Primary objective: To determine whether adding information and coaching support to the standard diagnostic testing environment for the inducibility of myocardial ischemia improves patient psychological wellbeing.The role of the testing environment…
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Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Cardiovascular disease is one of the main causes of death worldwide (Khan,
2020). One of the precursors of serious heart problems such as a heart attack
is myocardial ischemia which occurs when blood flow to the heart is reduced,
preventing enough oxygen supply to the heart muscle. Myocardial ischemia is
often caused by partial or complete blockage of the coronary arteries (coronary
artery disease: CAD). Resulting persistent cardiac symptoms, such as chest
pain, are a substantial burden to patients and society. Optimal and efficient
diagnosis of myocardial ischemia is therefore paramount. The present study
focusses on the effects of testing environment on emotion and mood states,
cardiac symptoms and patient satisfaction during cardiac stress testing in
patients that are referred to the Verbeeten Institute for SPECT MPI.
Study objective
Primary objective: To determine whether adding information and coaching
support to the standard diagnostic testing environment for the inducibility of
myocardial ischemia improves patient psychological wellbeing.
The role of the testing environment on psychological measures will be assessed
by comparing four approaches during the diagnostic project: care-as-usual
(CAU), providing information support using video clips, providing supportive
coaching by a coach, and a combination of information support and supportive
coaching. It is hypothesized that both interventions will additively improve
psychological wellbeing during the diagnostic process (i.e., emotional states
and mood).
Secondary Objectives
2.1. To determine whether adding information and coaching support to the
standard diagnostic testing environment for the inducibility of myocardial
ischemia reduces cardiac and other physical symptoms during the testing
procedure.
Previous studies have already shown a relation between negative emotions such
as anxiety with cardiac and other physical symptoms. It is therefore
hypothesized that both information and supportive coaching interventions will
additively reduce cardiac and other physical symptoms during the diagnostic
testing procedure.
2.2. To determine whether adding information and coaching support to the
standard diagnostic testing environment for the inducibility of myocardial
ischemia will improve patient satisfaction with the clinic visit.
It is hypothesized that information support and supportive coaching improves
patient satisfaction by improving psychological wellbeing (i.e., reducing
anxiety, uncertainty and distress) and reducing cardiac and other physical
symptoms during the diagnostic testing procedure.
2.3 To establish the association between patient wellbeing experiences during
the diagnostic testing procedure for inducibility of myocardial ischemia with
autonomic nervous system activity.
It is hypothesized that higher levels of psychological wellbeing are
associated with a shift towards reduced sympathetic and increased
parasympathetic autonomic nervous system activity as indexed by lower heart
rate and blood pressure responses during cardiac testing and higher levels of
heart rate variability during ambulatory ECG monitoring.
Study design
Experimental 2x2 factorial design with four groups: CAU, CAU + Information, CAU
+ Coach, CAU + Information + Coach. Outcome measures: psychological wellbeing
(primary outcome: emotional states self-report and FaceReader assessments), and
symptoms during the diagnostic testing procedure, patient satisfaction and
autonomic nervous system activity (secondary outcome measures).
Intervention
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 support by a coach and a combination
of information and emotional support. This type of intervention is intended as
quality of care evaluation. As per study protocol, participating patients will
be randomly assigned into four groups before their first clinic visit at
Institute Verbeeten.
Group 1: Care as usual (CAU) = 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.
Group 2: CAU + Information support = patients in this group will primarily
receive additional information on the diagnostic process that they will go
through with the use of video materials as well as answers to questions.
Emotional support by additional coaching will not be provided in this group.
Group 3: CAU + Supportive coaching = Patients in this group will receive
emotional support throughout their clinic visit. The coach is available for
questions as well as specific support for each patient. Additional information
using video materials will not be supplied to the patients during the
diagnostic process, but will be made available after completion of the MPI
procedures.
Group 4: CAU + Information + Coaching = Patients in this group will receive
both additional information as well as supportive coaching during their visit
of the clinic.
Study burden and risks
- Filling out one questionnaire on psychological factors, which takes
approximately 25 minutes.
- Filling out a second questionnaire on demographic and psychosocial factors in
a take-home questionnaire, and returning them by postal mail. Estimated time 25
minutes.
- Receiving two short (<5 min each) information video clips or interacting with
a coach who provides emotional support (<10 minutes total)
- Filling out a third brief questionnaire on patient experience and
satisfaction using an online questionnaire taking approximately 25 minutes.
- Use of a Holter monitor over the 24 hours after the hospital visit.
- Consent to have video recordings taken of the patient during the bicycle or
adenosine myocardial perfusion stress task. These recordings will be used to
detect facial expressions using specialized software (FaceReader) at Tilburg
University. See protocol for details. Reporting (cardiac) symptoms during the
second day of cardiac stress testing; which is part of routine clinical
practice, expanded by a scale to measure intensity of the symptoms for the
present study
- Consent to collect additional collection of data from hospital records at the
Verbeeten Institute (including blood pressure and heart rate monitoring) and
the Elisabeth-Tweesteden hospital cardiology unit.
Warandelaan 2
Tilburg 5037 AB
NL
Warandelaan 2
Tilburg 5037 AB
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL81600.028.22 |