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
|
|
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
|
|
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
|
|
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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