NCT05232474

Using KomPas+ in the Treatment of Patients With Intermittent Claudication

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,271 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Intermittent Claudication
• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	KomPas+	KomPas+ is a guideline-based clinical decision support system. With KomPas+, the aim is to integrate KomPas with the guideline recommendations for the conservative treatment process of patients with intermittent claudication. KomPas+ is a web-based tool, aimed to facilitate person-centered and participatory healthcare. Therapists have access to a tool that will help, for example, to improve consistency between patient-specific goals and the treatment plan. Using KomPas+, therapists are encouraged to discuss choices in the treatment plan with the patient. It is expected that the included topics in KomPas+ will not be burdensome for both patients and therapists. Topics to discuss are, for example, Frequency, Intensity, Time and Type (FITT) for drawing up a training schedule. KomPas+ is meant to facilitate therapists and patients in the SDM process. It does not force patients to take part in the SDM process against their will.
DEVICE	KomPas	KomPas is an online tool showing personalized outcome forecasts. These forecasts have been developed using real-world data of patients with intermittent claudication for physiotherapists in daily practice. The forecasts visualize the estimated outcome of supervised exercise therapy (walking distance and quality of life), for an individual patient with intermittent claudication. The information provided is based on patients similar to the individual patient from a large database. The actual outcome data of these similar patients are used to create an individual forecast. KomPas plots the estimated therapy outcome in time, thereby making personalized outcome forecasts. The forecasts are not used to direct the choices of treatment, but to motivate the patient, monitor the treatment process and to set realistic goals.

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-06-04
• Completion: 2024-06-04
• First posted: 2022-02-09
• Last updated: 2025-12-29

Locations

1 site across 1 country: Netherlands