| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Informed Consent Form
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sarbasree.29@gmail.com].
- 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.
- 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:
- Establishment
of baseline knowledge on SCD among adolescents.
- Enhanced
awareness of SCD in the adolescent population.
- Early
detection of SCD and anemia among adolescents.
- Identification
of specific healthcare needs and disparities between tribal and non-tribal
adolescents.
- Creation of
targeted Information, Education, and Communication (IEC) materials for
health education.
- Insights
into the effectiveness and areas for improvement in the NSCAEM.
- A deeper
understanding of non-program-related barriers to healthcare access.
- Generation
of a representative data sample on adolescents, leading to publications
and intellectual property (IEC material).
Future Scope:
- Reduction
in the prevalence of SCD through personalized counselling based on
screening results.
- Integration
of SCD awareness sessions into the school curriculum in Jharkhand.
- Evidence-based
recommendations to policymakers to enhance the effectiveness of current
interventions and increase support for affected individuals.
- Development
of strategic interventions based on the specific needs and disparities
identified between tribal and non-tribal populations.
|