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| Name | Class |
|---|---|
| Örebro County Council | OTHER_GOV |
| Region Kalmar County | OTHER |
| County Council of Halland, Sweden | OTHER_GOV |
| Sormland County Council, Sweden |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care (Control) | Active Comparator | General information on osteoporosis (open website) |
|
| Face-to-face patient education | Active Comparator | Structured group-based theoretical education ('osteoporosis school') |
|
| Digital patient education | Active Comparator | Internet-based patient education program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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). |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Spångeus, Ass Prof MD | Contact | +46-10-1030000 | anna.spangeus@liu.se | |
| Johanna Wibault, PhD | Contact | +46-10-1030000 | johanna.wibault@regionostergotland.se |
| Name | Affiliation | Role |
|---|---|---|
| Anna Spångeus, Ass Prof MD | Region Östergötland | Study Chair |
| Johanna Wibault, PhD | Region Östergötland | Principal Investigator |
| Gunnel Peterson, Assoc Prof |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Gävleborg | Not yet recruiting | Gävle | Sweden |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| OTHER |
| County Council of Gavleborg | OTHER |
| Region Jönköping County | OTHER_GOV |
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|
| 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/ ). |
|
| 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. |
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 |
| Sormland County Council, Sweden |
| Principal Investigator |
| Region Jönköpings län | Not yet recruiting | Jönköping | Sweden |
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| Region Kalmar | Recruiting | Kalmar | Sweden |
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| Region Sörmland | Recruiting | Katrineholm | Sweden |
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| Region Halland | Not yet recruiting | Kungsbacka | Sweden |
|
| Region Östergötland | Recruiting | Linköping | Sweden |
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| Region Örebro | Recruiting | Örebro | Sweden |
|
| D009750 |
| Nutritional and Metabolic Diseases |