| CTRI Number |
CTRI/2017/03/008109 [Registered on: 15/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
19/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Descriptive Survey Design |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess the practice and perceived barriers towards infection control measures among health care workers (HCWs) in dialysis unit |
|
Scientific Title of Study
|
A study to assess the practice and perceived barriers towards infection control measures among health care workers (HCWs) in dialysis unit of a tertiary hospital, Udupi District, Karnataka. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Jackline Prathibh |
| Designation |
II year MSc Nursing |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Manipal college of Nursing,Manipal University, Madhav Nagar, Saralebettu, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8123380887 |
| Fax |
918202922572 |
| Email |
prathibha.jackline222@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Daisy Josphine Lobo |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Manipal college of Nursing,Manipal University, Madhav Nagar, Saralebettu, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
9535687697 |
| Fax |
918202922572 |
| Email |
daisylobo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Jackline Prathibha |
| Designation |
II year MSc Nursing |
| Affiliation |
Manipal College of Nursing Manipal |
| Address |
Manipal college of Nursing,Manipal University, Madhav Nagar, Saralebettu, Manipal.
Udupi
KARNATAKA
576104
India |
| Phone |
8123380887 |
| Fax |
918202922572 |
| Email |
prathibha.jackline222@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal, Udupi district. |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [] |
|
|
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 |
| Jackline Prathibha |
Dialysis unit, Kasturba Hospital, Manipal |
Dialysis Unit,Department of Nephrology,Tertiary hospital
Udupi
KARNATAKA |
8123380887
prathibha.jackline222@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital, Manipal communication of the decision of the Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Infection control measures among health care workers |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Health care workers who are: working in dialysis unit during data collection period and willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1st year and 2nd year dialysis technician students |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| knowledge of practice, practice and barriers |
For 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "602"
Final Enrollment numbers achieved (India)="602" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2016 |
| Date of Study Completion (India) |
21/06/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published in Medico legal update journal, Jan march 2020 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Aims- assess the knowledge of practice among healthcare workers regarding infection control measures by using a structured knowledge questionnaire.
- assess the practice among health care workers regarding infection control measures using an observation checklist.
- assess the perceived barriers in following the infection control measures using open ended questionnaires.
Sample size All the healthcare workers available during the data collection in the dialysis unit will be included in the study and they will be observed for the infection control measures which they follow while performing the procedures related to dialysis. Detailed description of the process - Data collection on practice of infection control measure in dialysis unit will be done by event sampling. the observation of the events of infection control measures followed by HCWs while caring for the patients undergoing dialysis in dialysis unit of tertiary hospital using validated observational checklist will be done for first two weeks of data collection.
- Informed consent will not be taken for the observation of the procedures as the awareness of been observed, will increase the possibility that the participant may change their behavior.for this purpose i am requesting the waiver of consent.
- After the completion of practice observation , validated knowledge of practice questionnaires and open ended questionnaires on barriers to infection control measures in dialysis unit will be administered to the participants after explaining the participant information sheet and obtaining informed consent.
- The participants who are willing to participate in the study will be asked to fill out the tools.
- while taking consent for the knowledge and barrier questionnaires the participants will be informed about the observation of the procedures which had been observed before. the researcher will justify stating that if the participant was been aware of the observation there is the high possibility that the participant may change their behavior.
- The tools will be collected back on the same day after completing the knowledge questionnaire.
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