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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)

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Sweden
Region Gävleborg
NOT_YET_RECRUITING
Gävle
Region Jönköpings län
NOT_YET_RECRUITING
Jönköping
Region Kalmar
RECRUITING
Kalmar
Region Sörmland
RECRUITING
Katrineholm
Region Halland
NOT_YET_RECRUITING
Kungsbacka
Region Östergötland
RECRUITING
Linköping
Region Örebro
RECRUITING
Örebro
Contact Information
Primary
Anna Spångeus, Ass Prof MD
anna.spangeus@liu.se
+46-10-1030000
Backup
Johanna Wibault, PhD
johanna.wibault@regionostergotland.se
+46-10-1030000
Time Frame
Start Date: 2026-01-27
Estimated Completion Date: 2028-10-20
Participants
Target number of participants: 600
Treatments
Active_comparator: Usual care (Control)
General information on osteoporosis (open website)
Active_comparator: Face-to-face patient education
Structured group-based theoretical education ('osteoporosis school')
Active_comparator: Digital patient education
Internet-based patient education program
Related Therapeutic Areas
Sponsors
Collaborators: County Council of Halland, Sweden, Sormland County Council, Sweden, Region Jönköping County, County Council of Gavleborg, Örebro County Council, Kalmar County Council
Leads: University Hospital, Linkoeping

This content was sourced from clinicaltrials.gov