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CTRI Number  CTRI/2020/09/028165 [Registered on: 30/09/2020] Trial Registered Prospectively
Last Modified On: 27/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A cross sectional study to identify the symptoms that are presenting by COVID-19 suffering people in Bangladesh 
Scientific Title of Study   Symptoms presentation among the COVID-19 survivors in Bangladesh 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammad Anwar Hossain 
Designation  Senior Consultant & Head of Physiotherapy Department 
Affiliation  Centre for the Rehabilitation of the Paralysed (CRP) 
Address  CRP, Chapain, Savar, Dhaka-1343
Department of Physiotherapy, CRP, Savar, Dhaka


1343
Other 
Phone  01753559949  
Fax    
Email  anwar_physiobd@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Mohammad Anwar Hossain 
Designation  Senior Consultant & Head of Physiotherapy Department 
Affiliation  Centre for the Rehabilitation of the Paralysed (CRP) 
Address  CRP, Chapain, Savar, Dhaka-1343
Department of Physiotherapy, CRP, Savar, Dhaka


1343
Other 
Phone  01753559949  
Fax    
Email  anwar_physiobd@yahoo.com  
 
Details of Contact Person
Public Query  
Name  KM Amran Hossain 
Designation  Lecturer 
Affiliation  Bangladesh Health Professions Institute (BHPI) 
Address  Bangladesh Health Professions Institute (BHPI), CRP, Savar, Dhaka-1343
MPT program, Department of Physiotherapy, BHPI, CRP, Savar, Dhaka


1343
Other 
Phone  01735661492  
Fax    
Email  amranphysio@gmail.com  
 
Source of Monetary or Material Support  
Centre for the Rehabilitation of the Paralysed (CRP) 
 
Primary Sponsor  
Name  Mohammad Anwar Hossain 
Address  Department of Physiotherapy, CRP, Savar, Dhaka-1343 
Type of Sponsor  Other [Self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mohammad Anwar Hossain  Centre for the Rehabilitation of the Paralysed (CRP)  CRP, Chapain, Savar, Dhaka-1343 Department of Physiotherapy

 		 01753559949

anwar_physiobd@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
CRP Ethics Committee, Centre for the Rehabilitation of the Paralysed (CRP)  Approved 
The Institutional Review Board, Institute of Physiotherapy Rehabilitation and Research, BPA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Patients who will be diagnosed COVID-19 positive by RT-PCR test.
2.The age range will be above 18 years because usually affected COVID-19 in elderly age and younger age people will affect but not more susceptible
3.Male and female will be same prioritized although more male is more at risk  
 
ExclusionCriteria 
Details  1.Patients who will be the severe physical illness that they are unable to communicate with others.
2. Patients who are below 18 years old
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study will be the pain types and severity, muscle strength, cardio-respiratory functioning among the COVID-19 survivors in Bangladesh  Primary outcomes of this will be calculated after 3 months of data collection.  
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcome of the study will be coping strategy, quality of life. post covid 19 functional status among the COVID-19 survivors in Bangladesh  2 months after discharge 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/10/2020 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Not Applicable 
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-identification.

  2. What additional supporting information will be shared?
    Response - None of the above

  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 (Others) -  Data are available at third party website or repository

  6. For how long will this data be available start date provided 30-04-2021 and end date provided 30-06-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - N/A
Brief Summary   Title: Symptoms presentation among the COVID-19 survivors in Bangladesh

Aims and Objectives:

Aim: Aim of this study will be to identify the presence of the symptoms that have been suffering by the COVID-19 survivors. 

Objectives:

·         To know the Socio-demographic characteristics data of COVID-19 survivors.

·         To identify the level of physical limitation of the COVID-19 survivors.

·         To evaluate the functional barriers that have been experienced by COVID survivors.

Conceptual framework

Independent variables

Dependent variable

Socio-demographic status

 

Symptoms presentation

COVID-19 survivors

Co-morbidity

 


Study design: Cross-sectional study

Study Population:

Patients who will be previously diagnosed COVID-19 positive in RT-PCR test and recovered from COVID-19 positive status in Bangladesh

Study area:

COVID affected patients who will be residents in Bangladesh will be a targeted population in this study. So the whole of Bangladesh will be selected as the study area

Sampling technique

The researcher will use a snowball sampling method to select samples as the sampling technique. The chain referral process of the snowball sampling technique will allow the researcher to reach populations that difficult to sample when using other sampling methods. The process is cheap, simple, and co-efficient.

Outcome measurements tools

1.      Self-structured Socio-demographic information

2.      COVID-19 exposure and symptoms related questionnaire.

3.      Self-administered Co-morbidity Questionnaire

4.      Post-COVID-19 Functional Status (PCFS) Scale

5.      Brief-Coping scale

6.      WHO Quality of Life questionnaire  (WHO QoL BREF)

7.      The Örebro Musculoskeletal Pain Questionnaire (ÖMPQ)

Data Collection Procedure

Face to face interview of the COVID-19 survivor patients

Cross-sectional studies will give us information about the prevalence of outcomes or exposures; this information will be useful for designing a cross-sectional study. Findings from this study will help us to understand the symptoms characteristics of COVID survived patients who will be suffering long term impairments

Data analysis

Data will be analyzed by SPSS 22 version and Microsoft Excel 13. The statistical test will select according to the nature of the Data.

Data audit

An external auditor will examine the data and all the data will keep at a data repository.

 
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