Patient Education in Osteoporosis (RCT-PATOS)
RCT-PATOS
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)
1 other identifier
interventional
600
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2026
Typical duration for not_applicable
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2026
CompletedFirst Posted
Study publicly available on registry
January 26, 2026
CompletedStudy Start
First participant enrolled
January 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 20, 2028
March 17, 2026
March 1, 2026
2.7 years
January 7, 2026
March 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 12 months)
The OsCare questionnaire is a self-administered assessment designed to evaluate patients' knowledge, motivation, and behavior related to osteoporosis management. It consists of items rated on an ordinal scale, where higher values indicate more favorable responses. The instrument yields both an overall score reflecting the general level of osteoporosis-related self-care, and subscale scores corresponding to the individual domains (knowledge, motivation, and behavior).
Baseline to follow up at 12 months.
Secondary Outcomes (20)
Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 3 months)
Baseline to follow-up at 3 months.
Health-related quality of life (HRQoL) - RAND-36
Baseline to follow-up at 3 months and 12 months.
Health-related quality of life (HRQoL) - EQ-5D-5L
Baseline to follow-up at 3 months and 12 months.
Patient enablement instrument (PEI)
3 months and 12 months
Fear of falling
Baseline to follow-up at 3 months and 12 months.
- +15 more secondary outcomes
Other Outcomes (2)
Accelerometer-based assessment of physical activity and sedentary behaviours
Baseline to follow-up at 3 months and 12 months.
Adverse event
Baseline to follow-up at 3 months and 12 months
Study Arms (3)
Usual care (Control)
ACTIVE COMPARATORGeneral information on osteoporosis (open website)
Face-to-face patient education
ACTIVE COMPARATORStructured group-based theoretical education ('osteoporosis school')
Digital patient education
ACTIVE COMPARATORInternet-based patient education program
Interventions
Three theoretical sessions, each lasting two hours, will be conducted over a period of 3-5 weeks. The sessions adhere to a standardized curriculum addressing key aspects of osteoporosis management. Two sessions will be led by physiotherapists, and one session by either a physician or a nurse. Each group will include a maximum of 15 participants. Intervention adherence will be monitored. For the group-based intervention, attendance at scheduled sessions will be recorded.
Participants receive general osteoporosis information provided by healthcare services (open website with general information on osteoporosis: https://www.1177.se/sjukdomar--besvar/skelett-leder-och-muskler/benskorhet---osteoporos/ ).
An internet-based program comprising nine modules will be available to participants for a duration of one year. The program addresses essential components of patient education in osteoporosis and includes a variety of learning formats such as text, images, videos, reflection exercises, knowledge-check questions, and checklists. The estimated total time required to complete the program is approximately 5.5 hours. Intervention adherence will be monitored. For the digital intervention, adherence will be assessed by number of modules accessed.
Eligibility Criteria
You may qualify if:
- 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"
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- County Council of Halland, Swedencollaborator
- Sormland County Council, Swedencollaborator
- County Council of Gavleborgcollaborator
- Region Jönköping Countycollaborator
- Örebro County Councilcollaborator
- Kalmar County Councilcollaborator
- University Hospital, Linkoepinglead
Study Sites (7)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anna Spångeus, Ass Prof MD
Region Östergötland
- PRINCIPAL INVESTIGATOR
Johanna Wibault, PhD
Region Östergötland
- PRINCIPAL INVESTIGATOR
Gunnel Peterson, Assoc Prof
Sormland County Council, Sweden
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Associated Professor, Senior Consultant
Study Record Dates
First Submitted
January 7, 2026
First Posted
January 26, 2026
Study Start
January 27, 2026
Primary Completion (Estimated)
October 20, 2028
Study Completion (Estimated)
October 20, 2028
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share