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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04330560
Other study ID # 2018112-6846
Secondary ID RF009C-2018
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 31, 2023

Study information

Verified date May 2024
Source University of Malaya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

Feasibility study objective: - To investigate the feasibility and preliminary of exercise-based telerehabilitation before undertaking full-scale RCT. Randomized control trial objective: - 1. Primary Objective: To determine the exercise capacity among patients with CHD, 2. Secondary Objectives: To assess patient exercise adherence and determine the changes in other clinical health outcomes. Study Population: Patients with coronary heart disease Description of Sites/Facilities Enrolling Participants: Patient engagement with the cardiac rehabilitation phase 2 (CRP2) at the University Malaya Medical Centre (UMMC). Description of Study Intervention: This study is a mixed-methods study consisting of a quantitative study (feasibility, preliminary evaluation, and full randomized control trial) and a qualitative study (interviewing). The present study will be conducting a single-blinded, three-arm, parallel over a 12-weeks study period during CRP2. Measurement will be collected during pre-and post-test.


Recruitment information / eligibility

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.

Study Design


Intervention

Device:
Exercise telemonitoring connects to healthcare platform
The participant is required to wear the fitness tracker every day during waking hours throughout the 12 weeks of intervention (except during sleeping, bathing, and swimming) link to the healthcare practitioner
Exercise self-monitoring
The participant is required to wear the fitness tracker every day during waking hours throughout the 12 weeks of intervention (except during sleeping, bathing, and swimming) for exercise self-monitoring.
Exercise teleconsultation
Conducted through smartphone video call app.
Procedure:
Other CR components
Including dietary, psychology, education conducted at the center.
Standard care
Undergoing standard care by cardiac rehabilitation at the center

Locations

Country Name City State
Malaysia Rehabilitation Medicine, Pusat Perubatan Universiti Malaya Kuala Lumpur

Sponsors (1)

Lead Sponsor Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

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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