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NCT Number: NCT07367776

Patient Education in Osteoporosis (RCT-PATOS)

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Gävleborg, Gävle, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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"

Exclusion criteria

  • 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

Treatment and study plan

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/ ).

Primary outcomes

  1. Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 12 months)

    Time frame: 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).

Secondary outcomes

  1. Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 3 months)

    Time frame: Baseline to follow-up at 3 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).

  2. Health-related quality of life (HRQoL) - RAND-36

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Assessed with RAND 36-Item Health Survey. The RAND-36 compromises 36 items covering 8 health-related domains.

  3. Health-related quality of life (HRQoL) - EQ-5D-5L

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Assessed with the EuroQol 5 Dimensions (EQ5D-5L) and Visual Analogue Scale (VAS 0-100) where respondents rate their overall health.

  4. Patient enablement instrument (PEI)

    Time frame: 3 months and 12 months

    Measured with the Patient Enablement Instrument (PEI).

  5. Fear of falling

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Assessed with Falls Efficacy Scale-International (FES-I). The FES-I is a 16-item questionnaire.

  6. Illness perception

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Assessed with the Brief-Illness Perception Questionnaire BIPQ which is an 8-item questionnaire.

  7. Beliefs about the necessity of prescribed medication

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Assessed using Beliefs about Medicines Questionnaire (BMQ).

  8. Physical activity (self-reported)

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Measured with questions from the Swedish Questionnaire about Lifestyle Habits.

  9. Fall incidence (self-reported)

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Self-reported numbers of fall during the last 3 and 12 months

  10. Perceived balance (self-reported)

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Self-rated perceived balance is assessed with Numeric Rating Scale (NRS 0-10).

  11. Perceived pain (self-reported)

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Self-reported pain is assessed both regarding intensity (Numeric Rating Scale [NRS] 0-10) and frequency.

  12. Use of pain-relieving medication (self-reported)

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Self-reported use of pain-relieving medication, including type and frequency.

  13. Fracture risk score

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Composite score based on results for balance (One-leg-standing test with eyes opened), leg muscle srength (Chair-Stand test- 30 sec), and patient-reported fall incidence during the last year.

  14. Maximal walking speed

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Walking speed assessed with patients walking 10 meters at a maximal walking speed.

  15. Hand-strength

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Assessed in sitting position with the Jamar. Values from both right and left side are assessed.

  16. Chair-Stand test (30 sec)

    Time frame: Baseline to follow-up at 3 months and 12 months.

    The maximal number of sit to stand during 30 seconds.

  17. Measure of hyperkyfosis

    Time frame: Baseline to follow-up at 3 months and 12 months.

    With patients in upright standing measuring distance between the C7 and the wall

  18. Timed-up and go (TUG)

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Patients were asked to stand up from sitting and walk 3 meters, turning around, walk back and sit again. Time was measured in seconds.

  19. Static balance

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Assessed with the One-leg-Standing test with eyes opened (OLST-EO) for both right and left legs and a maximum of 60 seconds.

  20. Dynamic balance

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Measured with the Four Square Step Test (FSST) as the time in seconds to perform a sequence that require the subject to step forward, backward, and sideway to the right and left.

Other outcomes

  1. Accelerometer-based assessment of physical activity and sedentary behaviours

    Time frame: Baseline to follow-up at 3 months and 12 months.

    Measured with ActivPAL™ accelerometers in a subset of patients during 7 days

  2. Adverse event

    Time frame: Baseline to follow-up at 3 months and 12 months

    Adverse events will be monitored throughout the study period. Self-reported adverse events related to fracture, musculoskeletal injury, falls, increased uncertainty and worry, or other health-related complaints will be collected at follow-up assessments.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Spångeus, Ass Prof MD

CONTACT

[email protected]

+46-10-1030000

Johanna Wibault, PhD

CONTACT

[email protected]

+46-10-1030000

Sponsors and collaborators

Lead sponsor

University Hospital, Linkoeping

Other

Collaborators

  • County Council of Gavleborg
  • County Council of Halland, Sweden
  • Region Jönköping County
  • Region Kalmar County
  • Sormland County Council, Sweden
  • Örebro County Council

Registry information

Official study title

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)

Acronym: RCT-PATOS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 26, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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