| CTRI Number |
CTRI/2022/12/048580 [Registered on: 29/12/2022] Trial Registered Prospectively |
| Last Modified On: |
24/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Checking the prevalence of psychiatric comorbidity and quality of life in Chronic Obstructive Pulmonary Disease patients. |
|
Scientific Title of Study
|
Psychiatric comorbidity and quality of life in individuals with chronic obstructive pulmonary disease- 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 |
DR COL S DIXIT |
| Designation |
PROFESSOR AND HEAD, PSYCHIATRY |
| Affiliation |
RohilKhand Medical College and Hospital |
| Address |
ROOM NO 201 , ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9650010992 |
| Fax |
|
| Email |
sid68sify@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR COL S DIXIT |
| Designation |
PROFESSOR AND HEAD, PSYCHIATRY |
| Affiliation |
RohilKhand Medical College and Hospital |
| Address |
ROOM NO 201 , ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9650010992 |
| Fax |
|
| Email |
sid68sify@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Shubham Sharma |
| Designation |
Junior resident |
| Affiliation |
RohilKhand Medical College and Hospital |
| Address |
Room No- 201,Department of Psychiatry, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, BAREILLY
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7500061000 |
| Fax |
|
| Email |
shubham.upmanyu95@gmail.com |
|
|
Source of Monetary or Material Support
|
| RohilKhand medical college and hospital |
|
|
Primary Sponsor
|
| Name |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
| Address |
PILIBHIT BYPASS ROAD BAREILLY, 0581 2526152 |
| Type of Sponsor |
Private medical college |
|
|
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 Col S Dixit |
RohilKhand medical college and hospital |
Room no. 2090,1st floor,department of psychiatry
Bareilly
UTTAR PRADESH |
9650010992
sid68sify@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC/RMCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F54||Psychological and behavioral factors associated with disorders or diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.) patients with written informed consent will be taken for the study.
2.) All patients diagnosed by pulmonary medicine consultant as COPD and referred to psychiatry OPD will be taken for the study.
3.) age range: 30-80 |
|
| ExclusionCriteria |
| Details |
1.) patients with history of known mental disorder will be excluded from study.
2.) patients with uncontrolled chronic physical illnesses such as hypertension,hypothyroidism,congestive heart failure, cerebrovascular accident and diabetes mellitus will be excluded from this study.
3.) patients of COPD presenting with sudden and severe exacerbation of symptoms. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.) prevalence of psychiatric morbidity |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life in copd patients |
2 years |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
30/12/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The goal of this study is to find the prevalence of psychiatric co morbidities like depression,mania,anxiety,ocd,phobia and assess the QOL in COPD patients so that they can be given the required care and treatment and thus help in making the prognosis more favourable for them. |