Patient Education in Osteoporosis (RCT-PATOS)

Official title

Effects and Mechanisms of Patient Education in Osteoporosis: A Randomized Controlled Trial Comparing Digital Education, Face-to-Face Education, and General Patient Information (RCT-PATOS)

Overview

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

• 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 wi
• Behavioral Face-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.
• Behavioral General 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/ ).

Primary outcome measures

• Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 12 months) [Time frame: Baseline to follow up at 12 months.]

Secondary outcome measures (12)

• Osteoporosis specific self-care - OsCare Questionnaire (baseline to follow up at 3 months) [Time frame: Baseline to follow-up at 3 months.]
• Health-related quality of life (HRQoL) - RAND-36 [Time frame: Baseline to follow-up at 3 months and 12 months.]
• Health-related quality of life (HRQoL) - EQ-5D-5L [Time frame: Baseline to follow-up at 3 months and 12 months.]
• Patient enablement instrument (PEI) [Time frame: 3 months and 12 months]
• Fear of falling [Time frame: Baseline to follow-up at 3 months and 12 months.]
• Illness perception [Time frame: Baseline to follow-up at 3 months and 12 months.]
• Beliefs about the necessity of prescribed medication [Time frame: Baseline to follow-up at 3 months and 12 months.]
• Physical activity (self-reported) [Time frame: Baseline to follow-up at 3 months and 12 months.]
• Fall incidence (self-reported) [Time frame: Baseline to follow-up at 3 months and 12 months.]
• Perceived balance (self-reported) [Time frame: Baseline to follow-up at 3 months and 12 months.]
• Perceived pain (self-reported) [Time frame: Baseline to follow-up at 3 months and 12 months.]
• Use of pain-relieving medication (self-reported) [Time frame: Baseline to follow-up at 3 months and 12 months.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Sweden · 7 centers

• Region Gävleborg — Gävle
• Region Jönköpings län — Jönköping
• Region Kalmar — Kalmar
• Region Sörmland — Katrineholm
• Region Halland — Kungsbacka
• Region Östergötland — Linköping
• Region Örebro — Örebro

Identifiers

NCT: NCT07367776 · RCT-PATOS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