| CTRI Number |
CTRI/2025/02/080940 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pressure ulcer prevention by empowering caregivers |
|
Scientific Title of Study
|
Evaluating the Impact of an educational package on Knowledge and practices for prevention of pressure ulcer among caregivers of High risk population at a Tertiary care centre in Andhrapradesh |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRIYA M |
| Designation |
Nursing Tutor |
| Affiliation |
College of Nursing, AIIMS, MANGALAGIRI |
| Address |
College of Nursing, Room no 104
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9990624306 |
| Fax |
|
| Email |
winpriya6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRIYA M |
| Designation |
Nursing Tutor |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
college of Nursing, AIIMS, Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9990624306 |
| Fax |
|
| Email |
winpriya6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRIYA M |
| Designation |
NURSING TUTOR |
| Affiliation |
AIIMS, Mangalagiri |
| Address |
college of Nursing
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9990624306 |
| Fax |
|
| Email |
winpriya6@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS, Mangalagiri, Guntur District, Andhrapradesh.-522503 |
|
|
Primary Sponsor
|
| Name |
Priya M |
| Address |
college of Nursing, AIIMS, Mangalagiri, Guntur District, Andhrapradesh-522503 |
| 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 |
| PRIYA M |
AIIMS, MANGALAGIRI, |
Room no 108, college of Nursing, AIIMS, Mangalagiri, Guntur District, Andhrapradesh
Guntur
ANDHRA PRADESH |
9990624306
winpriya6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, MANGALAGIRI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
standard care |
The standard care includes providing air mattress, positiong to the high risk patient, those who are risk to develop pressure ulcer. |
| Intervention |
Educational package includes Hands on training on skin care , back massage, positioning techniques. |
Educational package includes Hands on training on skin care , back massage will be given to the patient care givers those who are having Highrisk patient is prone to get pressure ulcer. Total duration is 30 minutes teaching on first day after enrollment and reinforcement will be giving daily. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Those who are studies more than 10th,
Those who are close relatives of patients, |
|
| ExclusionCriteria |
| Details |
patient
Those who are not willing to participate
Care giver
Those who are age more than 60 and less than 18
Those who are not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| knowledge, practice level of care givers will be improved more than 30% |
six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease 10% incident rate of pressure ulcer pressure ulcer |
six months |
|
|
Target Sample Size
|
Total Sample Size="268"
Sample Size from India="268"
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)
|
23/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
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
|
In recent years, there has been growing interest in exploring innovative approaches to pressure ulcer prevention, including caregiver involvement in the care process. This study aims to address this gap in the literature by evaluating the effectiveness of a caregiver package on pressure ulcer prevention among high-risk patients at a tertiary care centre. The care package tailored to the unique needs of high-risk populations may include components such as education of pressure ulcer risk factors and prevention strategies, hands-on training in repositioning techniques and skin care, and ongoing support and guidance. |