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Optimizing Patient Experience During Myocardial Perfusion Imaging (OPTIMIZE)

Primary Purpose

Myocardial Ischemia, Myocardial Infarction, Autonomic Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Care as usual with information support
Care as usual with supportive coaching
Care as usual with information support and supportive coaching
Sponsored by
Tilburg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myocardial Ischemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institute VerbeetenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Care as usual

Care as usual with information support

Care as usual with supportive coaching

Care as usual with information support and supportive coaching

Arm Description

Patients in this group will not receive any additional information materials or support on top of care as usual, but information videos will be made available after completion of the MPI procedures.

Patients in this group will primarily receive additional information on the diagnostic process that they will go through with the use of video materials. Supportive coaching will not be provided in this group.

Patients in this group will receive supportive coaching throughout their clinic visit. The coach is available for questions as well as specific support for each patient. Information support using video materials will not be supplied to the patients during the diagnostic process in this group, but will be made available after completion of the MPI procedures.

Patients in this group will receive both information support as well as supportive coaching during their diagnostic clinic visit.

Outcomes

Primary Outcome Measures

Psychological wellbeing - self report using Profile of Mood States
Will be assessed using self-report measures of emotional states on a scale from 0 to 10 (stressed, anxious, insecure, relaxed, worried, irritated, excited, and tired) with a higher score representing more of this emotional state.These measures of psychological well-being will be compared between the four groups.
Psychological wellbeing - Facial expressions of emotions
Will be assessed using 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. A value between 0 and 1 will be the outcome measure for each emotion (happy, sad, angry, surprised, scared, disgusted and neutral). These measures of psychological well-being will be compared between the four groups.

Secondary Outcome Measures

Cardiac symptoms
The intensity of cardiac symptoms and other common symptoms during MPI SPECT (e.g., headache, dizziness, fatigue, nausea) will be assessed using self-report measures on a scale from 0 to 10. Higher scores represent a higher intensity of the symptoms.
Patient experience - PSQ-18
Patient experience and satisfaction of the clinic visit, cardiac tests, and coaching will be assessed using a validated questionnaire with a higher score representing a better patient experience.
Physiological measures - heart rate
During the cardiac stress test, heart rate is routinely collected. This data will be used as a physiological measure that is relevant to emotional experiences, cardiac symptoms, and the inducibility of myocardial ischemia.
Physiological measure - blood pressure
During the cardiac stress test, blood pressure is routinely collected. This data will be used as a physiological measure that is relevant to emotional experiences, cardiac symptoms, and the inducibility of myocardial ischemia.
Ambulatory ECG monitoring
A 24-hour Holter-ECG will be used to assess heart rate variability during everyday life activities. These assessments are obtained out-of-clinic during the day between the resting and stress MPI SPECT assessment.
SPECT images
As part of the patient's 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.

Full Information

First Posted
March 15, 2023
Last Updated
May 31, 2023
Sponsor
Tilburg University
Collaborators
Institute Verbeeten Tilburg, ETZ TweeSteden Hospital Tilburg
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1. Study Identification

