Using KomPas+ in the Treatment of Patients With Intermittent Claudication

NCT05232474 | Completed

• 1 other identifier: 2021-13373
• Study Type: interventional
• Target: 2,271
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Mean Change from Baseline in Functional walking distance (FWD) using a standardized treadmill test at 3 months, 6 months, 9 months and 12 months.

  The treadmill test is based on the graded Gardner-Skinner protocol. FWD is defined as the distance at which the patient would prefer to stop walking in daily life.

  Change from baseline at 3 months and 6 months

• Mean Change from Baseline in Health-Related Quality of Life using the Vascular Quality of Life Questionnaire-6 (VascuQol-6) at 3 months, 6 months, 9 months and 12 months.

  The VascuQol-6 consists of six questions related to activities, symptom burden, pain, emotions and social consequences. The score ranges from 6 to 24, with a higher score representing a better quality of life.

  Change from baseline at 3 months and 6 months

Secondary Outcomes (2)

• Level of Person-Centredness assessed by using a Patient-Administered Questionnaire at the initial consult with the patient with intermittent claudication in which treatment goals and treatment plan are discussed.

  During the initial consult with the patient with intermittent claudication in which treatment goals and treatment plan are discussed. This moment varies between the date of inclusion to three weeks after the date of inclusion.

• Level of Shared Decision Making (SDM) assessed by scoring video-records of clinical consultations with the Observer Patient Involvement (OPTION) 5 scale at the initial consult with the patient in which treatment goals and treatment plan are discussed.

  During the initial consult with the patient with intermittent claudication in which treatment goals and treatment plan are discussed. This moment varies between the date of inclusion to three weeks after the date of inclusion.

Other Outcomes (2)

• Perceived barriers and facilitators to (not) use KomPas+ in the physiotherapeutic treatment of patients with intermittent claudication using a qualitative assessment.

  Between six and twelve months after the start of the implementation of KomPas+

• The degree of implementation of KomPas+ in terms of reach and demand measured by website logs (demand) and the use of KomPas+ (reach).

  After the 4-month inclusion period

Study Arms (2)

Control group: no access to KomPas+

OTHER

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.

Device: KomPas

Experimental group: access to KomPas+

EXPERIMENTAL

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.

Device: KomPas+; Device: KomPas

Interventions

KomPas 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.

Control group: no access to KomPas+; Experimental group: access to KomPas+

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator
• Chronisch ZorgNet: collaborator
• Koninklijk Nederlands Genootschap voor Fysiotherapie: collaborator
• Vereniging van Oefentherapeuten Cesar en Mensendieck: collaborator
• Harteraad: collaborator

Study Sites (1)

IQ healthcare, Radboudumc

Nijmegen, 6525 EP, Netherlands

Location

MeSH Terms

Conditions

Intermittent Claudication; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Thomas Hoogeboom, PhD

  Radboud university medical center, IQ healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 9, 2022
• Study Start: October 1, 2022
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: December 29, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)