| CTRI Number |
CTRI/2025/06/088163 [Registered on: 03/06/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [AI-powered cardiac chatbot (“Smart CABGuard”) ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Chat App Support for Safer Recovery After Heart Bypass Surgery |
|
Scientific Title of Study
|
Effectiveness of nurse led AI powered cardiac chatbot in prevention and early detection of post-operative complications among CABG patients |
| Trial Acronym |
ENACT - CABG |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SALINI K |
| Designation |
Ph.D Scholar |
| Affiliation |
Amrita Institute of Medical Sciences and Research Center |
| Address |
Amrita College of Nursing, Amrita Vishwa Vidyapeetham, Health Sciences Campus, Amrita Institute of Medical Sciences and Research Center,
Elamakkara (P.O),
Kochi.
Ernakulam
KERALA
682041
India |
| Phone |
9820894055 |
| Fax |
|
| Email |
salinik@nursing.aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
LtColDrAjee K L |
| Designation |
Professor and HOD of Fundamentals of Nursing |
| Affiliation |
Amrita Institute of Medical Sciences and Research Center |
| Address |
Amrita College of Nursing, Amrita Vishwa Vidyapeetham, Health Sciences Campus, Amrita Institute of Medical Sciences and Research Center,
Elamakkara (P.O),
Kochi.
Ernakulam
KERALA
682041
India |
| Phone |
8335053920 |
| Fax |
|
| Email |
ajeekl@nursing.aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
SALINI K |
| Designation |
Ph.D Scholar |
| Affiliation |
Amrita Institute of Medical Sciences and Research Center |
| Address |
Amrita College of Nursing, Amrita Vishwa Vidyapeetham, Health Sciences Campus, Amrita Institute of Medical Sciences and Research Center,
Elamakkara (P.O),
Kochi.
Ernakulam
KERALA
682041
India |
| Phone |
9820894055 |
| Fax |
|
| Email |
salinik@nursing.aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Sigma Small Grants, Sigma Foundation for Nursing 550 W. North Street Indianapolis,IN 46202 USA Email: research@sigmanursing.org |
|
|
Primary Sponsor
|
| Name |
Amrita Vishwa Vidyapeetham |
| Address |
Amrita College of Nursing Amrita Institute of Medical Sciences and Research Edappally.PO Kochi - 682041 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SALINI K |
Amrita Institute of Medical Sciences and Research Center – C.V.T.S Department |
Amrita Institute of Medical Sciences and Research Center Edappally P.O, Kochi
Ernakulam
KERALA |
9820894055
salinik@nursing.aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I257||Atherosclerosis of coronary arterybypass graft(s) and coronary artery of transplanted heart with angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Smart CABGuard |
Nurse-led AI-powered cardiac chatbot (“Smart CABGuard”) used as a voice/text assistant for CABG patients during the first 30 days post-discharge. Type: Nurse-led, AI-powered voicebot (chatbot) Duration: 30 days post-CABG surgery Mode of Delivery: Mobile-based voice and chat interface, accessible via smartphone or tablet Target Group: Patients discharged after Coronary Artery Bypass Grafting (CABG) surgery Daily Check-ins Automated symptom questionnaires (voice/chat) focused on: Chest pain Wound site issues Breathing difficulty Palpitations Fever or general malaise Educational Support Personalized health education content delivered in voice/text form on: Medication adherence Wound care practices Diet and exercise post-CABG Warning signs to monitor Follow-up and rehabilitation guidance Symptom Alert System AI algorithms flag responses indicating possible complications Triggers alerts to assigned nurse or physician for timely action Emergency escalation protocols if critical symptoms are detected Reminders & Notifications Daily reminders for: Medication intake Follow-up appointments Exercise/rehabilitation routines Patient Feedback & Interaction Logs Captures patient satisfaction and usage data Monitors engagement levels and usability Adjusts messaging tone and frequency based on patient interaction Language & Accessibility Available in English and local languages (e.g., Malayalam) Designed for low digital literacy; uses voice guidance |
| Comparator Agent |
Standardized discharge advice |
