| CTRI Number |
CTRI/2023/08/056560 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
11/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Population based study on anemia amongst nurses |
|
Scientific Title of Study
|
A study to assess the effectiveness of population based screening for anemia on treatment initiation and adherence amongst nurses working in PGIMER, Chandigarh |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharti Devi |
| Designation |
Student |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no. 118, National Institute of Nursing Education
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8708373564 |
| Fax |
|
| Email |
bharti1993kartik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neena Vir Singh |
| Designation |
Associate Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no. 212, National Institute of Nursing Education
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8146552482 |
| Fax |
|
| Email |
neenasingh_2@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Bharti Devi |
| Designation |
Student |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room no. 118, National Institute of Nursing Education
Chandigarh
CHANDIGARH
160012
India |
| Phone |
09555857287 |
| Fax |
|
| Email |
bharti1993kartik@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education, Postgraduate Institute of Nursing Education, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Bharti Devi |
| Address |
Room no. 118, National Institute of Nursing Education, PGIMER, Chandigarh |
| 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 |
| Bharti Devi |
Postgraduate Institute of Medical Education and Research , Chandigarh |
Nehru wing, Department of clinical hematology and medical oncology
Chandigarh
CHANDIGARH |
8708373564
bharti1993kartik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Anemia D64.9 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Protocol booklet on management of anemia |
Protocol on management of anemia on treatment initiation and adherence amongst nurses working in PGIMER, Chandigarh |
| Intervention |
Protocol on management of anemia |
Administration of protocol on management of anemia over 3 months to observe the effectiveness on treatment initiation and adherence amongst nurses working in PGIMER, Chandigarh |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Female nurses working in PGIMER in the reproductive age group |
|
| ExclusionCriteria |
| Details |
Male nurses
Nurses with Pregnancy
Nurses who are lactating
Nurses who are on supplements for more than one month |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Estimation of prevalence of anemia amongst nurses
2.Identification of the factor s associated with anemia amongst nurses
3. Treatment initiation amongst screened nurses
4. Treatment adherence amongst screened nurses
|
after one month of treatment initiation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Hb levels |
after one month |
|
|
Target Sample Size
|
Total Sample Size="410"
Sample Size from India="410"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
21/08/2023 |
| 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="0"
Months="3"
Days="28" |
|
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 study to assess the effectiveness of population - ÂÂÂbased screening for anemia on treatment initiation and adherence amongst nurses working in PGIMER, Chandigarh (2022 -24) - a protocol on management of anemia is developed for those nurses who will be diagnosed to have anemia after screening to motivate them to initiate treatment and improve adherence to treatment which will assist in improvement of Hb levels. |