Patient Education in Osteoporosis (RCT-PATOS)

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.

Conditions

• Osteoporosis

Interventions

BEHAVIORAL

Digital patient education

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.

BEHAVIORAL

Face-to-face patient education

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.

BEHAVIORAL

General information on osteoporosis (open website)

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/ ).

Sponsors & Collaborators

• Örebro County Council

  collaborator OTHER_GOV

• Kalmar County Council

  collaborator UNKNOWN

• County Council of Halland, Sweden

  collaborator OTHER_GOV

• Sormland County Council, Sweden

  collaborator OTHER

• County Council of Gavleborg

  collaborator OTHER

• Region Jönköping County

  collaborator OTHER_GOV

• University Hospital, Linkoeping

  lead OTHER

Principal Investigators

• Anna Spångeus, Ass Prof MD · Region Östergötland

• Johanna Wibault, PhD · Region Östergötland

• Gunnel Peterson, Assoc Prof · Sormland County Council, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-27

Primary Completion

2028-10-20

Completion

2028-10-20

Countries

• Sweden

Study Locations