| CTRI Number |
CTRI/2025/01/079768 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Behavioral
Other (Specify) [Health Education] |
| Study Design |
Other |
|
Public Title of Study
|
Improving Care for Sickle Cell Disease in Tribal Communities in India |
|
Scientific Title of Study
|
Optimizing strategies for enhancing Sickle Cell Disease management in tribal population: A multi-centric implementation research |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanveer Rehman |
| Designation |
Scientist-B (Medical) |
| Affiliation |
ICMR Regional Medical Research Centre, Bhubaneswar |
| Address |
ICMR Regional Medical Research Centre, Bhubaneswar
Nalco Nagar, Chandrasekharpur, Bhubeneswar
Khordha
ORISSA
751023
India |
| Phone |
8336922482 |
| Fax |
|
| Email |
drtanveerrehman@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanveer Rehman |
| Designation |
Scientist-B (Medical) |
| Affiliation |
ICMR Regional Medical Research Centre, Bhubaneswar |
| Address |
ICMR Regional Medical Research Centre, Bhubaneswar
Nalco Nagar, Chandrasekharpur, Bhubeneswar
Khordha
ORISSA
751023
India |
| Phone |
8336922482 |
| Fax |
|
| Email |
drtanveerrehman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanveer Rehman |
| Designation |
Scientist-B (Medical) |
| Affiliation |
ICMR Regional Medical Research Centre, Bhubaneswar |
| Address |
ICMR Regional Medical Research Centre, Bhubaneswar
Nalco Nagar, Chandrasekharpur, Bhubeneswar
Khordha
ORISSA
751023
India |
| Phone |
8336922482 |
| Fax |
|
| Email |
drtanveerrehman@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Health Research (DHR)
Under Ministry of Health and Family Welfare
2ND Floor, IRCS Building, 1, Red Cross,
New Delhi- 110001 |
|
|
Primary Sponsor
|
| Name |
Department of Health Research (DHR), Ministry of Health and Family Welfare |
| Address |
2nd Floor, IRCS Building,
1, Red Cross Road, New Delhi
PIN- 110001 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Piyoosh Kumar Singh |
Model Rural Health Research Unit, Angara |
Community Health Centre Angara campus,
Purulia Road, Angara block
PIN- 835103
Ranchi
JHARKHAND |
9540625580
drpksingh45@gmail.com |
| Dr Ravindra Kumar |
Model Rural Health Research Unit, Jheet |
Community Health Centre Patan campus,
Patan block
PIN- 491111
Durg
CHHATTISGARH |
7999502429
ravindrachhabra@gmail.com |
| Dr Tanveer Rehman |
Model Rural Health Research Unit, Namkum |
Ground Floor, ICMR- National Institute of Malaria Research building,
Institute of Public Health campus,
National Highway 33, Namkum block
PIN- 834010
Ranchi
JHARKHAND |
8336922482
drtanveerrehman@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, ICMR NIRTH Jabalpur |
Approved |
| Institutional Ethics Committee, ICMR- National Institute of Malaria Research |
Approved |
| Institutional Human Ethics Committee, ICMR RMRC Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
People aged 18 years and above residing in districts and villages with higher prevalence of Sickle Cell disease or trait. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Health Education |
Health education and training will be given to the healthcare workers (Doctors, Nurses, Community Health Officers, Auxillary Nurse Midwives, Accredited Social Health Activists) and school teachers regarding Sickle Cell Disease, its cause, symptoms, prevention and management. Further the effect of the intervention will be assessed by examining the community members and school children by conducting questionnaire-based surveys and engagement activities and discussions (Quiz). The complete study duration is 2 years and the duration for the Health Education intervention is 9 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) For Pre and Post Intervention Survey: Residents of the study site aged 18 years and above
2) Intervention: We will provide health education sessions regarding information on Sickle Cell Disease in the community and schools. In schools we will conduct training for the school teachers and will assess the effect of the training by conducting pre and post surveys using questionnaire with school children aged 10 and above.
In the community, we will provide training to health workers and will assess the effect by conducting surveys among the residents aged 18 years and above. |
|
| ExclusionCriteria |
| Details |
1) People who are critically ill
2) People who have been resident of the study site for less than 6 months |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increased awareness about Sickle Cell Disease in the community due to health education to the healthcare providers and community members. |
The total study period is of 2 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced births with Sickle Cell Disease due to the effect of health education and genetic counseling. |
Long term |
| Early detection of SCD and intervention |
2 years |
| Improved knowledge about SCD and reduced stigma in the community. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="1356"
Sample Size from India="1356"
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)
|
03/03/2025 |
| 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="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this pre and post-intervention study, we will conduct survey using a questionnaire in the community in three study sites, two in Jharkhand and one in Chhattisgarh, having high prevalence of Sickle Cell Disease. The survey will be conducted before and after the intervention to assess the knowledge regarding SCD among the people and to determine the effect of health education. For this, we will recruit participants aged 18 years and above. We will also conduct qualitative interviews among healthy people, SCD patients, caregivers and healthcare providers to explore the barriers and facilitators of management of SCD. Intervention- The study intervention involves training and health education of healthcare providers, school teachers and local leaders at community, schools/colleges and health facilities. The study will be conducted for a period of two years. The effect of these trainings will be assessed in the community and school. We will conduct engagement sessions at schools, eg., quizzes involving children aged 10 years and above and in the community to understand if these trainings have been useful in improving knowledge about SCD in the community. |