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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
600
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/ ).
Region Gävleborg
Gävle, Sweden
RECRUITINGRegion Jönköpings län
Jönköping, Sweden
RECRUITINGRegion Kalmar
Kalmar, Sweden
RECRUITINGRegion Sörmland
Katrineholm, Sweden
RECRUITINGRegion Halland
Kungsbacka, Sweden
NOT_YET_RECRUITINGRegion Östergötland
Linköping, Sweden
RECRUITINGRegion Örebro
Örebro, Sweden
RECRUITINGOsteoporosis 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.
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