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Implementation and Evaluation of a Guideline-based Clinical Decision Support System (KomPas+) Used by Therapists and Patients in the Treatment of Intermittent Claudication: a Cluster Randomized Trial With a Parallel Process Evaluation
Intermittent claudication is the most common symptom of peripheral arterial disease (PAD). The recommended therapy is supervised exercise therapy combined with lifestyle counselling, provided by a physiotherapist. Ideally, during the treatment process patients' values and preferences are incorporated with evidence-based knowledge; shared decision making (SDM). Evidence shows the use of SDM in daily practice is scarce. Therefore, personalized outcome forecasts which provide insight into an individual's personal prognosis (called KomPas) were implemented in 2020. Now, as a next step, KomPas is further developed into a guideline-based clinical decision support system. The result is called KomPas+, a tool which integrates the person-centered approach of KomPas with the guideline recommendations for the conservative treatment of people with intermittent claudication.The primary objective of this study is to evaluate the impact of implementing KomPas+ in the physiotherapeutic treatment of patients with intermittent claudication on functional walking distance and health-related quality of life. Secondary, the level of SDM and person-centeredness of physiotherapists using KomPas or KomPas+ will be assessed. Third, the implementation process will be evaluated.
Age
All ages
Sex
ALL
Healthy Volunteers
No
IQ healthcare, Radboudumc
Nijmegen, Netherlands
Start Date
October 1, 2022
Primary Completion Date
June 4, 2024
Completion Date
June 4, 2024
Last Updated
December 29, 2025
2,271
ACTUAL participants
KomPas+
DEVICE
KomPas
DEVICE
Lead Sponsor
Radboud University Medical Center
Collaborators
NCT07472049
NCT07161583
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07322913