Using KomPas+ in the Treatment of Patients With Intermittent Claudication
- Conditions
- Intermittent ClaudicationPeripheral Arterial Disease
- Interventions
- Device: KomPas+Device: KomPas
- Registration Number
- NCT05232474
- Lead Sponsor
- Radboud University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 904
Not provided
- Not applicable due to the "real world" setting of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group: access to KomPas+ 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. Control group: no access to KomPas+ 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. Experimental group: access to KomPas+ 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.
- Primary Outcome Measures
Name Time Method Mean Change from Baseline in Functional walking distance (FWD) using a standardized treadmill test at 3 months, 6 months, 9 months and 12 months. Change from baseline at 3 months and 6 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.
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. Change from baseline at 3 months and 6 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.
- Secondary Outcome Measures
Name Time Method 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. The used questions are part of the 36-item patient-centered primary care (PCPC) instrument.This Dutch instrument is specifically developed to assess person centered care in primary care setting for patients with multimorbidity. The complete PCPC instrument consists of 36 items divided over eight domains which are based on the eight dimensions of person centered care identified by the Picker Institute. For this study, the seven questions which form the subdomain 'Patients' preferences' are used. For example, patients will be asked if they felt taken seriously, if their wishes and preferences were taken into account and if they were involved in decisions about their treatment. Each of the seven questions will be responded by a five-point scale ranging from 1 (totally disagree) to 5 (totally agree) resulting in a total score between 7 and 35.
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. The five items of the OPTION-5 are based on the five core dimensions of SDM: alternate options (item 1), forming a partnership (item 2), inform about options (item 3), eliciting preferences (item 4), and integrate preferences (item 5). Each item will be scored on a five-point Likert scale from 0 (no effort) to 4 (exemplary effort) to obtain objective data of the SDM process. Item scores will be summed so that the potential total score is between 0 and 20. The total score will be rescaled to lie between 0 and 100.
Trial Locations
- Locations (1)
IQ healthcare, Radboudumc
🇳🇱Nijmegen, Netherlands