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Study Orthopedic Footwear Adherence (SOFA)

Adherence Monitoring in Orthopedic Footwear

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21554
Enrollment
1000
Registered
2017-01-16
Start date
2017-01-17
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Studied health conditions: Diabetes Mellitus, rheumatoid disorders, degenerative foot deformities, central neurologic disorders ,and other pathologies

Interventions

: 300 participants are included in the intervention study: 100 in the control group without knowledge about the actual purpose of the study (adherence monitoring based on temperature data inside the s

Sponsors

University Medical Center Groningen T. Lutjeboer, MSc. Prof. dr. K. Postema
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Patients with a prescription for their first pair of OS • Mentally competent (“wilsbekwaam”) • Aged 18 years and older. • Able to read and speak Dutch

Exclusion criteria

Exclusion criteria: • Previous experience with OS. • Mentally incompetent. • Aged 17 years old or younger.

Design outcomes

Primary

MeasureTime frame
The objective of the intervention study is to examine whether a simple intervention (knowledge about the actual purpose of the study (monitoring adherence) and feedback on their actual use of OS compared to the intended use of OS) has an effect on the patient’s use of OS. The objective of the longitudinal study is to objectively evaluate the adherence of use of OS in a population with various pathologies over a period of 18 months.

Secondary

MeasureTime frame
The secondary objectives of both studies is to identify factors that influence the adherence of use of OS. The number of OS adjustments, the use of diaries and a questionnaire (MOS) about use and usability of OS will be assessed.

Contacts

Public ContactThijs Lutjeboer
t.lutjeboer@umcg.nl+31642382501

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)