Unique Protocol Identification Number
NCT05896982
Brief Title
Optimizing Patient Experience During Myocardial Perfusion Imaging
Acronym
OPTIMIZE
Official Title
Optimizing Patient Experience During Myocardial Perfusion Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tilburg University
Collaborators
Institute Verbeeten Tilburg, ETZ TweeSteden Hospital Tilburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Myocardial Infarction, Autonomic Dysfunction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Experimental 2x2 factorial design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Care as usual
Arm Type
No Intervention
Arm Description
Patients in this group will not receive any additional information materials or support on top of care as usual, but information videos will be made available after completion of the MPI procedures.
Arm Title
Care as usual with information support
Arm Type
Experimental
Arm Description
Patients in this group will primarily receive additional information on the diagnostic process that they will go through with the use of video materials. Supportive coaching will not be provided in this group.
Arm Title
Care as usual with supportive coaching
Arm Type
Experimental
Arm Description
Patients in this group will receive supportive coaching throughout their clinic visit. The coach is available for questions as well as specific support for each patient. Information support using video materials will not be supplied to the patients during the diagnostic process in this group, but will be made available after completion of the MPI procedures.
Arm Title
Care as usual with information support and supportive coaching
Arm Type
Experimental
Arm Description
Patients in this group will receive both information support as well as supportive coaching during their diagnostic clinic visit.
Intervention Type
Other
Intervention Name(s)
Care as usual with information support
Intervention Description
Comprises of additional visual information in the form of two videos that show details about the procedure on both days of the MPI diagnostic procedure. Each of these two videos are approximately 5 minutes long and are made available to the patients before the first day (video 1), and in between the first and second day (video 2).
Intervention Type
Other
Intervention Name(s)
Care as usual with supportive coaching
Intervention Description
Patients receive coaching from one person who is present throughout the complete diagnostic process. The coach is available for answering questions as well as comforting the patients when necessary (e.g., to reassure patients if they are anxious or stressed).
Intervention Type
Other
Intervention Name(s)
Care as usual with information support and supportive coaching
Intervention Description
This intervention comprises additional visual information in the form of two videos and coaching throughout the diagnostic process as described above.
Primary Outcome Measure Information:
Title
Psychological wellbeing - self report using Profile of Mood States
Description
Will be assessed using self-report measures of emotional states on a scale from 0 to 10 (stressed, anxious, insecure, relaxed, worried, irritated, excited, and tired) with a higher score representing more of this emotional state.These measures of psychological well-being will be compared between the four groups.
Time Frame
During the two day diagnostic process.
Title
Psychological wellbeing - Facial expressions of emotions
Description
Will be assessed using 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. A value between 0 and 1 will be the outcome measure for each emotion (happy, sad, angry, surprised, scared, disgusted and neutral). These measures of psychological well-being will be compared between the four groups.
Time Frame
During the stress test on day 2.
Secondary Outcome Measure Information:
Title
Cardiac symptoms
Description
The intensity of cardiac symptoms and other common symptoms during MPI SPECT (e.g., headache, dizziness, fatigue, nausea) will be assessed using self-report measures on a scale from 0 to 10. Higher scores represent a higher intensity of the symptoms.
Time Frame
During the two day diagnostic process.
Title
Patient experience - PSQ-18
Description
Patient experience and satisfaction of the clinic visit, cardiac tests, and coaching will be assessed using a validated questionnaire with a higher score representing a better patient experience.
Time Frame
At the end of the two day diagnostic process.
Title
Physiological measures - heart rate
Description
During the cardiac stress test, heart rate is routinely collected. This data will be used as a physiological measure that is relevant to emotional experiences, cardiac symptoms, and the inducibility of myocardial ischemia.
Time Frame
During the cardiac stress test on the second day of the diagnostic process.
Title
Physiological measure - blood pressure
Description
During the cardiac stress test, blood pressure is routinely collected. This data will be used as a physiological measure that is relevant to emotional experiences, cardiac symptoms, and the inducibility of myocardial ischemia.
Time Frame
During the cardiac stress test on the second day of the diagnostic process.
Title
Ambulatory ECG monitoring
Description
A 24-hour Holter-ECG will be used to assess heart rate variability during everyday life activities. These assessments are obtained out-of-clinic during the day between the resting and stress MPI SPECT assessment.
Time Frame
For 24 hours between the first and second day of the diagnostic process.
Title
SPECT images
Description
As part of the patient's 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.
Time Frame
At the end of the first and second day of the diagnostic process.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Roovers, MSc
Phone
+31627180434
Email
t.roovers_1@tilburguniversity.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Willem J Kop, PhD
Email
W.J.Kop@tilburguniversity.edu
Facility Information:
Facility Name
Institute Verbeeten
City
Tilburg
State/Province
Noord-Brabant
ZIP/Postal Code
5042 SB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Roovers, MSc
Email
t.roovers_1@tilburguniversity.edu
First Name & Middle Initial & Last Name & Degree
Ilse Vermeltfoort, PhD
Email
vermeltfoort.i@bvi.nl

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
10331526
Citation
Adelstein SJ. Administered radionuclides in pregnancy. Teratology. 1999 Apr;59(4):236-9. doi: 10.1002/(SICI)1096-9926(199904)59:43.0.CO;2-6.
Results Reference
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PubMed Identifier
28810432
Citation
Baik SH, Fox RS, Mills SD, Roesch SC, Sadler GR, Klonoff EA, Malcarne VL. Reliability and validity of the Perceived Stress Scale-10 in Hispanic Americans with English or Spanish language preference. J Health Psychol. 2019 Apr;24(5):628-639. doi: 10.1177/1359105316684938. Epub 2017 Jan 5.
Results Reference
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PubMed Identifier
35420591
Citation
Bekendam MT, Mommersteeg PMC, Vermeltfoort IAC, Widdershoven JW, Kop WJ. Facial Emotion Expression and the Inducibility of Myocardial Ischemia During Cardiac Stress Testing: The Role of Psychological Background Factors. Psychosom Med. 2022 Jun 1;84(5):588-596. doi: 10.1097/PSY.0000000000001085. Epub 2022 Apr 14.
Results Reference
background
PubMed Identifier
33025473
Citation
Bekendam MT, Vermeltfoort IAC, Kop WJ, Widdershoven JW, Mommersteeg PMC. Psychological factors of suspect coronary microvascular dysfunction in patients undergoing SPECT imaging. J Nucl Cardiol. 2022 Apr;29(2):768-778. doi: 10.1007/s12350-020-02360-5. Epub 2020 Oct 6.
Results Reference
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PubMed Identifier
33619698
Citation
Bekendam MT, Kop WJ, Vermeltfoort IAC, Widdershoven JW, Mommersteeg PMC. Facial Expressions of Emotions During Pharmacological and Exercise Stress Testing: the Role of Myocardial Ischemia and Cardiac Symptoms. Int J Behav Med. 2021 Dec;28(6):692-704. doi: 10.1007/s12529-021-09963-3. Epub 2021 Feb 23.
Results Reference
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PubMed Identifier
32112295
Citation
Bekendam MT, Mommersteeg PMC, Kop WJ, Widdershoven JW, Vermeltfoort IAC. Anxiety and hemodynamic reactivity during cardiac stress testing: The role of gender and age in myocardial ischemia. J Nucl Cardiol. 2021 Dec;28(6):2581-2592. doi: 10.1007/s12350-020-02079-3. Epub 2020 Feb 28.
Results Reference
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PubMed Identifier
8606268
Citation
Gabbay FH, Krantz DS, Kop WJ, Hedges SM, Klein J, Gottdiener JS, Rozanski A. Triggers of myocardial ischemia during daily life in patients with coronary artery disease: physical and mental activities, anger and smoking. J Am Coll Cardiol. 1996 Mar 1;27(3):585-92. doi: 10.1016/0735-1097(95)00510-2.
Results Reference
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Optimizing Patient Experience During Myocardial Perfusion Imaging

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