| CTRI Number |
CTRI/2022/12/047887 [Registered on: 05/12/2022] Trial Registered Prospectively |
| Last Modified On: |
28/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Educational] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Knowledge about PICC line home care and practices adopted at home to care for PICCs: A Pre Experimental study. |
|
Scientific Title of Study
|
A study to assess the effectiveness of an information booklet on PICC line home care in patients discharged with PICC in terms of knowledge and practice at BRAIRCH, AIIMS New Delhi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Gautam |
| Designation |
M.sc Nursing |
| Affiliation |
College of nursing, AIIMS, New Delhi |
| Address |
Department of Oncology Nursing, College Of Nursing All India Institute Of Medical Sciences, New Delhi
South West
DELHI
110029
India |
| Phone |
8368336808 |
| Fax |
|
| Email |
gautamaditik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Prashant Sinha |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing, AIIMS, New Delhi |
| Address |
Porta Cabin, Department of Oncology Nursing, College of Nursing, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9810784806 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi Prashant Sinha |
| Designation |
Associate Professor |
| Affiliation |
College of Nursing, AIIMS, New Delhi |
| Address |
Porta Cabin, Department of Oncology Nursing, College of Nursing, AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
9810784806 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
College of Nursing, AIIMS, New Delhi, 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Aditi Gautam |
All India Institute of Medical Sciences, New Delhi |
Dr. B.R.A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi OPD room number 15 and day care
South
DELHI |
8368336808
gautamaditik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICAL COMMITTEE FOR POAT GRADUATE RESEARCH ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Information booklet |
information booklet on PICC line home care which will include the introduction, definition of PICC, indications of PICC, general knowledge regarding PICC, care of PICC line at home and complications of PICC line |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with oncological disease who are receiving treatment at BRAIRCH AIIMS, New Delhi
2. Patients discharged with PICC line
3. Patients who will be able to understand Hindi / English language.
4. Patients who are willing to participate in the research.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are not willing to participate in the study.
2. Patients who could not comprehend or respond to the questionnaire in Hindi or English.
3. Patients having known psychiatric illness prior to diagnosis.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of an information booklet on knowledge and practice
regarding PICC line home care in patients discharged with PICC line |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare pre-test and post-test knowledge and practice regarding PICC line home care in patients discharged with PICC line.
2. To seek association of pre-test knowledge and practice with selected demographic variables
3. To find out the co-relation between knowledge and practice score regarding PICC line home care in patients discharged with PICC line
|
7 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
08/12/2022 |
| 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
|
will publish after the result |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of the study
1. to see effectiveness of information booklet on knowledge and practice of PICC line home care. 2. to assess the level of knowledge and practices adopted by the patients discharged with PICC line towards PICC line home care.
Primary objectives
1. to assess the pre test and post test knowledge and practice regarding PICC line home care 2. to evaluate the effectiveness of an information booklet on knowledge regarding PICC line home care 3. to evaluate the effectiveness of an information booklet on practice regarding PICC line home care
Secondary objectives
1. to compare pre and post test knowledge and practice regarding PICC line home care 2. to seek association of pre test knowledge and practice with selected demographic variables 3. to find out the correlation between knowledge and practice scores regarding PICC line home care
Hypothesis
1. there will be significant difference between pre and post test knowledge scores regarding PICC line home care as measured by a structured questionnaire at 0.05 level of significance 2. there will be significant difference between pre and post test practice scores regarding PICC line home care as measured by a self reported practice questionnaire at 0.05 level of significance |