| CTRI Number |
CTRI/2025/10/096735 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study on how women in Karkala Taluk use and benefit from ASHA workers’ services |
|
Scientific Title of Study
|
Perception and Utilization of ASHA worker services among women in Karkala taluk: A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Ashitha06 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashitha |
| Designation |
Student |
| Affiliation |
Nitte institute of allied health sciences Nitte (Deemed to be University) Mangaluru |
| Address |
Department of public health
Physiotherapy block
Nitte institute of allied health sciences, Mangaluru, Dakshina Kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9535409554 |
| Fax |
|
| Email |
nykashitha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Reni N |
| Designation |
Assistant Professor |
| Affiliation |
Nitte institute of allied health sciences Nitte (Deemed to be University) Mangaluru |
| Address |
Department of public health
Physiotherapy block
Nitte institute of allied health sciences, Mangaluru, Dakshina Kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7306322769 |
| Fax |
|
| Email |
drreni.n@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Reni N |
| Designation |
Assistant Professor |
| Affiliation |
Nitte institute of allied health sciences Nitte (Deemed to be University) Mangaluru |
| Address |
Department of public health
Physiotherapy block
Nitte institute of allied health sciences, Mangaluru, Dakshina Kannada
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7306322769 |
| Fax |
|
| Email |
drreni.n@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte institute of allied health sciences, Mangalore, Karnataka India
Pin - 575018 |
|
|
Primary Sponsor
|
| Name |
Ashitha |
| Address |
Nitte institute of allied health sciences, Mangalore, Karnataka India
Pin - 575018 |
| 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 Reni N |
Karkala Taluk |
Kadthala, Varanga, Marne grama panchayath, Karkala taluk, Udupi Dist karnataka
Pin - 574108
Udupi
KARNATAKA |
09535409554
nykashitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S hegde medical academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal women |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Women residing in the selected villages of Karkala taluk for at least 6 months and belonging to the reproductive age group |
|
| ExclusionCriteria |
| Details |
Women unable to respond due to mental health issues and those unavailable during data collection |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the perception and utilization of services provided by ASHA workers among women of reproductive age (15–49 years) in Karkala Taluk |
Factors influencing the utilization of ASHA worker services among these women assessed with in 4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the level of awareness & satisfaction of women regarding ASHA worker services, & to identify barriers & sociodemographic factors influencing their utilization. |
With Timeline 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="1187"
Sample Size from India="1187"
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)
|
12/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="20" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
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 [nykashitha@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study explores the perception and utilization of ASHA worker services among women aged 15–49 years in Karkala Taluk. ASHAs, introduced under the National Rural Health Mission, act as a bridge between communities and healthcare, especially for women and children. Using a community-based cross-sectional design, the research will include 1187 women selected through systematic random sampling. Data will be collected using a validated questionnaire on awareness, perception, and use of ASHA services, along with influencing factors. The results will help highlight strengths, challenges, and areas for improvement in ASHA service delivery and community health outcomes |