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CTRI Number  CTRI/2021/04/032490 [Registered on: 01/04/2021] Trial Registered Prospectively
Last Modified On: 02/04/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The prevalence of anxiety and depression, measured objectively, in patients diagnosed to have asthma and COPD attending a teaching hospital 
Scientific Title of Study   The prevalence of anxiety and depression in diagnosed obstructive airway diseased patients attending a tertiary care centre a cross sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhadra Sajeev Nair 
Designation  M.B.B.S Student 
Affiliation  Malankara orthodox syrian church medical college hospital 
Address  Chandramangalam, Thonnanmakkil(H), Ettumanoor P.O Kottayam, kerala, India 686631
Department of Pulmonary medicine, room no-12 faculty block, Malankara orthodox syrian church medical college hospital,Kolenchery, Ernakulam, India 682311
Kottayam
KERALA
686631
India 
Phone  9061700569  
Fax    
Email  bhadranair718@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jijo Oommen Roy 
Designation  Consultant pulmonologist 
Affiliation  Malankara orthodox syrian church medical college hospital 
Address  Department of Pulmonary medicine, room no-12 faculty block, Malankara orthodox syrian church medical college hospital,Kolenchery, Ernakulam, India 682311
Department of Pulmonary medicine, room no-12 faculty block, Malankara orthodox syrian church medical college hospital,Kolenchery, Ernakulam, India 682311
Ernakulam
KERALA
682311
India 
Phone  8606385885  
Fax    
Email  drjijoroy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhadra Sajeev Nair 
Designation  M.B.B.S Student 
Affiliation  Malankara orthodox syrian church medical college hospital 
Address  Chandramangalam, Thonnanmakkil(H), Ettumanoor P.O Kottayam, Kerala, India 686631
Department of Pulmonary medicine, room no-12 faculty block, Malankara orthodox syrian church medical college hospital,Kolenchery, Ernakulam, India 682311
Kottayam
KERALA
686631
India 
Phone  9061700569  
Fax    
Email  bhadranair718@gmail.com  
 
Source of Monetary or Material Support  
Indian council of medical research (ICMR), Short term studentship(STS) scholarship 2020 
 
Primary Sponsor  
Name  Indian council of medical research ICMR 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
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 
Bhadra Sajeev Nair  Malankara Orthodox Syrian Church Medical College Hospital  Department of Pulmonary medicine, Room no 12- Faculty department Kolenchery, Ernakulam, India 682311
Ernakulam
KERALA 		 9061700569

bhadranair718@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics commiittee Malankara orthodox syrian church medical college hospital  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, (2) ICD-10 Condition: J459||Other and unspecified asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Diagnosed asthma and COPD male and female patients above 18 years of age was included 
 
ExclusionCriteria 
Details  Uncooperative patients and patients below 18 years of age were excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The prevalence of anxiety and depression in diagnosed asthma and chronic obstructive lung disease(COPD) patients attending a respiratory medicine out patient department (OPD) of a developing country  2 months  
 
Secondary Outcome  
Outcome  TimePoints 
Association between severity of anxiety and depression with levels of asthma and chronic obstructive lung disease(COPD) in diagnosed patients  3 Months 
 
Target Sample Size   Total Sample Size="77"
Sample Size from India="77" 
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)   02/04/2021 
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="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  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 [bhadranair718@gmail.com].

  6. For how long will this data be available start date provided 01-01-2022 and end date provided 01-01-2027?
    Response - Immediately following publication. No end date.

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

It is found that there is an increased incidence of Anxiety and Depression in patients with Obstructive Airway Diseases, as compared to general population. But prevalence of the issue as well as number of studies relating to it is very less in developing countries such as India.

My study pose to estimate the prevalence of Anxiety and Depression in diagnosed Asthma and COPD patients objectively using Generalised Anxiety Disorder (GAD-7) and Patient Health Questionnaire (PHQ-9) scales respectively, and the data will be analysed statistically.

The level of asthma and COPD will be assessed by the consultant pulmonologist using Global Initiative for Asthma (GINA) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines respectively.

The Anxiety and Depression score obtained from GAD-7 and PHQ-9 scales respectively will be assessed along with the levels of Asthma and COPD obtained from GINA and GOLD guidelines and relation between the two will be statistically analysed.


 
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