The Importance of Patient Education - A Randomised Controlled Trial

NCT00414154 | Completed Early Phase 1

• 1 other identifier: 026
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

Group based patient education,; multidisciplinary,; physical activity,; adherence to treatment,; quality of life

Outcome Measures

Primary Outcomes (1)

• Level of compliance to pharmacological treatment

Secondary Outcomes (5)

• Quality of life,

• Level of physical activity,

• Daily dietary calcium intake,

• registration of fall in and outdoor,

• Knowledge on Osteoporosis, BMD

Interventions

Group based multidisciplinary patient education programme BEHAVIORAL

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and female age 45-80,
• Diagnosed with osteoporosis and started medical treatment

You may not qualify if:

• Severe illness,
• Cognitive dysfunction,
• Not able to speak or read Danish

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Department of Endocrinology, Odense University Hospital

Odense, Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Osteoporosis; Behavior; Motor Activity; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Health Behavior

Study Officials

• Kim Brixen, MD, Ph.D

  Institute of Clinical Research, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 21, 2006
• Study Start: May 1, 2002
• Study Completion: May 1, 2007
• Last Updated: February 24, 2011

Record last verified: 2007-03

Locations

DK (1)