Clinical trial NCT06617234: A Comparative Pilot Study on the Effectiveness of Nurse-Led and LINE Robot-Guided Cardiac Rehabilitation Referrals
Official title: A Comparative Pilot Study on the Effectiveness of Cardiac Rehabilitation Referral Guided by Nurse-Led and LINE Robot Interventions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Rehab
Referral
LINE Robot Intervention
Keywords: cardiac rehabilitation
automated system or chatbot
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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\&#39;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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Cardiac Rehabilitation Participation Rate
timeFrame: 12 weeks post-discharge
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.