Patient Education in Osteoporosis (RCT-PATOS)

ConditionOsteoporosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity Hospital, Linkoeping

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

600 Participants
are divided into 3 treatment groups

Sponsors and collaborators

University Hospital, Linkoeping

Lead sponsor

Örebro County Council

Collaborator

Region Kalmar County

Collaborator

County Council of Halland, Sweden

Collaborator

Sormland County Council, Sweden

Collaborator

County Council of Gavleborg

Collaborator

Region Jönköping County

Collaborator