Patient Education in Osteoporosis (RCT-PATOS)

Sponsor
University Hospital, Linkoeping
Study ID
NCT07367776
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Digital patient education — BEHAVIORAL
    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.
  • Face-to-face patient education — BEHAVIORAL
    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.
  • General information on osteoporosis (open website) — BEHAVIORAL
    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/ ).

Study Details

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.

Key Dates

Start date
Jan 27, 2026
Status verified
Mar 2026
Primary completion
Oct 20, 2028
Completion
Oct 20, 2028

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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

Primary Outcome Measure

Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 12 months) [ Time Frame: Baseline to follow up at 12 months. ]

Central Contacts

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