Using KomPas+ in the Treatment of Patients With Intermittent Claudication (NCT05232474) | Clinical Trial Compass
CompletedNot Applicable
Using KomPas+ in the Treatment of Patients With Intermittent Claudication
Netherlands2,271 participantsStarted 2022-10-01
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean Change from Baseline in Functional walking distance (FWD) using a standardized treadmill test at 3 months, 6 months, 9 months and 12 months.
Timeframe: Change from baseline at 3 months and 6 months
2
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.
Timeframe: Change from baseline at 3 months and 6 months