About this trial
The objective of this randomized clinical trial is to assess both the effectiveness and underlying mechanisms of patient education for individuals aged 50 years and older with osteoporosis.
Primary research question: What differences in outcomes can be observed among three different educational interventions with respect to osteoporosis-specific self-care, health related quality of life, fracture risk, illness perception, physical activity, physical function, fear of falling, and pain in patients diagnosed with osteoporosis?
The trial will include three study arms: 1) Control group: Participants receive standard osteoporosis information provided by healthcare services. 2) Face-to-face education: Three 2-hours sessions led by a physiotherapist (two sessions) and physician or nurse (one session) within a 2 months period. 3) Digital education: Internet-based program consisting of nine modules accessible to participants over a one-year period.
Participants will complete questionnaires and undergo physical assessments at baseline, and at 3 and 12 months follow up. Additionally, a subset of participants will undergo objective assessment of physical activity pattern and sedentary behaviours with an accelerometer at baseline and after 3 and 12 months.
Eligibility criteria
Qualifiers
Women and men
Age > 50 years
Diagnosed with osteoporosis or osteopenia (either ICD-coded [M80x, M81x, or M859] or current/previous pharmacological treatment for osteoporosis)
Basic computer literacy
Disqualifiers
Inability to understand written and spoken Swedish
Cognitive impairment preventing comprehension of the study protocol and provision of informed consent
Participation in structured patient education on osteoporosis within the past year
Trial design
Treatments tested in this trial
- Digital patient education
- Face-to-face patient education
- General information on osteoporosis (open website)
Treatment groups
Sponsors and collaborators
University Hospital, Linkoeping
Lead sponsor
Örebro County Council
Collaborator
Region Kalmar County
Collaborator
County Council of Halland, Sweden
Collaborator
Sormland County Council, Sweden
Collaborator
County Council of Gavleborg
Collaborator
Region Jönköping County
Collaborator