Coronary Heart Disease Clinical Trial
Official title:
Feasibility and Preliminary Evaluation and the Effects of Exercise-based Telerehabilitation on the Acceptability and Safety, and Clinical Effectiveness Among Patients With Coronary Heart Disease Undergoing the Cardiac Rehabilitation Program
Verified date | May 2024 |
Source | University of Malaya |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The intervention will involve a system that comprises a wrist-worn activity tracker and a smartphone app that acts as a medium to link to the healthcare website
Status | Completed |
Enrollment | 30 |
Est. completion date | December 31, 2023 |
Est. primary completion date | May 26, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adults with 18 years old and above with indexed diagnosis of coronary heart disease (CHD) and are referred for Cardiac Rehabilitation Program; - Low- and moderate-risk patient category (controlled BP, sinus rhythm at 60-90 bpm, pain score< 3/10) and received a statement of medical clearance by a CR physician to undertake exercise with minimal supervision; - The patient is willing to wear trackers during waking hours, own a personal smartphone and have access to internet/Wi-Fi; and - Participant must be able to able to read, speak and understand English and Malay. Exclusion Criteria: - Heart failure NYHA Stage 3-4, pulse undetected by trackers; - The participant who cannot detect their pulse through wrist-worn tracker; - Do not own a smartphone with the mobile internet/Wi-Fi ; and - Contraindicated for an exercise stress test and concomitant morbidity that limit physical activity and exercise. |
Country | Name | City | State |
---|---|---|---|
Malaysia | Rehabilitation Medicine, Pusat Perubatan Universiti Malaya | Kuala Lumpur |
Lead Sponsor | Collaborator |
---|---|
University of Malaya |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility (Recruitment procedure) | To inform the patient's acceptability towards recruitment procedure | 12 weeks | |
Primary | Feasibility (Randomization procedure) | To inform the patient's acceptability towards randomization procedure | 12 weeks | |
Primary | Feasibility (Cardiac rehabilitation program adherence) | To inform the patient's acceptability towards cardiac rehabilitation program adherence | 12 weeks | |
Primary | Feasibility (Assessment adherence) | To inform the patient's acceptability towards assessment adherence | 12 weeks | |
Primary | Feasibility (Safety - hospital readmission) | To inform the patient's safety on hospital readmission | 12 weeks | |
Primary | Feasibility (Safety - cardiac adverse events) | To inform the patient's safety on cardiac adverse events | 12 weeks | |
Primary | Exercise capacity during exercise stress test | Changes of metabolic equivalents (METs) | 12 weeks | |
Primary | Exercise capacity during six-minutes walking test | Changes of walking distance (meter) | 12 weeks | |
Secondary | Exercise adherence - Steps count | Changes in patient's weekly steps count. | 12 weeks | |
Secondary | Exercise adherence - Exercise frequency | Changes in patient's weekly exercise frequency. | 12 weeks | |
Secondary | Exercise adherence - Exercise duration | Changes in patient's weekly exercise duration (minutes). | 12 weeks | |
Secondary | Hospital readmission | Changes of frequency of hospital readmission throughout the intervention | 12 weeks | |
Secondary | Cardiac adverse events | Changes of frequency of cardiac adverse events throughout the intervention | 12 weeks | |
Secondary | Blood collection - serum cholesterol | Changes of serum cholesterol (mmol/L) | 12 weeks | |
Secondary | Blood collection - triglyceride | Changes of serum triglyceride (mmol/L) | 12 weeks | |
Secondary | Blood collection - high-density lipoproteins (HDL) | Changes of high-density lipoproteins (HDL) (mmol/L) | 12 weeks | |
Secondary | Blood collection - low-density lipoprotein (LDL) | Changes of low-density lipoprotein (LDL) (mmol/L) | 12 weeks | |
Secondary | Blood collection - Haemoglobin A1C (HA1c) | Changes of Haemoglobin A1C (HA1c) (mmols/mol) | 12 weeks | |
Secondary | Body mass (kg) | Changes of body mass (kg) | 12 weeks | |
Secondary | Body mass index (BMI) (kg/m2) | Changes of BMI (kg/m2) | 12 weeks | |
Secondary | Usability scale score | Measured by using mHealth App Usability Questionnaire (MAUQ). Indicators are evaluated according to the seven-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree" on smartphone app ease of use, interface and satisfaction, and usefulness. | 12 weeks | |
Secondary | Factors associated with non-adherence to cardiac rehabilitation program score | Measured by using Cardiac Rehabilitation Barriers Scale (CRBS) questionnaire. Indicators are evaluated according to the five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree." | 12 weeks | |
Secondary | Quality of life (QOL) score | Measured by using WHO Quality of Life-BREF (WHOQOL-BREF) questionnaire. Indicators are evaluated according to the five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree" on the physical health, psychological, social relationship and environment. | 12 weeks | |
Secondary | Fitness tracker acceptance score | Measured by using Technology Acceptance Model (TAM) questionnaire. Indicators are evaluated according to the five-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree" on the effort expectancy, performance expectancy, facilitating conditions, perceived enjoyment, perceived fee, perceived privacy, perceived trust, perceived value, social influence, perceived health increase and intention to use. | 12 weeks | |
Secondary | Participant's acceptance to the exercise-based telemonitoring | Exploring the participant's acceptance of the exercise-based telemonitoring through the interview session | 12 weeks |
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