| CTRI Number |
CTRI/2024/06/069241 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the effect of nurse led pulmonary intervention on pulmonary function and quality of life among coal mine workers with respiratory disorders |
|
Scientific Title of Study
|
A study to assess the prevalence of respiratory disorders among workers of coal mines and effectiveness of nurse led pulmonary interventional package on pulmonary function and quality of life among them in selected coal mines of Jharkhand |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Athira B |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Deoghar |
| Address |
Department: College of Nursing
Division : Nursing
Room No. 2
Academic Block, AIIMS Deoghar,
Devipur, Deoghar
Deoghar
JHARKHAND
814152
India |
| Phone |
8129357822 |
| Fax |
|
| Email |
athira.nur@aiimsdeoghar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushma Saini |
| Designation |
Associate Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department: National Insitute of Nursing Education
Division: Community health nursing
Room No 211, PGIMER SEctor 12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888038248 |
| Fax |
|
| Email |
sushmadrsaini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Athira B |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Deoghar |
| Address |
Department: College of Nursing
Division: Nursing
Room no.2
Academic Block, AIIMS Deoghar, Devipur, Deoghar
Deoghar
JHARKHAND
814152
India |
| Phone |
8129357822 |
| Fax |
|
| Email |
athira.nur@aiimsdeoghar.edu.in |
|
|
Source of Monetary or Material Support
|
| Central Hospital, Koyla Bhawan, Koyla Nagar, Dhanbad, 826005 |
|
|
Primary Sponsor
|
| Name |
Athira B |
| Address |
Department: College of Nursing
Division: Nursing
Room No.2
Academic Block, AIIMS Deoghar, Devipur, Deoghar |
| Type of Sponsor |
Other [Other ( self)] |
|
|
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 |
| Dr C Vasantha Kalyani |
All India Institute of Medical Sciences, Deoghar |
Department : College of Nursing
Division: Nursing
Room No.1
Academic Block, AIIMS Deoghar, Devipur
Deoghar
JHARKHAND |
8129357822
vasantha.nur@aiimsdeoghar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS DEOGHAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J41||Simple and mucopurulent chronic bronchitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Nurse led pulmonary interventional package |
Frequency: 4 to 5 days in a week
Duration: 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Male |
| Details |
Persons working or retired from coal mines, with respiratory disorders, Peak flow rate of more than 250L/minute and Medical Research Dyspnea Scale grade 3 |
|
| ExclusionCriteria |
| Details |
Persons not willing to participate and those with severe illnesses which compromise exercise training |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Peak Expiratory Flow rate
Dyspnea Level
Quality of Life Score |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hospital readmission rate |
3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
03/07/2024 |
| 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="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 - NO
|
|
Brief Summary
|
this study is a non randomised control trial assessing the effectiveness of nurse led pulmonary interventional package on pulmonary function and quality of life among coal mine workers with respiratory disorders in selected coal mines of Jharkhand, India. the primary outcome measures will be Pulmonary function( assessed by Peak expiratory flow rate and Medical Research Council Dyspnea Scale) and Quality of life( assessed by St. George Respiratory Questionnaire) at 3 months. |