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Optimizing patient experience during cardiac stress testing

Optimizing patient experience during cardiac stress testing - OPTIMIZE

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51832
Enrollment
180
Registered
2022-09-05
Start date
2022-11-02
Completion date
Unknown
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial ischemia. Oxygen deficiency of the heart muscle.

Interventions

To improve the patient experiences during cardiac stress testing and MPI, we will compare four approaches while patients visit the Institute Verbeeten: Care as usual, information support, emotional

Sponsors

Universiteit van Tilburg
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: All patients who are referred to the Verbeeten Institute Tilburg who are eligible for adenosine-exercise SPECT MPI, older than 18 years of age, capable of answering questionnaires and receiving information and coaching in Dutch.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Younger than 18 years of age, a life-threatening disease, and inability to fill out questionnaires or receive information or coaching in Dutch.

Design outcomes

Primary

MeasureTime frame
Primary outcome measure: Psychological wellbeing will be assessed using self-report measures of emotional states (anxiety, stress and uncertainty) and facial expression of emotions based on video recordings during the diagnostic testing procedure. Facial expressions will be analyzed (valence and intensity; e.g., anxiety) using FaceReader software as in our prior METC-approved research projects at Institute Verbeeten. These measures of psychological wellbeing will be compared between the four groups and associations with the secondary outcomes will be investigated (cardiac symptoms, patient satisfaction and stress-related autonomic nervous system measures).

Secondary

MeasureTime frame
Cardiac symptoms: Type and intensity of cardiac symptoms and other common symptoms during MPI SPECT (e.g., headache, dizziness, fatigue, nausea) will be assessed using self-report measures. Patient experience/satisfaction: Patient experience and satisfaction of the clinic visit, cardiac tests and coaching will be assessed using a validated questionnaire. Physiological measures: During the cardiac stress-test, heart rate and blood pressure are routinely collected. These data will be used as physiological measures that are relevant to emotional experiences, cardiac symptoms and inducibility of myocardial ischemia. Ambulatory ECG monitoring: A 24-hour Holter-ECG will be used to assess heart rate variability and other ECG parameters during everyday life activities. These assessments are obtained out-of-clinic during the days between the resting and stress MPI SPECT assessment and will reveal ambulatory data related to heart rate and heart rate variability. SPECT images: As part of patients clinical care, single-photon emission computed tomography will be used to obtain myocardial perfusion images on the rest and cardiac stress test days. The presence or absence of ischemia can be evaluated based on these images. During the myocardial perfusion stress-test, blood pressure and heart rate are being collected routinely. We ask patients for permission to collect these data for the present study. Blood pressure and heart rate provide additional relevant information about emotion-related physiological responses relevant to cardiac symptoms and myocardial ischemia.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)