Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617234
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
A Comparative Pilot Study on the Effectiveness of Nurse-Led and LINE Robot-Guided Cardiac Rehabilitation Referrals
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Comparative Pilot Study on the Effectiveness of Cardiac Rehabilitation Referral Guided by Nurse-Led and LINE Robot Interventions
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hospitals 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
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 hospitals 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 study39s 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None