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)

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoporosis
• Intervention / Treatment: Behavioral: General information on osteoporosis (open website); Behavioral: Face-to-face patient education; Behavioral: Digital patient education

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Spångeus, Ass Prof MD; Phone Number: +46-10-1030000; Email: anna.spangeus@liu.se
• Study Contact Backup: Name: Johanna Wibault, PhD; Phone Number: +46-10-1030000; Email: johanna.wibault@regionostergotland.se

Study Locations

• Sweden
  • Gävle, Sweden
    • Not yet recruiting
    • Region Gävleborg
    • Contact: Research coordinator at Linköpings University Hospital; Phone Number: +46-10-1030000; Email: osteoporosforskning@regionostergotland.se
  • Jönköping, Sweden
    • Not yet recruiting
    • Region Jönköpings län
    • Contact: Research coordinator at Linköpings University Hospital; Phone Number: +46-10-1030000; Email: osteoporosforskning@regionostergotland.se
  • Kalmar, Sweden
    • Recruiting
    • Region Kalmar
    • Contact: Research coordinator at Linköpings University Hospital; Phone Number: +46-10-1030000; Email: osteoporosforskning@regionostergotland.se
  • Katrineholm, Sweden
    • Recruiting
    • Region Sörmland
    • Contact: Research coordinator at Linköpings University Hospital; Phone Number: +46-10-1030000; Email: osteoporosforskning@regionostergotland.se
  • Kungsbacka, Sweden
    • Not yet recruiting
    • Region Halland
    • Contact: Research coordinator at Linköpings University Hospital; Phone Number: +46-10-1030000; Email: osteoporosforskning@regionostergotland.se
  • Linköping, Sweden
    • Recruiting
    • Region Östergötland
    • Contact: Research coordinator at Linköpings University Hospital; Phone Number: +46-10-1030000; Email: osteoporosforskning@regionostergotland.se
  • Örebro, Sweden
    • Recruiting
    • Region Örebro
    • Contact: Research coordinator at Linköpings University Hospital; Phone Number: +46-10-1030000; Email: osteoporosforskning@regionostergotland.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care (Control); General information on osteoporosis (open website)	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/ ).
Active Comparator: Face-to-face patient education; Structured group-based theoretical education ('osteoporosis school')	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.
Active Comparator: Digital patient education; Internet-based patient education program	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Osteoporosis specific self-care - OsCare Questionnaire (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).	Baseline to follow-up at 3 months.
Health-related quality of life (HRQoL) - RAND-36	Assessed with RAND 36-Item Health Survey. The RAND-36 compromises 36 items covering 8 health-related domains.	Baseline to follow-up at 3 months and 12 months.
Health-related quality of life (HRQoL) - EQ-5D-5L	Assessed with the EuroQol 5 Dimensions (EQ5D-5L) and Visual Analogue Scale (VAS 0-100) where respondents rate their overall health.	Baseline to follow-up at 3 months and 12 months.
Patient enablement instrument (PEI)	Measured with the Patient Enablement Instrument (PEI).	3 months and 12 months
Fear of falling	Assessed with Falls Efficacy Scale-International (FES-I). The FES-I is a 16-item questionnaire.	Baseline to follow-up at 3 months and 12 months.
Illness perception	Assessed with the Brief-Illness Perception Questionnaire BIPQ which is an 8-item questionnaire.	Baseline to follow-up at 3 months and 12 months.
Beliefs about the necessity of prescribed medication	Assessed using Beliefs about Medicines Questionnaire (BMQ).	Baseline to follow-up at 3 months and 12 months.
Physical activity (self-reported)	Measured with questions from the Swedish Questionnaire about Lifestyle Habits.	Baseline to follow-up at 3 months and 12 months.
Fall incidence (self-reported)	Self-reported numbers of fall during the last 3 and 12 months	Baseline to follow-up at 3 months and 12 months.
Perceived balance (self-reported)	Self-rated perceived balance is assessed with Numeric Rating Scale (NRS 0-10).	Baseline to follow-up at 3 months and 12 months.
Perceived pain (self-reported)	Self-reported pain is assessed both regarding intensity (Numeric Rating Scale [NRS] 0-10) and frequency.	Baseline to follow-up at 3 months and 12 months.
Use of pain-relieving medication (self-reported)	Self-reported use of pain-relieving medication, including type and frequency.	Baseline to follow-up at 3 months and 12 months.
Fracture risk score	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.	Baseline to follow-up at 3 months and 12 months.
Maximal walking speed	Walking speed assessed with patients walking 10 meters at a maximal walking speed.	Baseline to follow-up at 3 months and 12 months.
Hand-strength	Assessed in sitting position with the Jamar. Values from both right and left side are assessed.	Baseline to follow-up at 3 months and 12 months.
Chair-Stand test (30 sec)	The maximal number of sit to stand during 30 seconds.	Baseline to follow-up at 3 months and 12 months.
Measure of hyperkyfosis	With patients in upright standing measuring distance between the C7 and the wall	Baseline to follow-up at 3 months and 12 months.
Timed-up and go (TUG)	Patients were asked to stand up from sitting and walk 3 meters, turning around, walk back and sit again. Time was measured in seconds.	Baseline to follow-up at 3 months and 12 months.
Static balance	Assessed with the One-leg-Standing test with eyes opened (OLST-EO) for both right and left legs and a maximum of 60 seconds.	Baseline to follow-up at 3 months and 12 months.
Dynamic balance	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.	Baseline to follow-up at 3 months and 12 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accelerometer-based assessment of physical activity and sedentary behaviours	Measured with ActivPAL™ accelerometers in a subset of patients during 7 days	Baseline to follow-up at 3 months and 12 months.
Adverse event	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.	Baseline to follow-up at 3 months and 12 months

Collaborators and Investigators

• Sponsor: University Hospital, Linkoeping
• Collaborators: Örebro County Council; Region Jönköping County; County Council of Halland, Sweden; Sormland County Council, Sweden; Kalmar County Council; County Council of Gavleborg
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2026
• Primary Completion (Estimated): October 20, 2028
• Study Completion (Estimated): October 20, 2028

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: January 19, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: patient education; osteoporosis; health related quality of life; self-care; HRQoL; digital; internetbased
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Osteoporosis
• Other Study ID Numbers: RCT-PATOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No