| CTRI Number |
CTRI/2021/05/033870 [Registered on: 31/05/2021] Trial Registered Prospectively |
| Last Modified On: |
29/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Study |
| Study Design |
Other |
|
Public Title of Study
|
Qualitative Study of Health-seeking and Healthcare Availability in COVID patients |
|
Scientific Title of Study
|
Factors influencing health-seeking behavior of and healthcare availability to COVID-19 patients in a tertiary care hospital: A Qualitative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yuvaraj B Chavan |
| Designation |
Additional Professor |
| Affiliation |
KEM Hospital |
| Address |
Community Medicine Dept.
3rd Floor, Library Building,
KEM Hospital,
Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
yuvarajbc@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Yuvaraj B Chavan |
| Designation |
Additional Professor |
| Affiliation |
KEM Hospital |
| Address |
Community Medicine Dept.
3rd Floor, Library Building,
KEM Hospital,
Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
yuvarajbc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Yuvaraj B Chavan |
| Designation |
Additional Professor |
| Affiliation |
KEM Hospital |
| Address |
Community Medicine Dept.
3rd Floor, Library Building,
KEM Hospital,
Parel, Mumbai
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
yuvarajbc@yahoo.co.in |
|
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Source of Monetary or Material Support
|
| Seth GSMC and KEM Hospital, Mumbai, Maharashtra |
|
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Primary Sponsor
|
| Name |
Yuvaraj B Chavan |
| Address |
Department of community medicine, 1st floor, library building, Seth GSMC and KEM Hospital, Mumbai, Maharashtra |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yuvaraj B Chavan |
KEM Hospital |
Department of community medicine, 1st floor, library building, Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel East, Parel, Mumbai
Mumbai
MAHARASHTRA |
9869178407
yuvarajbc@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients admitted to the COVID-19 ward of our tertiary care hospital for the treatment of COVID-19.
2.Patients who are conscious, co-operative, and oriented to time, place, and person and capable of engaging in the in-depth interview. |
|
| ExclusionCriteria |
| Details |
1.Patients who are not mentally stable.
2.Patients not willing to participate. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study will help identify the potential factors influencing health-seeking behavior and outcomes of COVID-19 patients and pinpoint any possible weak links in ensuring good health-seeking behavior, treatment, and outcome of COVID patients, in order to generate research questions for future studies and identify future measures to improve upon these domains.
Due to the qualitative nature of the study, no definite outcome measures. |
The single time point at which the qualitative data will be analysed will be 4 weeks from the start of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study will help identify the potential factors influencing health-seeking behavior and outcomes of COVID-19 patients and pinpoint any possible weak links in ensuring good health-seeking behavior, treatment, and outcome of COVID patients, in order to generate research questions for future studies and identify future measures to improve upon these domains.
Due to the qualitative nature of the study, no definite outcome measures. |
The time point at which the qualitative data will be analysed remains common with that mentioned under primary outcomes, i.e. with the overall data analysis, at 4 weeks from the start of the study. |
|
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Target Sample Size
|
Total Sample Size="6"
Sample Size from India="6"
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)
|
30/06/2021 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The results of the study will be disseminated through publication in a scientific journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
INTRODUCTION:
The COVID-19 pandemic has disrupted normal life throughout the world since early 2020. India has risen to be the country with the second highest number of cases and third highest number of deaths. A major hurdle in reducing the mortality due to COVID-19 has been a lack of timely access to adequate healthcare, for example due to delays in hospital admission. Another emerging problem has been patients’ preferences for receiving treatment at certain hospitals, leading to those hospitals being overwhelmed with cases despite an overall adequacy in the number of beds available. However, data needs to be gathered to consolidate the so far largely anecdotal evidence of inadequate healthcare delivery. Hence, we have formulated this study to highlight the same in a qualitative analysis and yield further information on issues that require broader, quantitative research to be able to build an effective response to pandemics and crises of the future. AIM: To qualitatively study the factors influencing healthcare availability and health seeking
behavior of COVID 19 patients at a tertiary care hospital.
OBJECTIVES:
1. To study the social and demographic profile of COVID 19 patients in a tertiary care
hospital.
2. To study the facilitating and inhibiting factor s influencing health seeking behavior of
COVID 19 patients in a tertiary care hospital.
3.To study the knowledge, attitude, and practices of persons about healthcare availability in the COVID-19 pandemic.
INCLUSION CRITERIA:
1. Patients in the age group of 18 to 60 years.
2. Patients admitted to the COVID 19 ward of our tertiary care hospital for the
treatment of COVID 19.
3. Patients who are conscious, co operative, and oriented to time, place, and person
and whose health conditions are stable enough to enable them to engage in the in
depth interview.
EXCLUSION CRITERIA: 1. Patients who are not mentally stable. 2. Patients not willing to participate.
METHODOLOGY AND ANALYSIS: This is a qualitative study. It will be commenced after receiving approval from the Institutional Ethics Committee, conducted through semi-structured interviews in the patients’ own words in the COVID wards at the tertiary care hospital. Sampling technique used will be purposive sampling. Patients appearing the most stable in the ward and willing to answer the interview schedule will be enrolled purposively. The sample size is 6 participants, based on the recommendation given by Morse (1994) for phenomenological studies. The interview duration will be 15 to 25 minutes. Before this, participants will be given the Informed Consent Document (ICD) and allotted time to ask questions or doubts. Specific consent will be taken for the audio recording of the interviews by the investigator, for the purpose of analysis. Participation in the study will be at no cost to the participant. Therefore, no compensation will be provided. We plan to conduct this study over a period of 1.5 months. Data gathered in this time will be subsequently analysed by Thematic Content Analysis.
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