| CTRI Number |
CTRI/2021/07/034686 [Registered on: 08/07/2021] Trial Registered Prospectively |
| Last Modified On: |
06/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Screening |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A study to assess the effectiveness of video booklet on knowledge attitude and lifestyle practice of nurses |
|
Scientific Title of Study
|
A Randomized control trial to assess the effectiveness of video booklet assisted teaching on NCD prevention related knowledge, attitude, lifestyle practices and biophysical/biochemical parameters among nurses working in various units of selected government hospitals of Chandigarh (2020-21). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumanpreet kaur |
| Designation |
student |
| Affiliation |
Pgimer |
| Address |
Room no 208 National Institute of Nursing Educaion ,PGIMER,Chandigarh
Room no 208 National Institute of Nursing Educaion ,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6280945373 |
| Fax |
|
| Email |
sumanbrar722@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumanpreet kaur |
| Designation |
student |
| Affiliation |
Pgimer |
| Address |
Room no 208 National Institute of Nursing Educaion ,PGIMER,Chandigarh
Room no 208 National Institute of Nursing Educaion ,PGIMER,Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6280945373 |
| Fax |
|
| Email |
sumanbrar722@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrManju Dhandapani |
| Designation |
Lecturer |
| Affiliation |
Pgimer |
| Address |
Room NO 307 National Institute of Nursing Education PGIMER CHANDIGARH
Room no 307 National Institute of Nursing Education PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855151528 |
| Fax |
|
| Email |
manjuseban@gmail.com |
|
|
Source of Monetary or Material Support
|
| Biochemistry department PGIMER Chandigarh |
|
|
Primary Sponsor
|
| Name |
National Institute of nursing education PGIMER Sec Chandigarh |
| Address |
National Institute of nursing education PGIMER Sec 12 Chandigarh |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Jyoti |
Goverment medical college and hospital 32 CHD |
Nursing department,Sector 32 Chandigarh
Chandigarh
CHANDIGARH |
8699940509
collegeofnursinggmch@gmail.com |
| Manjeet Singh |
Government superspeciality hospital |
Nursing Department,GMSH,sector 16 chandigarh
Chandigarh
CHANDIGARH |
9814104609
manjeetsinghtrehan@gmail.com |
| Manju Dhandapani |
PGIMER |
Nehru hospital,PGIMER,CHHD
Chandigarh
CHANDIGARH |
9855151528
manjuseban@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| GMCH 32 |
Submittted/Under Review |
| GMSH -16 CHD |
Submittted/Under Review |
| IEC PGIMER CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nurses |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
video booklet teaching |
vedio booklet teaching on diet,physical activity,stressprevention.alcohol and tobacco prevention will be given for 3 months to intervention group only |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
only female nurses working in various units of selected Govt Hospitals of Chandigarh |
|
| ExclusionCriteria |
| Details |
nurses not available during data collection period and nurses diagnosed with NCD |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in knowledge,attitude and practice of nurses related to NCD prevention |
After 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in biophysical and biochemical parameters of nurses |
change in paraeters after 3 months |
|
|
Target Sample Size
|
Total Sample Size="308"
Sample Size from India="308"
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 2 |
|
Date of First Enrollment (India)
|
15/07/2021 |
| 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
|
findings of the study will be published after completion of study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is randomized control trial to assess the effectiveness of video booklet-assisted teaching on NCD prevention-related knowledge, attitude and lifestyle practices , biophysical and biochemical parameters among nurses working in various units of selected government hospitals of Chandigarh. Participants will be recruited from july 2021, preassessment of knowledge,attitude,lifestyle practices ,biophysical and biochemical parameters will be done.Video booklet teaching will be provided ...post assessment of all the parameters will be done after 3 months.. |