About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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/ ).

Treatment groups

600 Participants

are divided into 3 treatment groups

Group A: Usual care (Control)Active comparator 1 intervention

Group B: Face-to-face patient educationActive comparator 1 intervention

Group C: Digital patient educationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.

2

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.

3

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.

4

Patient enablement instrument (PEI)

Measured with the Patient Enablement Instrument (PEI).

Time frame

3 months and 12 months

Other outcomes

1

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.

2

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

Patient Education in Osteoporosis (RCT-PATOS)

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts