Osteoporosis
Conditions
Keywords
osteoporosis, patient education, self-care, health related quality of life, HRQoL, internetbased, digital
Brief summary
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.
Interventions
BEHAVIORALDigital 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.
BEHAVIORALFace-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.
BEHAVIORALGeneral 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/ ).
Sponsors
University Hospital, Linkoeping
Örebro County Council
Region Kalmar County
County Council of Halland, Sweden
Sormland County Council, Sweden
County Council of Gavleborg
Region Jönköping County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 12 months) | 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
| Measure | Time frame | Description |
|---|---|---|
| Timed-up and go (TUG) | 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. |
| Static balance | 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. |
| Dynamic balance | 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. |
| Hand-strength | 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. |
| Chair-Stand test (30 sec) | Baseline to follow-up at 3 months and 12 months. | The maximal number of sit to stand during 30 seconds. |
| Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 3 months) | 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). |
| Health-related quality of life (HRQoL) - RAND-36 | 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. |
| Health-related quality of life (HRQoL) - EQ-5D-5L | 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. |
| Patient enablement instrument (PEI) | 3 months and 12 months | Measured with the Patient Enablement Instrument (PEI). |
| Fear of falling | 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. |
| Illness perception | Baseline to follow-up at 3 months and 12 months. | Assessed with the Brief-Illness Perception Questionnaire BIPQ which is an 8-item questionnaire. |
| Beliefs about the necessity of prescribed medication | Baseline to follow-up at 3 months and 12 months. | Assessed using Beliefs about Medicines Questionnaire (BMQ). |
| Physical activity (self-reported) | Baseline to follow-up at 3 months and 12 months. | Measured with questions from the Swedish Questionnaire about Lifestyle Habits. |
| Fall incidence (self-reported) | Baseline to follow-up at 3 months and 12 months. | Self-reported numbers of fall during the last 3 and 12 months |
| Perceived balance (self-reported) | Baseline to follow-up at 3 months and 12 months. | Self-rated perceived balance is assessed with Numeric Rating Scale (NRS 0-10). |
| Perceived pain (self-reported) | 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. |
| Use of pain-relieving medication (self-reported) | Baseline to follow-up at 3 months and 12 months. | Self-reported use of pain-relieving medication, including type and frequency. |
| Fracture risk score | 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. |
| Measure of hyperkyfosis | Baseline to follow-up at 3 months and 12 months. | With patients in upright standing measuring distance between the C7 and the wall |
| Maximal walking speed | Baseline to follow-up at 3 months and 12 months. | Walking speed assessed with patients walking 10 meters at a maximal walking speed. |
Countries
Sweden
Contacts
CONTACTAnna Spångeus, Ass Prof MD
CONTACTJohanna Wibault, PhD
STUDY_CHAIRAnna Spångeus, Ass Prof MD
Region Östergötland
PRINCIPAL_INVESTIGATORJohanna Wibault, PhD
Region Östergötland
PRINCIPAL_INVESTIGATORGunnel Peterson, Assoc Prof
Sormland County Council, Sweden
Outcome results
None listed