1. Medication Adherence Take all prescribed medications on time (e.g., antiplatelets, statins, beta-blockers). Understand the purpose, dosage, and potential side effects. Do not stop any medication without consulting your cardiologist. 2. Wound Care Instructions Keep the surgical incision clean and dry. Report signs of infection such as redness, swelling, discharge, or fever. Follow dressing change instructions as advised. 3. Physical Activity Gradual resumption of daily activities within 1–2 weeks. Avoid lifting heavy weights (5 kg) for 6 weeks. Follow any exercise regimen prescribed during cardiac rehabilitation. 4. Dietary Guidelines Follow a low-fat, low-salt, heart-healthy diet. Limit sugar and processed foods. Increase intake of fruits, vegetables, and whole grains. 5. Lifestyle Modifications Stop smoking and avoid alcohol. Manage stress through relaxation techniques, meditation, or counseling. 6. Symptom Monitoring Watch for symptoms like chest pain, shortness of breath, palpitations, dizziness, or swelling. Maintain a symptom diary if advised. 7. Follow-Up Attend all scheduled follow-up visits with your cardiologist or surgeon. Carry your discharge summary and medical reports to each visit. 8. Emergency Warning Signs Seek immediate medical attention if any of the following occur: Chest pain that does not go away Sudden shortness of breath High-grade fever (101°F) Fainting or blackouts Profuse wound discharge 9. Contact Information Provide 24/7 hospital or cardiac emergency helpline number. Share outpatient clinic contact details for appointment booking. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Phase 1- Retrospective Cohort
1. Medical records of patients who underwent Coronary Artery Bypass Graft (CABG) surgery in 2020–2024 and were readmitted within 30 days following the procedure because of post-operative complications
2. Medical records of patients above 18yrs (Adults)
Phase 2 & Phase 3
1. Patients undergoing Coronary Artery Bypass Graft (CABG) surgery willbe eligible for the study.
2. Patients above 18yrs (Adults)
|
|
| ExclusionCriteria |
| Details |
Phase 1- Retrospective Cohort
1. Medical records of patients who underwent CABG surgery combined with other procedures (eg: Cardiac valverepair, Aortic aneurism repair) in 2020–2024
2. Medical records of patients who underwent CABG surgery done in “ON PUMP” method in 2020–2024
3. Patient medical records having 50% or more missing information from patients who had Coronary Artery Bypass Graft (CABG) surgery between 2020 and 2024
Phase 2 & Phase 3
1. Patients undergoing elective Coronary Artery Bypass Graft (CABG) surgery
2. CABG done in “ON PUMP” method
3. Patients below 18 yrs (Adults)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduced Complication Rate: A decrease in the occurrence of complications among patients using the chatbot.
Reduced Readmission Rate: Fewer hospital readmissions in the intervention group within 30 days post-CABG.
Improved Patient Outcomes: Measured through lower Cardiac Post-Operative Morbidity Scores (C-POMS), showing the chatbot’s impact on health improvements.
|
Reduced Complication Rate: A decrease in the occurrence of complications among patients using the chatbot.
Reduced Readmission Rate: Fewer hospital readmissions in the intervention group within 30 days post-CABG.
Improved Patient Outcomes: Measured through lower Cardiac Post-Operative Morbidity Scores (C-POMS), showing the chatbot’s impact on health improvements.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Completion of Chatbot Development: A functional AI- powered cardiac chatbot designed to meet CABG patient needs for postoperative care.
Validated Chatbot Usability and Acceptability:
Patient Satisfaction on chatbot effectiveness in delivering postoperative care support.
|
Completion of Chatbot Development: 2-3 months
Validated Chatbot Usability and Acceptability: 2 months
Patient Satisfaction Ratings: 12 months
|
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - Results obtained from analyzed data will be shared
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shalini.vinesh2012@gmail.com].
- For how long will this data be available start date provided 31-07-2026 and end date provided 31-07-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Coronary artery bypass graft (CABG) surgery often leads to significant postoperative complications in ~15–30% of patients, and about 13% of CABG patients are readmitted within 30 days. Nurse-led interventions and novel technologies may improve early detection and management of these complications. In this study, we will evaluate a nurse-led AI-based “Smart CABGuard” chatbot designed for remote monitoring of CABG patients after discharge. In a randomized controlled trial at AIMS Kochi, adult CABG patients will be assigned to receive either standard postoperative care or additional support via the chatbot for 30 days. The primary endpoint is the 30-day postoperative complication rate (assessed by C-POMS). Secondary endpoints include 30-day readmission rate, time to any intervention prompted by the chatbot, patient morbidity scores at 30 days, and user satisfaction with the chatbot. AI-powered chatbots have been shown to enhance health care quality and efficiency this trial will test whether the nurse-led chatbot can safely reduce complications and readmissions in post-CABG care. |