| CTRI Number |
CTRI/2024/12/077747 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Knowledge and Skills Regarding Non- Communicable disease among ASHA Workers |
|
Scientific Title of Study
|
Assess the Effectiveness of Empowerment Programme for Integrated Screening and Management of Non-Communicable Diseases in terms of Knowledge and Skills among ASHA Workers of selected Community |
| Trial Acronym |
knowledge and skills regarding non-communicable disease |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Jaswal |
| Designation |
Phd scholar |
| Affiliation |
MM Deemed to be University Mullana Ambala |
| Address |
MM college of Nursing,MM deemed to be University Mullana Ambala
Ambala
HARYANA
133207
India |
| Phone |
7357909890 |
| Fax |
|
| Email |
jaswal.pooja94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti sarin |
| Designation |
Professor cum principal |
| Affiliation |
MM Deemed to be University Mullana Ambala |
| Address |
MM college of Nursing,MM deemed to be University Mullana Ambala
Ambala
HARYANA
133207
India |
| Phone |
9643281814 |
| Fax |
|
| Email |
Sarinjyoti@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr jyoti sarin |
| Designation |
Professor cum principal |
| Affiliation |
MM Deemed to be University Mullana Ambala |
| Address |
MM college of Nursing,MM deemed to be University Mullana Ambala
Ambala
HARYANA
133207
India |
| Phone |
9643281814 |
| Fax |
|
| Email |
Sarinjyoti@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| MM deemed to be university mullana |
|
|
Primary Sponsor
|
| Name |
Pooja jaswal |
| Address |
MM college of Nursing, MM deemed to be university mullana Ambala haryana. 133207 |
| 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 BIRBAL |
Rural & Urban Community of Haryana |
ROOM NO 201,BARARA BLOCK COMMUNITY HEALTH CENTRE
AMBALA DIVISON
Ambala
HARYANA |
8053280287
smo.chcbarara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MMDU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Risk of Non communicable disease |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Empowerment program |
Train the ASHA BP monitoring, RBS Monitoring, Screening of Cancer |
| Comparator Agent |
Observation |
Conduct pre test and post regarding Non communicable disease |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
ASHA workers |
|
| ExclusionCriteria |
| Details |
Who are not physical fitness
Who are attended NCD training program |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Enhance the skill and knowledge of ASHA workers regarding NCD screening and management |
AT 4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Community population aware about risk of Non communicable disease |
AT 8 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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="2"
Months="4"
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
|
A quasi experimental study conducted to assess the effectiveness of empowerment program for integrated screening and management of Non Communicable disease in terms of knowledge and skills among ASHA workers of selected community of haryana. Sample will choosen by simple random sampling and using purposive sampling technique. Intervention given to experimental group only and than check the effectiveness of empowerment program through knowledge question and observation checklist regarding BP monitoring, RBS monitoring, Physical examination, BSE, Oral assessment, cervical cancer assessment |