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CTRI Number  CTRI/2020/04/024546 [Registered on: 09/04/2020] Trial Registered Prospectively
Last Modified On: 08/04/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Teaching program on selected non communicable diseases risk reduction]  
Study Design  Single Arm Study 
Public Title of Study   Effect of structured training program on selected non communicable diseases risk reduction among women on knowledge and skills of female health workers 
Scientific Title of Study   A study to assess effectiveness of structured training programme on selected non communicable diseases risk reduction among women on knowledge and selected performance outcome of female health workers 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mamta 
Designation  Lecturer 
Affiliation  College of Nursing, All India Institute of Medical Sciences, Jodhpur 
Address  College of Nursing All India Institute of Medical Sciences Basni Phase II

Jodhpur
RAJASTHAN
342005
India 
Phone  9680580088  
Fax    
Email  mamta_rajput45@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sushma K Saini 
Designation  Lecturer 
Affiliation  National Institute of Nursing Education  
Address  National Institute of Nursing Education PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9888038248  
Fax    
Email  sushmadr_saini@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Mamta 
Designation  Lecturer 
Affiliation  College of Nursing, All India Institute of Medical Sciences, Jodhpur 
Address  College of Nursing All India Institute of Medical Sciences Basni Phase II

Jodhpur
RAJASTHAN
342005
India 
Phone  9680580088  
Fax    
Email  mamta_rajput45@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Self funded 
Address  Mamta Lecturer College of Nursing AIIMS Jodhpur 
Type of Sponsor  Other [Self managed by prinicpal Investigator. No financial source or sponsor] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mamta  Health centres within 20 kilometer radius of AIIMS Jodhpur  Health centres within 20 kilometer radius of AIIMS Jodhpur
Jodhpur
RAJASTHAN 
9680580088

mamta_rajput45@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Female Health Workers working at selected health centres of Jodhpur. Women being rendered selected NCDs health services by these health workers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  Single arm one group pretest posttest 
Intervention  Structured training programme on selected non communicable diseases risk reduction  Female health workers working at selected health centres of Jodhpur city will be enrolled in the study and baseline knowledge assessment related to selected NCDs which are more prevalent among women i.e. Hypertension, Diabetes, Breast cancer, cervical cancer and poor mental health will be done. Knowledge will be assessed with help of self structured knowledge questionnaire. Baseline performance outcome in terms of skill measurement related to BP, Blood glucose monitoring, Breast examination skills, Waist circumference, Height and weight measurement will be assessed using skill checklist. The records maintained by the FHWs will be analysed for last 1 week NCD service delivery for selected NCDs to women. Thereafter Structured training programme on selected non communicable diseases risk reduction among women will be delivered to Female health workers. The content will include introduction and burden of selected NCDs (Hypertension, Diabetes, Breast and Cervical Cancer and poor mental health), Health promotion & Prevention strategies (Prevention & control of High Blood pressure, Diabetes, Breast & cervix cancer), Guide to screening with help of simple screening tools (steps & cut off points), Referral and myths related to selected NCDs. Training will be imparted via lectures and practical skill demonstration. The post training knowledge levels, skills and record analysis will be assessed at 1 week and 3 months after training.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  For Study Setting: All the health centres (Satellite centres, Civil dispensaries, primary health centres and Sub centres) falling within 20 kilometre radius from AIIMS, Jodhpur.

For Subjects:
a. Female health worker willing to participate in the study.
b. Female health worker available at time of data collection.
c. Women willing to participate in the study.
d. Women available at the time of data collection.
e. Women coming to health centre and given NCDs risk reduction services by FHWs.
f. Women able to understand or read and write Hindi.
 
 
ExclusionCriteria 
Details  If any health center is found not to have any female health care worker, that center will be excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in knowledge levels and skills of female health workers regarding selected non communicable diseases risk reduction among women.
Women satisfaction (clients) regarding NCDs risk reduction services rendered by FHWs.  
Baseline, 1 week and 3 months post training 
 
Secondary Outcome  
Outcome  TimePoints 
Association of knowledge levels, skill levels of FHWs with selected socio-demographic characteristics.
 
Baseline, 1 week and 3 months post training 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   11/04/2020 
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   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

NCDs represent the biggest threat to women’s health worldwide, increasingly impacting on women in developing countries in their most productive years. Women because of their gender, social responsibilities, family role, internalization of feelings are more prone to become prey to non-communicable diseases. Moreover, health care research into gender disparities in the development and treatment of NCDs is sparse.

Female health workers being the most important cadre of health care system provide services to diverse groups. They directly relate to masses and act as a link between the primary and higher health care settings. As they increasingly play a more prominent role in providing health services, there is an increasing need to ensure that they possess the necessary knowledge and competencies to satisfactorily perform their expanding roles. Effective training of health care workers in new topics and skills, ensures that health workers have the capacity to provide quality health education and services.

Research on the performance of female health works remains quite limited and there is paucity of data.  Till date very few research studies has been carried out globally and at national level related to measurement of performance outcome of female health worker in terms of NCDs risk reduction programme. With this view in mind the current study is being planned to train female health workers on the said topic. The FHWs will be enrolled and assessed for the knowledge, skills and NCD service delivery with help of self-structured tools. Training will be imparted to health workers and 1 week and 3 months post training again post-test will be conducted. the findings of current study will help to update the knowledge of female health workers and expand their work horizon, empower them to take right decisions. On the bigger front which will further help to control and manage the selected NCDs epidemic to some extent.

 
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