NCT04858503

Brief Summary

This study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how i-CARE influences patients' health behaviours.

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
268

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 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

April 21, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

April 21, 2021

Last Update Submit

November 30, 2023

Conditions

Coronary Artery Disease

Keywords

Self-careModel of careMobile appEmpowermentNurse-ledDisease ManagementRisk factor control

Outcome Measures

Primary Outcomes (1)

  • Self-care behaviour

    the Chinese version of Self-Care of Coronary Heart Disease Inventory (SC-CHDI). This self-reported SC-CHDI (22 items) measures self-care maintenance, self-care management and self-care confidence on a four-point response scale. Each subscale score is transformed to 100 points, with higher scores indicate better self-care for that attribute.

    Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)

Secondary Outcomes (6)

  • Biomarkers: lipid profile

    Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)

  • Physiological: blood pressure

    Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)

  • Anthropometric: waist-to-height ratio

    Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)

  • Clinical: Cardiovascular event rates and mortality

    Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)

  • Self-reported health outcomes: functional status

    Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)

  • +1 more secondary outcomes

Study Arms (2)

internet-based cardiac rehabilitation enhancement intervention

EXPERIMENTAL

internet-based cardiac rehabilitation enhancement intervention

Other: internet-based cardiac rehabilitation enhancement intervention

conventional cares as arranged by hospital or community centers

NO INTERVENTION

Participants will receive conventional cares as arranged by hospital or community centers

Interventions

internet-based cardiac rehabilitation enhancement interventionOTHER

Participants in the intervention group will receive a 12-week i-CARE intervention, which will be designed to cover the core elements of CAD self-care: self-care maintenance, self-care monitoring and self-care management. The intervention will comprise: 1) a single individualized face-to-face session and 2) an internet-based intervention through a mobile application. Various behaviour change techniques will be used to increase the self-efficacy of CAD patients in enacting self-care behaviours.

internet-based cardiac rehabilitation enhancement intervention

Eligibility Criteria

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

You may qualify if:

  • ≥18 years of age
  • living in the community,
  • own a smartphone with internet access,
  • communicable in Cantonese,
  • type in Chinese or English,
  • with a confirmed diagnosis of CAD.

You may not qualify if:

  • enrolled to a structured centre-based or home-based cardiac rehabilitation program, (2) psychiatric problems,
  • impaired cognitive functioning (i.e. Abbreviated Mental Test ≤6), and
  • terminal disease with life expectancy \< 1 year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The School of Nursing

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseEmpowerment

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesSocial BehaviorBehavior

Study Officials

  • Polly Li, Dr

    The University of Hong Kong, School of Nursing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Polly Li, Dr

CONTACT

852-39176686pwcli@hku.hk

Study Design

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

Study Record Dates

First Submitted

April 21, 2021

First Posted

April 26, 2021

Study Start

April 1, 2022

Primary Completion

June 30, 2024

Study Completion

August 31, 2024

Last Updated

December 4, 2023

Record last verified: 2023-11

Locations

HK(1)