Patient Education in Osteoporosis (RCT-PATOS)

University Hospital, Linkoeping

Status: Not yet enrolling

Conditions: Osteoporosis

Treatments: Behavioral: Digital patient education; Behavioral: General information on osteoporosis (open website); Behavioral: Face-to-face patient education

Study type: Interventional

Funder types: Other

Identifiers

NCT07367776

RCT-PATOS

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 3 patient groups

Usual care (Control)

Active Comparator group

Description:

General information on osteoporosis (open website)

Treatment:

Behavioral: General information on osteoporosis (open website)

Face-to-face patient education

Active Comparator group

Description:

Structured group-based theoretical education ('osteoporosis school')

Treatment:

Behavioral: Face-to-face patient education

Digital patient education

Active Comparator group

Description:

Internet-based patient education program

Treatment:

Behavioral: Digital patient education