,
measure: Level of physical activity,
measure: Daily dietary calcium intake,
measure: registration of fall in and outdoor,
measure: Knowledge on Osteoporosis, BMD
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
Study officials:
affiliation: Institute of Clinical Research, University of Southern Denmark
name: Kim Brixen, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: