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CTRI Number  CTRI/2024/12/078542 [Registered on: 24/12/2024] Trial Registered Prospectively
Last Modified On: 25/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Screening
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Effect of Health Educational Intervention on Sickle Cell Disease 
Scientific Title of Study   Effect of Health Educational Intervention on early detection of Sickle Cell Disease among Adolescent population in tribal areas of East Singhbhum district , Jharkhand  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sarbasree Bhattacharjee 
Designation  Dr.T.M.A Pai Research Scholar 
Affiliation  Manipal Tata Medical College  
Address  Department of Community Medicine Manipal Tata Medical College, Jamshedpur, Jharkhand

Purbi Singhbhum
JHARKHAND
831017
India 
Phone  918622026752  
Fax    
Email  sarbasree.mtmcjsr2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jarina Begum  
Designation  Professor 
Affiliation  Manipal Tata Medical College  
Address  Department of Community Medicine Manipal Tata Medical College, Jamshedpur, Jharkhand

Purbi Singhbhum
JHARKHAND
831017
India 
Phone  9618162611  
Fax    
Email  jarina.begum@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Jarina Begum  
Designation  Professor 
Affiliation  Manipal Tata Medical College  
Address  Department of Community Medicine Manipal Tata Medical College, Jamshedpur, Jharkhand

Purbi Singhbhum
JHARKHAND
831017
India 
Phone  9618162611  
Fax    
Email  jarina.begum@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Tata Medical College ,Kadani Road,Baridih Jamshedpur, Jharkhand, India PIN 831017 
 
Primary Sponsor  
Name  Sarbasree Bhattacharjee 
Address  Department of Community Medicine Manipal Tata Medical College, Jamshedpur, Jharkhand 
Type of Sponsor  Other [Self] 
 
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 
Dr Jarina Begum  Manipal Tata Medical College  Department of Community Medicine, Manipal Tata Medical College, Kadani Road, Baridih, Jamshedpur, Jharkhand
Purbi Singhbhum
JHARKHAND 
9618162611

jarina.begum@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manipal Tata Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sickle Cell Disease (D57) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Educational Intervention  Knowledge and awareness of sickle cell disease and its effect on early detection/screening for 24 months 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  19.00 Year(s)
Gender  Both 
Details  1.Must be enrolled in a government school
2.Participants who gave assent for the study and received consent from their guardians 
 
ExclusionCriteria 
Details  1.Participants who are planning to transfer to another school before the study concludes.
2. Those participants who were absent on any of the visits. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Baseline Knowledge Attitude assessment of Adolescents on SCD.
Increased Awareness of SCD among adolescents .
Early detection of SCD & anemia among adolescents
perspective of stakeholders regarding Sickle Cell Anemia Elimination Program  
Baseline, Post Test and 3 months after post test 
 
Secondary Outcome  
Outcome  TimePoints 
1. Reduction of SCD by tailor-made counselling based on participants screening results.
2. Inclusion of awareness sessions as a part of the school curriculum of Jharkhand.
3. Evidence-based recommendations to the policymakers for optimizing the effectiveness of current interventions and enhancing support for affected individuals and communities.
4. Development of strategic interventions through the identification of specific needs and disparities among tribal and non-tribal groups related to sickle cell disease.
 
1 year
2 years
2 years 
 
Target Sample Size   Total Sample Size="360"
Sample Size from India="360" 
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)   06/01/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sarbasree.29@gmail.com].

