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CTRI Number  CTRI/2021/09/036388 [Registered on: 09/09/2021] Trial Registered Prospectively
Last Modified On: 06/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Home-based cardiac rehabilitation program on compliance and selected health outcomes among cardiac patients. 
Scientific Title of Study   A Randomized Controlled Trial to assess effectiveness of Home-based cardiac rehabilitation program on compliance and selected health outcomes among cardiac patients in selected hospitals of Punjab. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sawroop Dhillon 
Designation  Research Scholar 
Affiliation  UGC and Govt. of India 
Address  Chitkara School of Health Sciences, Department of Nursing, Galileo block, Room no-1 Chitkara University, Punjab-140401
Vill-Nainowal Vaid, P.O-Sikri, Distt-Hoshiarpur, Punjab-146113
Hoshiarpur
PUNJAB
140401
India 
Phone  9915154302  
Fax    
Email  sawroop.dhillon@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harmeet Kaur 
Designation  Principal cum Professor 
Affiliation  UCG and Govt of India 
Address  Chitkara School of Health Sciences, Department of Nursing, Galileo block, Room no-1 Chitkara University, Punjab-140401
Dr. Harmeet Kaur W/o Dr. Tejinderpal Singh, H.No.T-I, 55, Sector 25. Panjab University Campus Chandigarh
Rupnagar
PUNJAB
140401
India 
Phone  9815143237  
Fax    
Email  harmeet.kaur@chitkara.edu.in  
 
Details of Contact Person
Public Query  
Name  Sawroop Dhillon 
Designation  Research Scholar 
Affiliation  UGC and Govt. of India 
Address  Chitkara School of Health Sciences, Department of Nursing, Galileo block, Room no-1 Chitkara University, Punjab-140401
Vill-Nainowal Vaid, P.O-Sikri, Distt-Hoshiarpur, Punjab-146113
Hoshiarpur
PUNJAB
140401
India 
Phone  9915154302  
Fax    
Email  sawroop.dhillon@gmail.com  
 
Source of Monetary or Material Support  
Sawroop dhillon D/O Gurdev Singh Vill-Nainowal Vaid, P.O-Sikri, Distt-Hoshiarpur, Punjab-146113 
 
Primary Sponsor  
Name  Sawroop Dhillon 
Address  Vill-Nainowal Vaid, P.O-Sikri, Distt-Hoshiarpur, Punjab-146113 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raman Chawla  CareMax superspeciality hospital Jalandhar  333, Guru Nanak MIssion Chowk, Near Guru Nanak MIssion Chowk, Lajpat Nagar, Jalandhar, Punjab - 144001
Jalandhar
PUNJAB 		 9814060217
9194182116
info@caremaxhospital.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION ETHICS COMMITTEE CHITKARA UNIVERSITY, Punjab  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I20||Angina pectoris, (2) ICD-10 Condition: I501||Left ventricular failure, unspecified, (3) ICD-10 Condition: I21A||Other type of myocardial infarction, (4) ICD-10 Condition: I502||Systolic (congestive) heart failure, (5) ICD-10 Condition: I504||Combined systolic (congestive) anddiastolic (congestive) heart failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  cardiac patients undergone treatment at the selected hospitals of Jalandhar, Punjab.  The subjects in control group will be getting usual care i.e follow up visits to cardiologist, including routine education and medication prescription 
Intervention  Home-based cardiac rehabilitation program   Intervention that is Home-based cardiac rehabilitation program Components includes Session on Importance of Cardiac rehabilitation will be carried out in selected hospitals during enrollment of patients,Physical Activity with the help of Video & Exercise Booklet,Dietary counselling including education and weekly menu for dietary changes, Medication adherence counselling and Stress management activities  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Those had undergone:
1.Cardiac events- myocardial infarction, coronary artery disease, stable angina, heart failure.
2.Interventions-Coronary Artery Bypass Grafting, Percutaneous Coronary Interventions, Valve Replacement, Pacemaker, Implanted Cardioverter Defibrillator.
3.Are in class-I and II according to New York Heart Association Functional Classification of Heart Failure.
 
 
ExclusionCriteria 
Details  1.Those had Unstable angina pectoris,Acute endomyocarditis or other acute infections, Recent pulmonary artery embolism or phlebothrombosis, hemodynamically relevant arrhythmia, Critical obstructions of the left ventricular discharge apparatus
2. Those who have Physical, psychological or mental limitations prohibiting cardiac rehabilitation
3. Those who are in class-III and IV according to New York Heart Association Functional Classification of Heart Failure.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Proportion of patients with improved physical activity i.e. at least 30 minutes of moderate physical activity 5 days a week or more (minimum 150 minutes /week)
2. Proportion of patients with improved Diet i.e Saturated fats: 10% of total dietary energy per day, Fruits and vegetable: at least five portions of fruits and vegetable in a day or 400gms per day, Salt intake: less than 6gms of salt per day.
3. Medication Adherence
 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.6-Minute walk distance
2.BMI ( 25kg/m2)
3.Blood Pressure (140/90 mmHg)
4.Lipid Profile: Total Cholesterol (5·0 mmol/L), Triglycerides (150mg/dL), LDL (Low Density Lipids) (129mg/dL), HDL (High Density Lipids) (60mg/dL).
5.HRQOL (Health related quality of life)
6.Depression
7.Anxiety
Long term outcomes: will be assessed after 6 months in terms of-
1.Re-hospitalization
2.Survival
 		 3 months 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "97"
Final Enrollment numbers achieved (India)="97" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/09/2021 
Date of Study Completion (India) 22/12/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sawroop.dhillon@gmail.com].

  6. For how long will this data be available start date provided 21-02-2022 and end date provided 21-02-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Introduction: Coronary artery disease (CAD) is a disease process that includes partial to complete occlusion of the vessel. Despite developments in treatment modalities, there is 9-fold increase in the incidence of CAD in the last twenty years in India. Cardiac rehabilitation as secondary prevention to cardiac events helps to reduce rehospitalization and assist patients with CAD to return to an active and satisfying life. Studies, unfortunately, revealed a higher attrition rate and underused CR services and a 10–30% lower rate among rural populations due to geographical location or health professional availability. It is hypothesized that Nurse-led-cardiac rehabilitation program is effective in improving health outcomes of cardiac patients as compared to conventional cardiac rehabilitation program.

Methodology: A randomized control trial is designed to evaluate the effectiveness of Nurse-led-cardiac rehabilitation program on selected health outcomes among cardiac patients after randomizing them to experimental and control group. All patients will start an exercise training in a supervised setting and then transition to a home-based regimen by giving them information booklets and CDs regarding exercises. The outcomes will be measured on the 3rd, 6th and 8th week of the program in terms of risk factors assessment parameters (Vital Parameters, BMI, Blood Chemistry, Lipids level, RFTs, LFTs), NYHA classification for assessment of Functional Status, 6 min walk test for evaluation of Exercise capacity, Quality of Life SF-36, Beck Anxiety inventory, Beck Depression Inventory.

Results: After reviewing literature, it was found that Nurse-led heart failure clinics are being practiced for years’ internationally but are not yet started in Punjab. Surely, there is a need to promote this hospital-home connection services led via cardiac nurse in preventing and managing CAD crisis.

Conclusion/Implication: The patients who were provided with comprehensive CR program by cardiac nurses improved significantly in many terms. So, it was highly recommended in these studies to implement CR program led by a trained cardiac nurse for secondary prevention in patients with CHD.

Key Words: Nurse-led-cardiac rehabilitation program, health outcomes, cardiac patients. 

 
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