| CTRI Number |
CTRI/2024/09/074289 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of National Programme for Non-communicable Diseases(NPNCD) in Rural Bhavnagar |
|
Scientific Title of Study
|
An Evaluation of National Programme for Prevention and control of Non-communicable Diseases(NPNCD) in Rural areas of Bhavnagar District– A Cross Sectional Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shubham H Patel |
| Designation |
Resident Doctor |
| Affiliation |
Government Medical college,Bhavanagar. |
| Address |
Department of Community Medicine, Government Medical College, Jail road, Bhavnagar- 364001.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9265684353 |
| Fax |
|
| Email |
patelshubham1008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrKailesh D Bhalani |
| Designation |
Associate professor |
| Affiliation |
Government Medical college,Bhavnagar |
| Address |
Department of Community Medicine, Government Medical College, Jail road, Bhavnagar- 364001.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427287722 |
| Fax |
|
| Email |
kdbhalani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Kailesh D Bhalani |
| Designation |
Associate professor |
| Affiliation |
Government Medical college,Bhavnagar |
| Address |
Department of Community Medicine, Government Medical College, Jail road, Bhavnagar- 364001.
Bhavnagar
GUJARAT
364001
India |
| Phone |
9427287722 |
| Fax |
|
| Email |
kdbhalani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Government Medical College Bhavnagar |
| Address |
Department of Community Medicine, Government Medical College,Jail road Bhavnagar- 364001.
|
| Type of Sponsor |
Government medical college |
|
|
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 Shubham Patel |
Rural Bhavnagar District. |
Bhavnagar, Gujarat
Bhavnagar
GUJARAT |
9265684353
patelshubham1008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Commmitte Government Medical College,Bhavnagar. |
Approved |
| Rural District NOC From CDHO Office |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Screening |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. People of Age 30 years and above for screening coverage and referral compliance.
2. ASHA of selected area/Village.
|
|
| ExclusionCriteria |
| Details |
1. People living in the houses, which are closed at the time of the visit.
2. People who will not provide verbal consent for assessment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Screening Coverage of NCDs
Referral compliance of Participants for NCD.
|
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Referral compliance of Participants for NCD.
2.Availability of Resources at ABHWC(Ayushman Bharat Health And wellness centres.
3.ASHA workload and time spent on Non communicable Diseases. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="960"
Sample Size from India="960"
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)
|
01/11/2024 |
| 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="0"
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
|
1. Approval from Ethics committee . 2. Permission from CDHO for accessing the District NCD Cell Data and conducting the study. 3. 30 AB-HWCs will selected randomly from Total 251 AB-HWCs of District 4. 1 village (1 ASHA area) will be selected randomly from each of the selected AB-HWCs. 5. Data reported by 30 ASHAs and 30 CHOs will be taken from District NCD cell. 6. 32 Houses will be visited from each of the selected village. Whole village will be virtually divided into 4 sections from the center of the village and from all the sections, 8 houses will be selected. 1st house from each section will be selected randomly and then subsequently 8 consecutive houses will be visited from that section. 7. In case of any of the selected house will be found closed, next consecutive house will be visited and Data will be collected. 8. An additional visit of the house will be made at their convenient time, if information of all the eligible participants could not be collected from any house due to any reason. 9. Each of the selected houses will be visited and information about the screening coverage, referral compliance (NPNCD) & current health and treatment status of all the family members above 30 years of age will be collected. 10. Information about availability of resources will be collected from ASHA and CHO. 11 . ASHA worker of selected area will be interviewed for the assessment of their workload and time spent for NPNCD related activities. 12. Data entry will be done in Excel sheet and Data analysis will be done in JAMOVI software. |