| CTRI Number |
CTRI/2024/04/065683 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Urinary Catheter Care Package (UCCP) |
|
Scientific Title of Study
|
A Randomised controlled trial to assess the effectiveness of Urinary Catheter Care Package (UCCP) on catheter care practices among caregivers and quality of life among patients with long term indwelling urinary catheter attending Urology units, PGIMER, Chandigarh, 2023-24. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran |
| Designation |
Post basic student |
| Affiliation |
National Institute of Nursing Education, PGIMER Chandigarh |
| Address |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8544762767 |
| Fax |
|
| Email |
simranchauhan631@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashok Kumar |
| Designation |
Nursing Tutor |
| Affiliation |
National Institute of Nursing Education, PGIMER , Chandigarh |
| Address |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855012233 |
| Fax |
|
| Email |
ajangir_27@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Ashok Kumar |
| Designation |
Nursing Tutor |
| Affiliation |
National Institute of Nursing Education , PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research,Chandigarh,160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855012233 |
| Fax |
|
| Email |
ajangir_27@yahoo.in |
|
|
Source of Monetary or Material Support
|
| National Institute of Nursing Education,PGIMER,Chandigarh, 160012, INDIA |
|
|
Primary Sponsor
|
| Name |
Simran |
| Address |
National Institute of Nursing Education,Post Graduate Institute of Medical Education and Research,Chandigarh,160012 |
| 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 |
| Dr Ashok Kumar |
Hospital based trial |
Urology units, PGIMER,Chandigarh
160012, INDIA
Chandigarh
CHANDIGARH |
9855012233
ajangir_27@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE of NINE, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Routine care for patients with long term indwelling urinary catheter for 10 days |
| Intervention |
Urinary Catheter Care Package (UCCP) |
Urinary Catheter Care Package
which includes 4 components:
Hand hygiene,Cleaning of skin
and catheter care, Handling of bag, Quality of Life for 10 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patient and their caregivers who will give informed written consent and willing to participate in study. |
|
| ExclusionCriteria |
| Details |
Patient having suprapubic catheter. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Point Prevalence of Catheter Associated urinary tract infection (CAUTI) among patients with long term indwelling urinary catheter.
•Practices of caregivers of patient’s with long term indwelling urinary catheter.
•Quality of life among patients with long term indwelling urinary catheter (measured by ICIQ-LTCqol score)
|
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve quality of life of patient with long term indwelling urinary catheter |
1month |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| 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="0"
Days="1" |
|
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
|
Urinary Catheter Care Package (UCCP) is a protocol that uses, in the patients with indwelling urinary catheter, to reduce the risk of Catheter Associated Urinary Tract Infection (CAUTI) and improve the health status of the patients and maintain the quality of life among patients. Urinary catheter care package:- It include observation, assessment and provide urinary catheter care educational package including hand hygiene technique, Cleaning and handling technique, emptying of urinary bag, positioning of urinary bag and ways to improve quality of life of patients |