Patient Education in Osteoporosis (RCT-PATOS)
Recruiting · NCT07367776 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Linkoeping
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- Possession of BankID (Swedish electronic identification system used for secure authentication) and ability to log in to the 1177.se "Support and Treatment platform"
Exclusion criteria
- 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
Where it is running
7 locations listed.
- Region Gävleborg - Gävle, Sweden
- Region Jönköpings län - Jönköping, Sweden
- Region Kalmar - Kalmar, Sweden
- Region Sörmland - Katrineholm, Sweden
- Region Halland - Kungsbacka, Sweden
- Region Östergötland - Linköping, Sweden
- Region Örebro - Örebro, Sweden