NCT07109752

Brief Summary

People with coronary heart disease (CHD) often feel more stressed, which can increase the risk of having another heart problem. Cardiac rehabilitation (CR) is a common treatment for those with CHD, focusing on changing lifestyles and managing the disease. However, it often does not address stress management adequately. There is also a lack of psychological therapy and involvement of mental health professionals in online CR programs. Because traditional CR programs have low participation rates, online platforms are becoming more popular for providing rehabilitation support. This is important because more than half of people with CHD report high stress levels, which can cause or worsen heart problems. To address this issue, the proposed study will test an online CR program that includes mindfulness to help manage stress for CHD patients.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

July 20, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2026

Completed
Last Updated

August 7, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

July 18, 2025

Last Update Submit

July 30, 2025

Conditions

Keywords

cardiac rehabilitationmindfulnesseHealth

Outcome Measures

Primary Outcomes (1)

  • Perceived stress level

    The Perceived Stress Scale (PSS-10), with total scores ranging from 0 to 40 and higher scores indicating higher psychological stress

    baseline, 6-week, 12- week

Secondary Outcomes (5)

  • Anxiety level

    baseline, 6-week, 12-week

  • Depression level

    baseline, 6-week, 12-week

  • Physical activity

    baseline, 6-week, 12-week

  • Sleep

    baseline, 6-week, 12-week

  • Health Related Quality of life

    baseline, 6-week, 12-week

Study Arms (2)

eCR

EXPERIMENTAL

Intervention arm

Behavioral: eHealth cardiac rehabilitation

Control

NO INTERVENTION

Usual care

Interventions

A face-to-face interview for goal setting and action planning, as well as learning the use of CR website and accelerometer.

eCR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People will be eligible for this study if they were:
  • diagnosed with CHD (within the past 6 months),
  • undergone conservative treatment, such as percutaneous coronary intervention (PCI) and/ or medication,
  • currently under stable medication regimen and discharged to home.
  • 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.

You may not qualify if:

  • diagnosis of acute psychotic disease;
  • presence of a life-limiting condition;
  • prescribed contradictions to physical activity; and,
  • presence of hearing, visual, or ambulatory disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tung Wah College

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Batalik L, Filakova K, Sladeckova M, Dosbaba F, Su J, Pepera G. The cost-effectiveness of exercise-based cardiac telerehabilitation intervention: a systematic review. Eur J Phys Rehabil Med. 2023 Apr;59(2):248-258. doi: 10.23736/S1973-9087.23.07773-0. Epub 2023 Jan 24.

    PMID: 36692413BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Jingjing Su, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 18, 2025

First Posted

August 7, 2025

Study Start

July 20, 2024

Primary Completion

January 30, 2026

Study Completion

January 30, 2026

Last Updated

August 7, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Participants may not have given explicit consent for their data to be shared beyond the initial study, limiting the ability to share their data legally and ethically.

Locations