Clinical Study Protocol (Sample)

Study Title: The Impact of Covid -19 Pandemic on the Psychological Wellbeing of Healthcare Professionals in India.

Table of Contents:

Background and Introduction

Many studies have shown previous infectious diseases epidemics to cause severe long term and persistent psychological consequences. In this fight against Covid 19, healthcare professionals played a significant role and may undergo severe psychological stress. Just like several studies have reported, healthcare professionals appeared to suffer from severe long lasting psychological problems including anxiety, depression, insomnia etc. They are exposed to long work hours to meet the growing healthcare demand. Factors like lack of social support, poor sleep quality, isolation from friends, fear of spreading the disease to their families, co-workers, and direct contact with Covid 19 patients trigger the psychological stress. Wearing protective equipment gears during work hours cause respiratory discomfort along with restricted mobility also aggravate the psychological symptoms.

Study rationale

There is a likelihood of psychological distress impacting healthcare professionals mental well being as a result of their role in healthcare setup during the Covid 19 pandemic thereby affecting the quality of life.

Study Objectives

A) Primary Objective – This study is aimed to evaluate the epidemiology of psychological distress among healthcare professionals during the Covid 19 pandemic.

B) Secondary objective – To assess the implications of providing psychological interventions in the management of psychological distress among healthcare professionals during the Covid 19 pandemic.

Study Design

There are 1295 eligible participants for this category. The participation shall be voluntary and informed consent shall be sought prior to the study initiation. The responses of the participants will remain anonymous with strict confidentiality.

An Observational prospective cohort study design will be implemented. It is a longitudinal cohort study that follows over time a group of similar individual cohorts who differ with respect to certain factors under study to determine how these factors affect rates of a certain outcome. The advantages of such studies are, it can help determine risk factors of being infected with a new disease as they are longitudinal observation over time, they can assess the causality, examine multiple outcomes for a given exposure, the collection of results is at regular time intervals, hence the recall error is minimized.

Study population

1295 healthcare professionals of Max Super speciality Hospital, Saket, New Delhi.

Subject Eligibility

A) Inclusion criteria – Healthcare professionals working in Max Super Speciality Hospital, Saket, New Delhi which includes the doctors, nurses, paramedics, front office employees and all support staff of both sexes who are 18 years and above and residing in India. Eligible participants to be included are 1295.

B) Exclusion Criteria – Non employees of Max Super Speciality Hospital, Saket, New Delhi who reside outside India.

Study Assessments

The questionnaire assessing the psychological wellbeing shall be administered using digital means of communication to healthcare professionals and support staff across Max Super speciality hospital, Saket, New Delhi. The sampling method adopted for the study shall be Probability sample. Time frame for the study shall be 3 months.

Study Conduct

Therapeutic sessions will emphasize on aspects of stress including anxiety, depression, grief, post traumatic impact, loss, fear etc using standardised therapeutic techniques of psychotherapy.

If the subject needs further management or somatic symptomatic treatment, they will be guided for pharmacotherapy.

Resilience building and planning shall be implemented via individual, group, and/or online based training portals to the cohort falling in the range of mild-moderate levels of psychological distress.

Ethical considerations

The study details stated in this protocol shall be performed according to the ethical principles described in the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013), the International Council of Harmonisation Good Clinical Practice (ICH GCP) E6 (R2) and New Drugs and Clinical Trials 2019 introduced by the Government of India.

A) Subject Confidentiality: All reports, CRF and communications related to subjects in the study will identify subjects only by the subject number and protocol number.

B) Interim Study Report: Data will be provided to Data and Safety Monitoring Board on periodic basis and based on their recommendations, interim study report shall be provided to regulatory agencies.

Study monitoring and supervision

Source documents comprising of the original records of clinical findings, observations, hospital records, clinical and office charts, laboratory notes, subject diaries, pharmacy dispensing records, magnetic media, x-rays, subject files and all records kept at the pharmacy, laboratory and medico technical departments of the hospital will be maintained in the permanent files of the investigator and will be available for inspection by the authorised personnel as and when required.

Undertaking by the Investigator

Full name of the Principal Investigator: Hiba Siddiqui

Address: Max Healthcare Institute Limited, Saket, New Delhi

Protocol number: Not Applicable

Version number and Date: Not Applicable

NCT number: NCT04469660

Title: An Observational Prospective Cohort Study to study the impact of Covid -19 pandemic on the psychological wellbeing of healthcare professionals in India.

Commitments:

(i) I have reviewed the clinical protocol and agree that it contains all the necessary information to conduct the study. I will not begin the study until all necessary ethics committee and regulatory approvals have been obtained.

(ii) I agree to conduct the study in accordance with the current protocol. I will not implement any deviation from or changes of the protocol without agreement by the Sponsor and prior review and documented approval or favourable opinion from the ethics committee of the amendment, except where necessary to eliminate an immediate hazard to the trial subject or when the changes involved are only logistical or administrative in nature.

(iii) I agree to personally conduct or supervise the clinical trial at my site.

(iv) I agree to inform all trial subject, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent and ethics committee review and approval specified in the New Drugs and Clinical Trials Rules, 2019 and Good Clinical Practices guidelines are met.

(v) I agree to report to the Sponsor all adverse experiences that occur in the course of the investigation(s) in accordance with the regulatory requirements and Good Clinical Practices guidelines.

(vi) I have read and understood the information in the Investigator’s brochure, including the potential risks and side effects of the drug.

(vii) I agree to ensure that all associates, colleagues and employees assisting in the conduct of the study are suitably qualified and experienced and they have been informed about their obligations in meeting their commitments in the trial.

(viii) I agree to maintain adequate and accurate records and to make those records available for audit or inspection by the Sponsor, ethics committee, Central Licencing Authority or their authorised representatives, in accordance with regulatory provisions and the Good Clinical Practices guidelines. I will fully cooperate with any study related audit conducted by regulatory officials or authorised representatives of the Sponsor.

(ix) I agree to promptly report to the ethics committee all changes in the clinical trial activities and all unanticipated problems involving risks to human subjects or others.

(x) I agree to inform all serious adverse events to the Central Licencing Authority, sponsor as well as the ethics committee within twenty-four hours of their occurrence. In case, of failure to do so, I shall furnish the reason for the delay to the satisfaction of the Central Licencing Authority along with the report of the serious adverse event.

(xi) The report of the serious adverse event, after due analysis, shall also be forwarded by me to the Central Licensing Authority, the Chairperson of the ethics committee and the Head of the institution where the trial has been conducted within fourteen days in accordance with the regulatory requirements.

(xii) I will maintain confidentiality of the identification of all participating subjects and assure security and confidentiality of study data.

(xiii) I agree to comply with all other requirements, guidelines and statutory obligations as applicable to clinical Investigators participating in clinical trials.

Signature of the Investigator with Date: Not Applicable

Appendices

A) Clinical study synopsis

B) Copies of Informed Consent Forms

C) Case Record Forms

D) Data Collection forms

Dr. Sushmita Ganguli