NCT05270993

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

March 30, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

12 months

First QC Date

January 30, 2022

Last Update Submit

April 4, 2022

Conditions

Myocardial Infarction

Keywords

cardiac rehabilitationhome-basedmHealthTelerehabilitationself-management

Outcome Measures

Primary Outcomes (1)

  • Cardiac Rehabilitation (CR) Utilisation

    As measured by CR uptake (defined as attending baseline assessment, and at least one exercise session for CBCR, or the uploading of at least one set of exercise data to the web-portal for i-CREST group), CR adherence (defined as attending 8 of 12 exercise sessions for CBCR or uploading of 4 weeks' exercise data for I-CREST group) and CR completion (defined as attending all 12 exercise sessions for CBCR and uploading of the whole 6-week's exercised data for I-CREST group).

    Data will be collected at 6 weeks

Secondary Outcomes (13)

  • Cardiac Self-Efficacy

    Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline

  • Health-related Quality of Life (HRQoL) - generic

    Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline

  • Health-related Quality of Life (HRQoL) - specific

    Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline

  • Anxiety and depression levels

    Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline

  • Self-regulatory behaviour

    Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline

  • +8 more secondary outcomes

Other Outcomes (2)

  • Semi-structured Interview-Process Evaluation

    6 months from baseline after participants complete the study

  • Cost and Expenditure Data

    Cost surveys will be conducted at 6 weeks, at 3 months and 6 months of the programme for both groups

Study Arms (2)

Traditional Centre-based Cardiac Rehabilitation (CBCR) group

ACTIVE COMPARATOR

A 4-week centre-based outpatient cardiac rehabilitation programme. Participants will also receive all usual nursing, medical and follow-up service provided by the hospital.

Behavioral: Traditional Centre-based Cardiac Rehabilitation (CBCR) group

I-CREST group

EXPERIMENTAL

A 6-week home-based remote supervision cardiac rehabilitation programme with an I-CREST application and smartwatch. Participants will also receive all usual nursing, medical and follow-up service provided by the hospital.

Behavioral: I-CREST group

Interventions

Traditional Centre-based Cardiac Rehabilitation (CBCR) groupBEHAVIORAL

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.

Traditional Centre-based Cardiac Rehabilitation (CBCR) group
I-CREST groupBEHAVIORAL

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.

I-CREST group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a confirmed medical diagnosis of acute MI
  • are planning to be discharged to home
  • do not intend to join any other CR programmes offered by other institutions
  • at least 21 years old
  • use smart mobile phone in their daily lives frequently and who have the basic knowledge on app use; and
  • Able to speak and understand English or Chinese.

You may not qualify if:

  • Have suffered severe complications such as uncontrolled arrhythmias, heart failure with ejection fraction (EF) \< 40%;
  • Are scheduled for coronary artery bypass grafting (CABG);
  • Have undergone cancer treatment, and other illnesses that will limit participation;
  • Have readmission plans for further revascularisation;
  • Have implanted devices;
  • Have a known history of major psychiatric illness;
  • Have pre-existing mobility problems; and
  • Have major reading and/or hearing difficulties.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, Singapore

RECRUITING

Related Publications (1)

  • Ramachandran HJ, Yeo TJ, Seah CWA, Yeo TM, Chua MCH, Syed Gani Q, Lim PS, Lai SM, Teo JYC, Wang W. Feasibility and effectiveness of an integrative cardiac rehabilitation employing smartphone technology (I-CREST): a pilot randomized controlled trial. Eur J Cardiovasc Nurs. 2025 Sep 5;24(6):959-970. doi: 10.1093/eurjcn/zvaf053.

    PMID: 40241396DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Officials

  • Wenru Wang, PhD

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenru Wang, PhD

CONTACT

(65) 66011761nurww@nus.edu.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 30, 2022

First Posted

March 8, 2022

Study Start

March 30, 2022

Primary Completion

March 14, 2023

Study Completion

December 31, 2023

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)