| CTRI Number |
CTRI/2025/09/094726 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [m-Health education] |
| Study Design |
Other |
|
Public Title of Study
|
Effect of nurse-led mHealth education on prevention of UTI in patients with per urethral indwelling urinary catheter visiting urology OPD. |
|
Scientific Title of Study
|
Effect of nurse-led mHealth education on prevention of UTI in patients with per urethral indwelling urinary catheter visiting urology OPD: A quasi experimental study. |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushi |
| Designation |
M.Sc Nursing 1st year student |
| Affiliation |
College of Nursing, AIIMS, Jodhpur |
| Address |
Room no.224, Floor 1st, Old girls hostel no.3, main gate no.6, AIIMS Jodhpur, Heavy Industrial Area, Phase 2, Basni , Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
7988331316 |
| Fax |
|
| Email |
khushibiyani2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nipin Kalal |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, AIIMS, Jodhpur |
| Address |
Room no. 107, Floor 1st , College of Nursing , AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8955945598 |
| Fax |
|
| Email |
kalalnipin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nipin Kalal |
| Designation |
Assistant Professor |
| Affiliation |
College of Nursing, AIIMS, Jodhpur |
| Address |
Room no. 107, Floor 1st , College of Nursing , AIIMS Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8955945598 |
| Fax |
|
| Email |
kalalnipin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self
Room no.224, Floor 1st, Old girls hostel no.3, main gate no.6, AIIMS Jodhpur, Heavy Industrial Area, Phase 2, Basni , Jodhpur
Jodhpur
RAJASTHAN
342005
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [N/A] |
|
|
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 Nipin Kalal |
AIIMS Jodhpur |
ROOM NO. 535 5TH FLOOR UROLOGY OPD.
Jodhpur
RAJASTHAN |
8955945598
kalalnipin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N399||Disorder of urinary system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
m-Health education |
Participants in the control group will be provided with standard routine care. On the other hand, participants in the experimental group will be provided standard routine care and with the following interventions:
1. Health education through mHealth at OPD: In the first step of intervention patients with freshly inserted indwelling urinary catheter will receive health education on how to prevent Urinary Tract Infection (UTI) which will include the like how to maintain catheter hygiene, care of drainage bag, when and how to empty the catheter bag, monitor for signs of infection, hydration and diet.
2. Sharing the video through WhatsApp: The next step of intervention will include sharing the video on prevention of UTI through WhatsApp. Patients can rewatch and clarify doubts as needed.
3. Telephonic Follow up: Third step of intervention will include telephonic follow up on weekly basis to assess adherence to IPC measures. Address patient concerns and reinforce key messages and at last follow up of the patients will be there after one month.
Total duration of intervention is one month.
|
| Comparator Agent |
Standard routine care without m-health education |
The comparator agent is the control group, which receives standard routine care without m-health education |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Patient
1. With the diagnosis of Urethral stricture ,bladder dysfunction BPH.
2. With newly inserted indwelling urinary catheter.
3. Patient or relative having smartphone
4. Who will able to understand Hindi
|
|
| ExclusionCriteria |
| Details |
1. Patient having diagnosis of documented urinary tract infection.
2. Patients undergoing recatheterization.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To develop and evaluate the effectiveness of a nurse-led mHealth education program in improving awareness and preventive practices related to urinary tract infections (UTIs) among patients with per urethral (P/U) indwelling urinary catheters.
|
After one month of enrollment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
15/10/2025 |
| 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 Yet Recruiting |
| 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 tract infection (UTI) is one of the most common complications associated with per urethral (P/U) indwelling urinary catheters, leading to increased morbidity, prolonged hospital stay, and healthcare burden. Patient education on catheter care is a crucial strategy in reducing infection risk, yet traditional methods are often limited by time, accessibility, and recall. Mobile health (mHealth) technology offers an innovative platform to deliver continuous, patient-friendly education. The present quasi-experimental study aims to develop and implement a nurse-led mHealth education program for patients with indwelling urinary catheters attending the Urology OPD. The objectives are: (1) to design and provide structured mHealth education regarding catheter care and infection prevention, and (2) to assess and compare urinary tract infection parameters between experimental and control groups. The study seeks to generate evidence on the effectiveness of nurse-led mHealth education in preventing UTIs, thereby promoting self-care, safety, and better patient outcomes. |