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CTRI Number  CTRI/2024/09/073850 [Registered on: 12/09/2024] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To find out how the individual counseling and teaching methods about their disease management will improve their life quality and their health status  
Scientific Title of Study   Effectiveness of self management program on hospital readmission and emergency department visits of patients with acute exacerbation of chronic obstructive pulmonary disease - A Randomised Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Lakshmi Ramamoorthy 
Designation  Assistant Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical education and Research  
Address  Department of Nursing, JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9843299340  
Fax    
Email  laxmi_ramamoorthy@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Krishna Priya C V 
Designation  M.sc Medical Surgical Nursing student  
Affiliation  Jawaharlal Institute of Postgraduate Medical education and Research  
Address  Department of Medical Surgical Nursing, college of Nursing,Jawaharlal Institute of Postgraduate Medical Education and Research

Pondicherry
PONDICHERRY
605006
India 
Phone  8838861525  
Fax    
Email  cvkrishnapriya575@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Lakshmi Ramamoorthy 
Designation  Assistant professor  
Affiliation  Jawaharlal Institute of Postgraduate Medical education and Research  
Address  Department of Nursing, JIPMER, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9843299340  
Fax    
Email  laxmi_ramamoorthy@yahoo.com  
 
Source of Monetary or Material Support  
Intramural Fund, Jawaharlal Institute of Postgraduate Medical Education and Research 605006 India 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical education and Research  
Address  Jipmer Campus Rd, Jipmer Campus, Puducherry, 605006 
Type of Sponsor  Research institution and hospital 
 
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 Lakshmi Ramamoorthy  Jawaharlal Institute of Postgraduate Medical education and Research   Pulmonary medicine ward, First floor,old building, Pulmonary Medicine department.
Pondicherry
PONDICHERRY 		 09843299340

laxmi_ramamoorthy@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAl STUDIES, JIPMER   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Regular discharge advice   Regular advice followed in hospital such as medication details, follow up details for 25 minutes  
Intervention  Self management program   This program includes Teaching about their disease conditions and their management, Inhaler technique, breathing exercises and life style modification for 30-45 Minutes and weekly follow-up through mobile and 3 month once OPD follow-up which may take 10-15 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients with the age of 18 years and above.
Patients hospitalized at JIPMER with acute exacerbation of COPD.
Patients who will be attending their follow-up at pulmonary OPD JIPMER, after discharge. 
 
ExclusionCriteria 
Details  Patient with sensory or cognitive impairment.
Patients with coexisting lung conditions like lung cancer, pulmonary TB, interstitial lung disease, and congestive left cardiac failure.
Patients with myocardial infarction or unstable angina within the previous month.
Hemodynamically unstable patients requiring mechanical ventilation or vasopressors. 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of self-management program on hospital readmission and emergency department visits due to COPD within 6 months among patients with acute exacerbation of COPD.  6 Months  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the level of adherence to inhaler between the intervention and the control group.
To compare the exercise tolerance between the intervention and control group. 		 6 Month 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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   N/A 
Date of First Enrollment (India)   23/09/2024 
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="0"
Months="6"
Days="10" 
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 - NO
Brief Summary
Modification(s)  		 This study is a randomized, parallel, single-centered design. This study involves individual counseling sessions for patients with acute exacerbation of chronic obstructive pulmonary disease admitted at the tertiary care center. At the time of discharge from the hospital, patients will be demonstrated and counseled on self-management strategies focusing on inhaler adherence, breathing exercises, and controlling risk factors, followed by telephone follow-up once every week, and clinical follow-up once a month during their routine hospital OPD visit will be done. At the end of 6 months, we will assess inhaler adherence, health-related quality of life, hospital readmission rate, and number of emergency department visits. 
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