Using KomPas+ in the Treatment of Patients With Intermittent Claudication

Radboud University Medical Center

Status: Completed

Conditions: Intermittent Claudication; Peripheral Arterial Disease

Treatments: Device: KomPas+; Device: KomPas

Study type: Interventional

Funder types: Other

Identifiers

NCT05232474

2021-13373

Details and patient eligibility

About

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.

Enrollment: 2,271 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria Primary objective:

- All therapists affiliated with Chronisch Zorgnet and specialized in the treatment of people with intermittent claudication are eligible to participate. Besides, all patients referred to a Chronisch Zorgnet therapist with intermittent claudication specialty are eligible to participate.

Inclusion Criteria Secondary objective:

• Provides written informed consent (both therapist and patients)
• Therapists should have finished two KomPas (control group) or KomPas+ (experimental group) e-learnings
• Therapists should have applied KomPas (control group) or KomPas+ (experimental group) to at least one patient with intermittent claudication

Inclusion Criteria Third objective:

- All therapists affiliated with Chronisch Zorgnet and specialized in the treatment of people with intermittent claudication who are included in the experimental group are eligible to participate.

Exclusion Criteria:

• Not applicable due to the "real world" setting of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,271 participants in 2 patient groups

Control group: no access to KomPas+

Other group

Description:

Therapists in the control group will not have access to KomPas+ and will continue to deliver usual care by using the KNGF guideline. They will also maintain access to KomPas. As with KomPas+, therapists are free to choose whether to use KomPas or not. The use of KomPas will also be encouraged.

Treatment:

Device: KomPas

Experimental group: access to KomPas+

Experimental group

Description:

KomPas+ will be implemented within the experimental group. The use of KomPas+ in the physiotherapeutic treatment of patients with intermittent claudication will not be mandatory but will be encouraged through an implementation strategy. Therapists are free to choose whether to use it or not.

Treatment:

Device: KomPas

Device: KomPas+