NCT06617234

Brief Summary

The goal of this pragmatic randomized trial is to compare the effectiveness of nurse-led versus LINE bot-guided strategies on patient referrals for cardiac rehabilitation in patients with acute myocardial infarction, heart failure, or status post coronary artery bypass surgery, aged 18 years and older. The main questions it aims to answer are: Does a nurse-led referral strategy increase cardiac rehabilitation referrals, attendance, and participation compared to routine care? Can a LINE bot-guided system improve cardiac rehabilitation referrals, attendance, and participation? Researchers will compare Intervention Group A (nurse-led face-to-face education), Intervention Group B (LINE bot automated referral system), and a Control Group (routine care) to see if nurse-led or LINE bot strategies are more effective in increasing referrals, attendance, and participation in cardiac rehabilitation programs. Participants will: Be randomly assigned to one of three groups. Participate in either nurse-led education, receive automated LINE bot reminders, or undergo standard care. Have their cardiac rehabilitation referrals, attendance, and participation tracked for 12 weeks post-discharge through the hospital's medical record system. This study seeks to provide healthcare professionals with evidence-based strategies for improving cardiac rehabilitation processes and enhancing patient engagement in rehabilitation programs.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

1 year

First QC Date

September 25, 2024

Last Update Submit

September 30, 2024

Conditions

Keywords

cardiac rehabilitationautomated system or chatbot

Outcome Measures

Primary Outcomes (1)

  • Cardiac Rehabilitation Participation Rate

    The percentage of patients who are referred to and actively engage in cardiac rehabilitation programs after discharge. Active participation is defined as attending at least one session of a cardiac rehabilitation program within the 12-week period following discharge from the hospital.

    12 weeks post-discharge

Study Arms (3)

Nurse-led Intervention Program

EXPERIMENTAL

This intervention consists of a face-to-face educational session led by a nurse, focusing on the importance of cardiac rehabilitation. The session lasts 15-20 minutes and is tailored to the patient's medical condition and lifestyle, with follow-up reminders and personalized guidance for rehabilitation participation.

Other: Nurse-led Intervention Program

LINEbot Automated Robot System

EXPERIMENTAL

This intervention uses the LINEbot system to send automated push notifications to participants, including educational messages, reminders for cardiac rehabilitation appointments, and health tracking prompts. Participants can log their daily health data through the system, which offers personalized advice on diet, exercise, and medication management.

Other: LINEbot Automated Robot System

Control Group (Usual Care)

NO INTERVENTION

Participants in this group will receive usual care. This includes clinical evaluations by cardiologists and standard rehabilitation referrals without any specialized education or reminders. Their participation in cardiac rehabilitation will not be monitored or actively encouraged beyond routine clinical care. The patients decide independently whether or not to attend cardiac rehabilitation sessions.

Interventions

Nurse-led Intervention Program: This intervention consists of a face-to-face educational session led by a nurse, focusing on the importance of cardiac rehabilitation. The session lasts 15-20 minutes and is tailored to the patient's medical condition and lifestyle, with follow-up reminders and personalized guidance for rehabilitation participation. LINEbot Automated Robot System: This intervention uses the LINEbot system to send automated push notifications to participants, including educational messages, reminders for cardiac rehabilitation appointments, and health tracking prompts. Participants can log their daily health data through the system, which offers personalized advice on diet, exercise, and medication management.

Nurse-led Intervention Program

Participants in this group will use the \"LINEbot\" automated robot system, which sends push notifications through the LINE app. The system delivers education messages, exercise guidance, and health tracking prompts. It provides daily reminders for cardiac rehabilitation participation, as well as customized messages on health management, such as diet, medication, and self-care. The system also allows users to log health data like blood pressure and heart rate.

LINEbot Automated Robot System

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult ≧18 years old
  • AMI(STEMI or NSTEMI after PCI)
  • Heart failure with New York Heart Association (NYHA) functional class I-III .
  • After coronary artery bypass surgery (CABG)
  • Patients must have a smartphone with internet
  • Able to use the LINE messaging (send and receive messages)

You may not qualify if:

  • Cardiac rehabilitation absolute or relative contraindications.
  • Acute decompensated heart failure, New York Heart Association (NYHA) functional class IV
  • Cognitive impaired
  • Without smartphones
  • Attending physician finds it unsuitable.
  • One patient was enrolled in the same ward

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Clark AM, King-Shier KM, Duncan A, Spaling M, Stone JA, Jaglal S, Angus J. Factors influencing referral to cardiac rehabilitation and secondary prevention programs: a systematic review. Eur J Prev Cardiol. 2013 Aug;20(4):692-700. doi: 10.1177/2047487312447846.

Central Study Contacts

YU-CHEN CHUNG

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2024

First Posted

September 27, 2024

Study Start

January 30, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

October 2, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

At this time, there is no plan to share individual participant data (IPD) due to concerns about maintaining participant privacy and confidentiality. The study involves sensitive health information, and ensuring the protection of participant identity is a priority.