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Using KomPas+ in the Treatment of Patients With Intermittent Claudication

NCT ID: NCT05232474

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2024-06-04

Brief Summary

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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.

Detailed Description

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Conditions

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Intermittent Claudication Peripheral Arterial Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group: no access to KomPas+

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.

Group Type OTHER

KomPas

Intervention Type DEVICE

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.

Experimental group: access to KomPas+

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.

Group Type EXPERIMENTAL

KomPas+

Intervention Type DEVICE

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.

KomPas

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- 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.


* 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


\- 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Chronisch ZorgNet

UNKNOWN

Sponsor Role collaborator

Koninklijk Nederlands Genootschap voor Fysiotherapie

UNKNOWN

Sponsor Role collaborator

Vereniging van Oefentherapeuten Cesar en Mensendieck

UNKNOWN

Sponsor Role collaborator

Harteraad

UNKNOWN

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Hoogeboom, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud university medical center, IQ healthcare

Locations

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IQ healthcare, Radboudumc

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2021-13373

Identifier Type: -

Identifier Source: org_study_id