Effect of Mindfulness-based eHealth Cardiac Rehabilitation on Psychological Wellbeing and Risk Factor Management of Patients With Coronary Heart Disease: A Randomized Controlled Trial
Phase: NA
Conditions: Coronary Heart Disease (CHD)
Sponsor: Tung Wah College

Cover page 
Official title: Effect of mindfulness-based eHealth cardiac rehabilitation on 
psychological wellbeing and risk factor management for patients with coronary heart 
disease: A randomized controlled trial 
 
NCT number: not yet assigned  
Document date: July 17, 2024 
 
 

1. Purpose of the study 
The purpose of this study is to test the effect of eHealth cardiac rehabilitation 
incorporating mindfulness as a stress management component for people with coronary 
heart disease (CHD). CHD is a leading cause of death globally, including in Hong Kong, 
and its prevalence is expected to increase due to the aging population and stressful modern 
lifestyles.  With the widespread use of information and community technology, eHealth 
cardiac rehabilitation (CR) is recognized as an effective, safe, and cost-saving alternative 
to improve traditional CR accessibility and improve patient outcomes. However, the stress 
management component is under-addressed; there is a lack of integrating evidence-based 
psychological therapy and insufficient involvement of mental health professionals in 
eHealth CR. This is a pressing concern as more than half of People with CHD reported a 
significant level of psychological stress which can trigger acute cardiac events or increase 
the chance of cardiac events. To resolve this critical gap, the proposed study aims to test 
the effect of a comprehensive eHealth CR program that incorporates mindfulness as a stress 
management component for people with CHD.  
 
5. Methods: 
a. Research Design 
 
The proposed project is a single-blinded, two-arm randomized controlled trial 
(RCT), embedded with qualitative process evaluation (this is to be completed after the polit 
RCT and will not be included in this current grant application), investigating the effects of 
mindfulness-based eHealth CR on stress and related health outcomes of people with CHD.  
b. Subjects and Setting 
Inclusion criteria. People will be eligible for this study if they were diagnosed with 
CHD (within the past 3 months), undergone conservative treatment, such as percutaneous 
coronary intervention (PCI) and/ or medication, currently under stable medication regimen 
and discharged to home. Additional requirements are adults aged 18 years or older; 
reported scores ranging from 3 (to some degree) to 5 (very much) scores on a single-item 
stress symptoms scale (Elo et al., 2003), using a computer and/or smartphone to access the 
Internet at home; and, read and speak Chinese. Exclusion criteria are a diagnosis of acute 
psychotic disease; presence of a life-limiting condition; prescribed contradictions to 
physical activity; and, presence of hearing, visual, or ambulatory disorders.  
 
c. Instruments  
Outcome evaluation will take place in the PI’s research center at the baseline. At the 6-
week intervention point (T1), and upon completion of the 12-week intervention (T2), data 
collection will be conducted online using Qualtrics Survey Software. A link and QR code 
will be generated to be disseminated to participants by trained research assistants who are 
blinded as to the participant’s group allocation.  

Socio-demographic and clinical data will be collected at baseline. Socio-demographic data 
will be collected from the participants, including age, sex, education, marital status, 
employment, co-residency, and internet usage. Clinical data will include diagnosis, 
documented hypertension, dyslipidemia and diabetes, current blood pressure and body 
weight, treatment, and the number of medications. 
Primary outcome  
The Perceived Stress Scale (PSS-10) will be used to assess stress levels over the past month 
(Leung et al., 2010) with total scores ranging from 0 to 40 and higher scores indicating 
higher psychological stress. The Chinese version of PSS-10 has demonstrated good 
reliability with Cronbach's α coefficient of 0.83 and 0.76 for positive and negative subscale, 
respectively. It also exhibits factorial validity with adequate fit (Leung et al., 2010).  
Secondary outcomes 
The presence of psychological symptoms regarding anxiety and depression will be 
measured using the Chinese version of Generalized Anxiety Disorder 7-item and Patient 
Health Questionnaire (PHQ-9). The Chinese version of the GAD-7 scale has demonstrated 
good reliability with a Cronbach's alpha coefficient of 0.928 (Shih et al., 2022). It has also 
shown validity by exhibiting a significant correlation with the Beck Anxiety Inventory 
(Shih et al., 2022). The reliability of the is good, with a Cronbach's alpha coefficient of 
0.86. Additionally, it has good concurrent validity with the SF-36, a widely used health-
related quality of life measure (Wang et al., 2014). 
Physical activity levels will be measured using records of one-week step counts by 
accelerometer (Mi band), with good concurrent validity when compared to a WIMU 
PROTM inertial device at the scapular level (considered as a gold standard), with average 
bias less than 2.6 steps) (Pino-Ortega et al., 2021). The accelerometer records of sleep time 
(total, rapid eye movement stage, and non-rapid eye movement stage) will be used to reflect 
the quality of sleep, which displayed 78% accuracy, 89% sensitivity, and 35% specificity 
compared to the polysomnography (Concheiro-Moscoso et al., 2023). The tele-monitored 
data will be synchronized by enabling sharing to researcher functionality. To protect data 
security the data sharing function will be authorized only to the research team with prior 
written consent obtained.   
The Short-Form Six Dimensions (SF-6D) (highly correlated with SF-36 with Pearson 
correlation coefficient ranging from 0.861 to 0.954 (Wong et al., 2018) will be used to 
assess quality of life. The SF-6D focuses on six dimensions of health, capturing both 
physical and mental aspects, including physical functioning, role limitations, social 
functioning, pain, mental health, vitality.  
Adverse events. Adverse events related to study participation, if reported by participants, 
will be documented by the research assistants (RAs) during follow-up calls or outcome 
assessments. It is important to emphasize that this study is a minimal-risk, and the 
utilization of the eHealth CR intervention is not expected to cause any discomfort or 
inconvenience to the participants. Each device is for use by a single patient. The 
intervention implementation will be determined by the research team following the study 
proposal, following established clinical standards.  

e. Plan for Data Management and Analysis 
 
The data collected from outcome assessment, accelerometers, and the website 
system will be stored following General Data Protection Regulation (GDPR) guidelines. 
These data will be stored on encrypted servers within the data infrastructure of the PI’s 
University, ensuring compliance with GDPR standards. If any data are recorded on paper 
documents, they will be stored securely in locked cabinets to maintain confidentiality. 
Access to these paper documents will be restricted to personnel involved in data recording 
and interpretation. Other recorded data will be stored in a secured file on the University 
computer, which will be protected with password authentication to ensure limited access.  
 
 
SPSS version 23.0 will be used for data analysis, following an intention-to-treat 
principle. Descriptive statistics will be generated for demographic data. Normality 
assumptions for the variables will be examined using the Kolmogorov-Smirnov (KS) test. 
Independent sample t-test or Chi-square test will be conducted to examine baseline 
comparability between the two study groups. Generalized estimating equations (GEE) 
model will be employed to compare the changes in the outcomes across the different time 
points between the groups. The GEE model allows for estimation of missing data using the 
maximum likelihood estimation method. The potential confounding variables will be 
selected based on clinical judgment and statistical incomparability. As there were no 
clinically known covariates in the outcomes, baseline variables with statistical 
incomparability (p<0.2) will be adjusted to obtain a more precise estimation of the 
intervention effect. All data analyses will be conducted with a 5% significance level (two-
tailed).