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Not yet recruitingNCT06617234Updated Oct 2, 2024

A Comparative Pilot Study on the Effectiveness of Nurse-Led and LINE Robot-Guided Cardiac Rehabilitation Referrals

An interventional study of Nurse-led Intervention Program and LINEbot Automated Robot System in Cardiac Rehab, Referral and LINE Robot Intervention, sponsored by National Taiwan University Hospital. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-10-02.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Jan 2026, 8 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 99 Years
Sex
All
01

Study 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.

Read the detailed description

This comparative pilot study aims to evaluate the effectiveness of cardiac rehabilitation (CR) referral systems using two different intervention strategies: nurse-led education and LINE robot-guided interventions. The study\'s objective is to assess whether these methods can improve referral rates, attendance, and participation in CR programs compared to standard care.

Background:

Cardiovascular diseases (CVD) account for a significant proportion of global deaths and have remained the second leading cause of death in Taiwan for many years. Despite the proven benefits of CR-such as reducing mortality rates by 13%-24%, improving physical activity, enhancing cardiac function, and lowering healthcare costs-its implementation is far from ideal. International data suggest that only 20%-25% of eligible patients actually participate in CR programs.

CR is recommended for a wide range of cardiac conditions, including acute myocardial infarction (AMI), coronary artery bypass grafting (CABG), and heart failure (HF). Effective referral mechanisms are critical for ensuring that patients have access to these services. However, referral rates for CR are significantly lower than other secondary prevention measures, such as medication adherence.

Study Design and Interventions:

The study adopts an open-label, three-arm, parallel-group randomized controlled design. Participants will be randomly assigned into one of three groups:

Intervention Group A: Nurse-led education and referral program. Intervention Group B: LINE robot-guided referral system. Control Group: Standard care (usual care with CR referral as per existing practice).

Nurse-Led Education Program (Group A): Patients will receive a face-to-face education session with a trained nurse, specializing in cardiology, on the third day post-admission or after being transferred to a general ward. This session will last for 15-20 minutes and will cover the following key areas:

The importance of CR in improving cardiac function, reducing rehospitalization rates, and enhancing quality of life.

The structure of hospital-based CR programs and how they combine exercise monitoring, diet management, emotional support, and medication management.

Individualized discussions, where patients can ask questions and receive tailored advice based on their medical history and lifestyle.

LINE Robot-Guided Program (Group B): This intervention uses the LINEbot system, designed to automate patient education and reminders. The system sends daily messages to patients, including CR-related educational content, exercise instructions, and motivational prompts. Features include:

Automated educational messages: covering CR importance, exercise guidance, and diet management.

Exercise tracking: allowing patients to log their physical activities and vital signs.

Communication tools: enabling interaction between patients and the healthcare team.

Study Duration and Data Collection: The study will last 12 weeks for each participant. Data will be collected from hospital records, patient self-reports, and the automated LINE system. Outcomes measured will include:

Primary Outcomes: Referral rates, attendance at CR sessions, and program completion.

Secondary Outcomes: Patient satisfaction, perceived usefulness of the intervention, and health improvements (e.g., physical activity, heart rate variability).

Randomization and Recruitment: Participants will be recruited from cardiology wards based on inclusion criteria (patients diagnosed with AMI, HF, or post-CABG with NYHA Class I-III). Randomization will be performed using the REDCap system, with stratification by diagnosis (AMI, HF, or post-CABG).

Significance: This study will provide critical insights into the effectiveness of nurse-led and digital interventions in increasing participation in CR programs. It will explore the potential of digital tools like LINEbot in enhancing patient engagement, potentially reducing the workload of healthcare providers while promoting patient self-management and adherence.

02

Conditions studied

  • Cardiac Rehab
  • Referral
  • LINE Robot Intervention

Keywords

  • cardiac rehabilitation
  • automated system or chatbot
03

In context

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Nurse-led Intervention Program

  • Experimental
    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.

    Other: LINEbot Automated Robot System

  • No intervention
    Control Group (Usual Care)

    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

  • OtherNurse-led Intervention Program

    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.

  • OtherLINEbot Automated Robot System

    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.

06

What researchers measure

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.

    Time frame: 12 weeks post-discharge

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 23847263 ↗

Individual participant data

Plan to share: No — 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06617234
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
Sep 27, 2024
Start date
Jan 30, 2025 (estimated)
Primary completion
Jan 31, 2026 (estimated)
Completion
Jan 31, 2026 (estimated)
Last update
Oct 2, 2024

Study contacts

YU-CHEN CHUNG
Contact
j6d168@gmail.com
+886 223123456

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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