FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/10/095612 [Registered on: 06/10/2025] Trial Registered Prospectively
Last Modified On: 04/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of One-Shot Nursing Intervention on Dyspnoea and Activities of Daily Living in Patients with COPD 
Scientific Title of Study   An Experimental Study to Assess the Effectiveness of One-Shot Nursing Intervention on Dyspnoea and Activities of Daily Living in Patients with COPD in the Pulmonary OPD of a Selected Tertiary Care Hospital 
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 K Jayakrishnan 
Designation  Tutor 
Affiliation  All India Institute of Medical Sciences Kalyani 
Address  College of Nursing Building, 2nd Floor, AIIMS Kalyani Campus, Saguna, Basantapur PO, Kalyani

Nadia
WEST BENGAL
741245
India 
Phone  9348310322  
Fax    
Email  kjayakrishnan.nursing@aiimskalyani.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr K Jayakrishnan 
Designation  Tutor 
Affiliation  All India Institute of Medical Sciences Kalyani 
Address  College of Nursing Building, 2nd Floor, AIIMS Kalyani Campus, Saguna, Basantapur PO, Kalyani

Nadia
WEST BENGAL
741245
India 
Phone  9348310322  
Fax    
Email  kjayakrishnan.nursing@aiimskalyani.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr K Jayakrishnan 
Designation  Tutor 
Affiliation  All India Institute of Medical Sciences Kalyani 
Address  College of Nursing Building, 2nd Floor, AIIMS Kalyani Campus, Saguna, Basantapur PO, Kalyani

Nadia
WEST BENGAL
741245
India 
Phone  9348310322  
Fax    
Email  kjayakrishnan.nursing@aiimskalyani.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr K Jayakrishnan 
Address  College of Nursing, AIIMS Kalyani, Basantapur, Saguna, Kalyani, West Bengal - 741245 
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 Mahesh Ravikumar Jansari  All India Institute of Medical Sciences Kalyani  417, 4th Floor, Department of Pulmonary Medicine, AIIMS Kalyani Hospital, Saguna, Basantapur PO, Kalyani
Nadia
WEST BENGAL 		 8655892055

mahesh.pulmonary@aiimskalyani.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Medical Sciences, Kalyani  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  No Intervention  The participants in the control group will not receive any intervention from the researcher during the study period. 
Intervention  One Shot Nursing Intervention  This intervention provides educative measures on the skills of use of spacers and deep breathing exercises as well as knowledge on disease-appropriate nutrition and energy conservation methods for people with COPD. The intervention would be provided by nurses, and would be completed within 30 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Patient diagnosed with COPD for atleast 6 months.
2. Patient who are willing to participate in the study.
3. Patients who understand either English, Hindi or Bengali. 
 
ExclusionCriteria 
Details  Patients with compromised cardiopulmonary conditions. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Activities of daily living  Baseline, 7 days & 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Level of Breathlessness  Baseline, 7 days & 30 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/10/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be made available on reasonable request to the primary author.

  6. For how long will this data be available start date provided 01-09-2026 and end date provided 01-09-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is conducted to evaluate the effectiveness of nurse-led brief intervention (One Shot Nursing intervention), which could be provided at the outpatient settings for patients with COPD, so that their exacerbations could be reduced and their activities of daily living could be improved. This study, if found effective, could lead the way in utilizing nurse-led brief interventions in various other conditions and/or departments. In a busy setting, brief interventions would prove more efficient and compliant among the participants. The study hypothesizes that there will be a change in the level of activities of daily living and the number of acute exacerbations after the administration of one-shot nursing interventions. 
Close