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CTRI Number  CTRI/2025/12/098283 [Registered on: 02/12/2025] Trial Registered Prospectively
Last Modified On: 26/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Impact of a Self-Management Intervention on Quality of Life of adults with chronic lung disease attending primary health centres in Ballabgarh, Haryana 
Scientific Title of Study   Effectiveness of a Structured Self-Management Intervention on Health-Related Quality of Life in Patients with Chronic Obstructive Pulmonary Disease (COPD) delivered in Primary Care Settings at Ballabgarh, Haryana: A quasi-experimental pragmatic 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 Palak Choudhary 
Designation  Junior Resident (MD Student) 
Affiliation  AIIMS New Delhi 
Address  Room no. 14, Centre for Community Medicine, Old OT Block, AIIMS New Delhi

South
DELHI
110029
India 
Phone  09024846815  
Fax    
Email  drpalak999@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Harshal Ramesh Salve 
Designation  Additional Professor 
Affiliation  AIIMS New Delhi 
Address  Room no. 40, Centre for Community Medicine, Old OT Block, AIIMS New Delhi

South
DELHI
110029
India 
Phone  9911253846  
Fax    
Email  harshalsalve@ymail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Harshal Ramesh Salve 
Designation  Additional Professor 
Affiliation  AIIMS New Delhi 
Address  Room no. 40, Centre for Community Medicine, Old OT Block, AIIMS New Delhi

South
DELHI
110029
India 
Phone  9911253846  
Fax    
Email  harshalsalve@ymail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences New Delhi 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Palak Choudhary  PHC Chhainsa   Room 03 Ground Floor PHC Chhainsa Ballabgarh Faridabad Pin code 121004 Faridabad HARYANA
Faridabad
HARYANA 
09024846815

drpalak999@gmail.com 
Dr Palak Choudhary  PHC Dayalpur  Room 04 Ground floor PHC Dayalpur Ballabgarh Faridabad Pin code 121004
Faridabad
HARYANA 
09024846815

drpalak999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee All India Institute of Medical Sciences Room No. 102 1st Floor Old OT Block Ansari Nagar New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COPD Treatment as per current PHC practices   Treatment as per current PHC practices  
Intervention  Structured Self Management   Face to Face sessions of around 40 minutes on Recognition of COPD exacerbation, Compliance to medication, Appropriate inhaler use technique, Lifestyle modification, Stress coping practices, Reduce air pollution exposure, Counsel for vaccination and health diary, flyer and monthly home visit by health worker for reinforcement over next 9 months. All the participants would be recruited over 10 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult COPD patients confirmed by spirometry as per
GOLD 2025 (post-bronchodilator FEV1/FVC less than 0.70)
 
 
ExclusionCriteria 
Details  Contraindications for spirometry (eg.
decompensated heart failure, active TB, malignancy, haemoptysis of unknown origin, pneumothorax, recent MI or pulmonary embolus, recent eye surgery, recent thoracic or abdominal surgery) as reported by the patients,
Critically ill patients,
Patients who do not have functional phone in the household
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Health-related Quality of Life measured using St George Respiratory Questionnaire   Baseline and endline (9 months)  
 
Secondary Outcome  
Outcome  TimePoints 
FEV1 % predicted via spirometry   Baseline and endline (9 months) 
Healthcare utilization   At 3,6 & 9 months  
Frequency of acute exacerbations of COPD  At 3,6 & 9 months  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   10/12/2025 
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="0"
Months="9"
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 - NO
Brief Summary  

This is a quasi-experimental pragmatic trial to be conducted at two Primary Health Centres (Chhainsa and Dayalpur) in the Ballabgarh field practice area of AIIMS, New Delhi. The study will include 80 adult patients with spirometry-confirmed COPD, with 40 participants enrolled at each PHC. One PHC will serve as the intervention site, where a structured self-management package will be delivered in addition to routine care, while the other PHC will serve as the control site, where patients will continue to receive treatment as per current practices. The structured intervention will be delivered through face-to-face counselling sessions at baseline by the investigator and pharmacist, supported by a health diary and educational flyer. Monthly reinforcement visits will then be carried out at the participants’ homes by trained health workers for 9 months. The intervention includes counselling on recognition of exacerbations, medication adherence, correct inhaler technique, lifestyle modification (smoking cessation, nutrition, physical activity), stress management (breathing techniques and yoga), vaccination counselling, and reduction of air pollution exposure. Baseline assessment will include sociodemographic details, spirometry (FEV1 percent predicted), and health-related quality of life measured using the St. George’s Respiratory Questionnaire (SGRQ). Follow-up will consist of telephonic interviews at 3 and 6 months, and an endline assessment at 9 months. The primary outcome is change in SGRQ score; secondary outcomes include lung function, frequency of acute exacerbations, and healthcare utilization.

 

 
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