An interventional study of Digital patient education and Face-to-face patient education in Osteoporosis, sponsored by University Hospital, Linkoeping. Recruiting at 7 sites in Sweden. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by University Hospital, Linkoeping · Not applicable, Interventional, and Supportive care
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.
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's planned enrollment of 600 is above the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →University Hospital, Linkoeping is the lead sponsor of 119 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
General information on osteoporosis (open website)
Behavioral: General information on osteoporosis (open website)
Structured group-based theoretical education ('osteoporosis school')
Behavioral: Face-to-face 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.
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.
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/ ).
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).
Time frame: Baseline to follow up at 12 months.
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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline to follow-up at 3 months and 12 months.
Patient enablement instrument (PEI)
Measured with the Patient Enablement Instrument (PEI).
Time frame: 3 months and 12 months
Fear of falling
Assessed with Falls Efficacy Scale-International (FES-I). The FES-I is a 16-item questionnaire.
Time frame: 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.
Time frame: Baseline to follow-up at 3 months and 12 months.
Beliefs about the necessity of prescribed medication
Assessed using Beliefs about Medicines Questionnaire (BMQ).
Time frame: Baseline to follow-up at 3 months and 12 months.
Physical activity (self-reported)
Measured with questions from the Swedish Questionnaire about Lifestyle Habits.
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to follow-up at 3 months and 12 months.
Accelerometer-based assessment of physical activity and sedentary behaviours
Measured with ActivPAL™ accelerometers in a subset of patients during 7 days
Time frame: 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.
Time frame: Baseline to follow-up at 3 months and 12 months
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Linkoeping →