  6. For how long will this data be available start date provided 01-12-2025 and end date provided 31-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Title: Effect of Health Educational Intervention on Early Detection of Sickle Cell Disease among Adolescents in Tribal Areas of East Singhbhum District, Jharkhand

Introduction: Sickle cell disease (SCD) is a genetic blood disorder affecting millions globally, particularly individuals from Africa, the Mediterranean, and South Asia. India carries one of the highest burdens of SCD, and tribal population is notably affected. This study focuses on raising awareness and early detection of SCD among adolescents in government schools in East Singhbhum. SCD results from a genetic mutation that leads to abnormal hemoglobin (HbS), causing red blood cells to deform and impair circulation, leading to pain, anemia, and organ damage. Tribal populations in India, particularly in Jharkhand, are at high risk for SCD. As per Ministry of Tribal Affairs data, 1 in 86 births in tribal population in affected with Sickle Cell Disease. Although awareness and screening efforts have been initiated, gaps in knowledge and healthcare access persist, especially in rural and underserved communities.

Objectives:

1. Create awareness among adolescents in Government Schools towards sickle cell disease.

2. Conduct Participants Screening and early detection   for anemia and sickle cell disease, followed by counselling and referral among adolescents of the Government School.

3. Evaluate the perceptions of all stakeholders regarding the National Sickle Cell Anemia Elimination Mission,2023(NSCAEM).

4. To conduct a scoping review and map the existing literature on sickle cell disease among adolescents.

Methodology: The study employs a Sequential Explanatory Mixed-Methods Design. The quantitative phase involves administering questionnaires to assess knowledge and attitudes before and after health education interventions.  This questionnaire will be a close ended structured questionnaire developed by us .A follow-up will be conducted after three months to evaluate knowledge retention. Adolescents will also be screened for anemia through hemoglobin assessments and SCD through solubility tests.The qualitative phase involves in-depth interviews with stakeholders, including healthcare providers, ASHA workers,Principals, Teachers, patients, and caregivers, to understand healthcare barriers and perceptions related to SCD management and the NSCAEM,2023.

Significance of the Proposed Research Study

1.     Early Detection and Treatment: This study aims to mitigate the effects of the disease and improve health outcomes by detecting cases at an early stage.

2.     Increased Awareness and Education: Targeted educational interventions will help raise awareness, promote early detection, and empower adolescents to make informed decisions, particularly regarding carrier screening and genetic counselling.

3.     Addressing Socio-Demographic Inequalities: The study will compare socio-demographic factors between Scheduled Tribe (ST) and Non-Scheduled Tribe (Non-ST) adolescents, aiming to uncover specific needs and disparities with equitable healthcare solutions and interventions tailored to the unique challenges of each group.

4.     Evaluating Program Effectiveness: By assessing the perceptions of key stakeholders on the National Sickle Cell Anemia Elimination Mission,2023 (NSCAEM), the research will provide valuable insights into its implementation.

5.     Informing Policy and Practice: Using a mixed-methods approach, the study will generate comprehensive data on knowledge, attitudes, and barriers surrounding SCD. These findings will guide policy decisions, improve resource allocation, and enhance public health interventions for better management of the disease.

6.     Improving Access to Healthcare: The research will identify obstacles hindering access to healthcare services, enabling the development of strategies to address these barriers. Expected Immediate Outcomes:

  1. Establishment of baseline knowledge on SCD among adolescents.
  2. Enhanced awareness of SCD in the adolescent population.
  3. Early detection of SCD and anemia among adolescents.
  4. Identification of specific healthcare needs and disparities between tribal and non-tribal adolescents.
  5. Creation of targeted Information, Education, and Communication (IEC) materials for health education.
  6. Insights into the effectiveness and areas for improvement in the NSCAEM.
  7. A deeper understanding of non-program-related barriers to healthcare access.
  8. Generation of a representative data sample on adolescents, leading to publications and intellectual property (IEC material).

Future Scope:

  1. Reduction in the prevalence of SCD through personalized counselling based on screening results.
  2. Integration of SCD awareness sessions into the school curriculum in Jharkhand.
  3. Evidence-based recommendations to policymakers to enhance the effectiveness of current interventions and increase support for affected individuals.
  4. Development of strategic interventions based on the specific needs and disparities identified between tribal and non-tribal populations.
 
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