An Integrative Cardiac Rehabilitation Employing Smartphone Technology (iCREST)

NCT05270993 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2022-04-06

No results posted yet for this study

Summary

Aim: To develop and field test an Integrative Cardiac Rehabilitation Employing Smartphone Technology (I-CREST) system, and evaluate its effects on CR utilization, cardiac self-efficacy, functional capacity, health-related quality of life (HRQoL), anxiety, depression, medication adherence, cardiac risk factor control and clinical outcomes among post-myocardial patients in Singapore.

Background: Centre-based cardiac rehabilitation (CBCR) participation rates among eligible patients remain low at 10-30% worldwide and less than 10% in Singapore, reportedly due to long-standing challenges surrounding accessibility, conflicting commitments, low socioeconomic status, and costs. A recent challenge is the COVID-19 pandemic, that resulted in the partial or complete closures of CBCR programmes Alternative strategies to deliver cardiac rehabilitation using novel technologies are needed to increase participation rates and improve health outcomes.

Design: A single-blinded two-arm randomised controlled trial (RCT) will be adopted.

Methodology: The is a two-phase study. Phase one involves the development and field-testing of the I-CREST system. The I-CREST system comprises of a smartphone application, a wearable heart rate monitor and a web-portal.

Phase two is a single-blinded two-arm RCT with repeated measures. 124 participants will be recruited from the National University Hospital in Singapore and will be randomly allocated to intervention or control group. Participants in the intervention group will receive the 6-week I-CREST intervention - including the newly developed I-CREST system, one face-to-face training session, and weekly telephone calls. The participants in the control group will receive the 4-week traditional CBCR.

Data will be collected at baseline, at 6 weeks (after completion of the CR programme), at 3months and at 6months from baseline. Sociodemographic and clinical data will also be collected. A cost-effectiveness analysis will also be performed to evaluate the feasibility of I-CREST compared to the CBCR platform. To assess the participants' experiences of the I-CREST system, a process evaluation will be undertaken at the conclusion of the study.

Significance. This study will generate insights into the suitability and effectiveness of I-CREST as an alternative to traditional CBCR outpatient services.

Conditions

Interventions

BEHAVIORAL

Traditional Centre-based Cardiac Rehabilitation (CBCR) group

A 4-week centre-based outpatient cardiac rehabilitation programme where patients will receive 12 group-based sessions. Patients will also be given access to online educational resources. Participants will also receive all usual nursing, medical and follow-up service provided by the hospital.

BEHAVIORAL

I-CREST group

A 6-week home-based cardiac rehabilitation programme where participants will receive an I-CREST app (to deliver education, medication reminders, exercise and vital monitoring) and a wearable smartwatch device (to track physical activity). Participants will be remotely supervised by the cardiac rehabilitation team via an I-CREST web-portal. Participants will also receive all usual nursing, medical and follow-up service provided by the hospital.

Sponsors & Collaborators

Principal Investigators

  • Wenru Wang, PhD · National University of Singapore

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-30
Primary Completion
2023-03-14
Completion
2023-12-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05270993 on ClinicalTrials.gov