Clinical trial NCT05896982: Optimizing Patient Experience During Myocardial Perfusion Imaging
Official title: Optimizing Patient Experience During Myocardial Perfusion Imaging
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myocardial Ischemia
Myocardial Infarction
Autonomic Dysfunction
Lead sponsor: Tilburg University
Sponsor class: OTHER
Collaborators: name: Institute Verbeeten Tilburg
name: ETZ TweeSteden Hospital Tilburg
First posted: 2023-06-09
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Experimental 2x2 factorial design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study focusses on the effects of the diagnostic testing environment on psychological wellbeing, cardiac symptoms and patient satisfaction during cardiac stress testing (CST) in patients who are referred to the Institute Verbeeten for SPECT myocardial perfusion imaging (MPI).

The diagnostic procedure consists of two days of MPI using SPECT: day 1 of MPI involves obtaining a resting image and day 2 (typically 3 or 4 days later) a stress MPI following exercise or pharmacological challenge with adenosine. The diagnostic procedure can result in undesirable effects on psychological wellbeing, such as anxiety or psychological distress. These effects can be related to anticipatory anxiety (day 1 of MPI) and/or responses to the exercise or adenosine stress testing (day 2 of MPI). The present investigation aims to develop methods to further improve patients' experiences and wellbeing during the diagnostic process for the presence of inducible myocardial ischemia.

This research project will compare four groups to establish the effect of providing information and supportive coaching: (1) care as usual, (2) information support using video materials, (3) supportive coaching during the diagnostic testing procedure, and (4) a combination of both interventions. The video-based information and supportive coaching are aimed at reducing feelings of anxiety, uncertainty and psychological distress during the diagnostic testing procedure. In addition to standardized self-report questionnaires, this project will utilize facial expression analysis software to measure emotional states during CST as well as 24- hour ambulatory assessments to evaluate autonomic nervous system activity, cardiac symptoms and psychological wellbeing during everyday life activities in the period between the two days of MPI. It is hypothesized that additional video-based information and supportive coaching during the diagnostic process for the inducibility of myocardial ischemia will result in improved psychological wellbeing (reduced acute negative emotions; primary outcome) as well as less cardiac and other physical symptoms and improved patient satisfaction (secondary outcomes) of the diagnostic clinic visit. The innovative aspect of the present proposal is its focus on emotional expression during evaluation for myocardial ischemia using FaceReader software in combination with self-reported momentary mood and perceived stress assessments. Knowledge about the interaction between psychological wellbeing and cardiac function obtained in this project will strengthen the development of future interventions aimed to reduce symptom burden and psychological distress in patients undergoing diagnostic evaluations for heart disease.


Eligibility criteria: Inclusion Criteria:

* referred to the Institute Verbeeten Tilburg and eligible for adenosine-exercise SPECT MPI
* capable of answering questionnaires and receiving information and coaching in Dutch.

Exclusion Criteria:

* a life-threatening disease with \< 1 year survival (e.g., metastatic cancer)
* refusal to informed consent.

Primary outcomes:
measure: Psychological wellbeing - self report using Profile of Mood States
timeFrame: During the two day diagnostic process.
measure: Psychological wellbeing - Facial expressions of emotions
timeFrame: During the stress test on day 2.
Secondary outcomes:
measure: Cardiac symptoms
timeFrame: During the two day diagnostic process.
measure: Patient experience - PSQ-18
timeFrame: At the end of the two day diagnostic process.
measure: Physiological measures - heart rate
timeFrame: During the cardiac stress test on the second day of the diagnostic process.
measure: Physiological measure - blood pressure
timeFrame: During the cardiac stress test on the second day of the diagnostic process.
measure: Ambulatory ECG monitoring
timeFrame: For 24 hours between the first and second day of the diagnostic process.
measure: SPECT images
timeFrame: At the end of the first and second day of the diagnostic process.
Other outcomes:
Locations:
city: Tilburg
country: Netherlands
facility: Institute Verbeeten
state: Noord-Brabant
Study officials:
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