Face-to-face versus online versus standard education for people with osteoporosis
Effects and Mechanisms of Patient Education in Osteoporosis: A Randomized Controlled Trial Comparing Digital Education, Face-to-Face Education, and General Patient Information (RCT-PATOS)
This project will test whether in-person classes or an online education program help people aged 50 and older with osteoporosis manage their condition better than usual information.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University Hospital, Linkoeping Academic / other |
| Locations | 7 sites (Gävle and 6 other locations) |
| Trial ID | NCT07367776 on ClinicalTrials.gov |
What this trial studies
This randomized trial enrolls men and women aged over 50 with osteoporosis or osteopenia and assigns them to one of three arms: standard information, three two-hour face-to-face education sessions delivered over two months, or an internet-based program of nine modules available for one year. Outcomes measured by questionnaires and clinical data include osteoporosis-specific self-care, health-related quality of life, fracture risk, illness perception, physical activity, physical function, fear of falling, and pain. The face-to-face sessions are led by physiotherapists and a physician or nurse, while the digital arm requires basic computer literacy and Swedish BankID access to the 1177.se platform. Follow-up assessments will compare effectiveness of delivery formats and explore how each approach influences behavior and health outcomes.
Who should consider this trial
Good fit: Men and women aged over 50 with a clinical diagnosis of osteoporosis or osteopenia who understand Swedish, have basic computer skills, and can log in with BankID are the ideal candidates.
Not a fit: People who do not understand written or spoken Swedish, have cognitive impairment preventing informed consent, are unable to use the digital platform, or who received structured osteoporosis education in the past year may not benefit or be eligible.
Why it matters
Potential benefit: If successful, the trial could identify an education format that improves self-care, quality of life, and potentially lowers fracture risk or its consequences for older adults with osteoporosis.
How similar studies have performed: Previous patient education programs have improved knowledge and some self-care behaviors but have shown mixed effects on quality of life and fracture outcomes, so directly comparing delivery methods is partly novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gävle and 6 other locations
- Region Gävleborg — Gävle, Sweden (Not_yet_recruiting)
- Region Jönköpings län — Jönköping, Sweden (Not_yet_recruiting)
- Region Kalmar — Kalmar, Sweden (Recruiting)
- Region Sörmland — Katrineholm, Sweden (Recruiting)
- Region Halland — Kungsbacka, Sweden (Not_yet_recruiting)
- Region Östergötland — Linköping, Sweden (Recruiting)
- Region Örebro — Örebro, Sweden (Recruiting)
Study contacts
- Principal investigator: Johanna Wibault, PhD — Region Östergötland
- Study coordinator: Anna Spångeus, Ass Prof MD
- Email: anna.spangeus@liu.se
- Phone: +46-10-1030000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.