| CTRI Number |
CTRI/2024/06/069316 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [self care package for patients with LGBS and their caregivers] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A study to assess the effectiveness of self care package for patients with Landry Guillain barre syndrome and their caregiverson selected outcome variables attending neurology units, PGIMER, Chandigarh, 2023-25 |
|
Scientific Title of Study
|
A Quasi experimental study to assess the effectiveness of self care package for patients with Landry Guillain barre syndrome and their caregivers on selected outcome variables attending neurology units PGIMER Chandigarh 2023-25 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Itika Dhyani |
| Designation |
MSc nursing student |
| Affiliation |
NINE, Post graduate institute of medical education and research, Chandigarh |
| Address |
Department of medical surgical nursing , Room No 208 ,NINE, Post graduate institute of medical education and research, Sec 12, chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9412947392 |
| Fax |
|
| Email |
itikadhyani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neena vir singh |
| Designation |
Associate professor, Department of nursing |
| Affiliation |
NINE, Post graduate institute of medical education and research, Chandigarh |
| Address |
NINE, Post Graduate Institute of Medical Education and Research Sec 12, chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9412947392 |
| Fax |
|
| Email |
neenasingh_2@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Itika Dhyani |
| Designation |
MSc nursing student |
| Affiliation |
NINE, Post graduate institute of medical education and research,, Chandigarh |
| Address |
Department of Medical surgical nursing , room no. 208, NINE, Post graduate institute of medical education and research, Sec 12, chandigarh, India
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9412947392 |
| Fax |
|
| Email |
itikadhyani@gmail.com |
|
|
Source of Monetary or Material Support
|
| NINE,PGIMER, Sector 12 Chandigarh, 160012 |
|
|
Primary Sponsor
|
| Name |
Itika Dhyani Self |
| Address |
NINE PGIMER Sector 12 Chandigarh |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| Itika Dhyani |
Post graduate institute of medical education and research, Chandigarh |
Neurology and emergency units Post graduate institute of medical education and research, Chandigarh
Chandigarh
CHANDIGARH |
9412947392
itikadhyani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G36||Other acute disseminated demyelination, (2) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, (3) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care of patients |
Routine care involves monitoring vitals, medication administration and all need-based care and monitoring |
| Intervention |
self care package |
self-care package for patients with LGBS and their caregivers on activities of daily living, muscle strength, pressure ulcers, and dysphagia. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 12 years old
Patients and caregivers willing to participate in the study
Understands Hindi Punjabi and English |
|
| ExclusionCriteria |
| Details |
Patients below 12 years old
Patients and caregivers not willing to participate in the study
do not Understands Hindi Punjabi and English |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Activities of daily living
Disability
Pressure ulcer
Pain
Dysphagia |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| disability |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/07/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
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
|
There is a need to develop a self-care package for patients and caregivers since there are issues with the prevention of the severity of complications among patients with LGBS and a knowledge gap. Better patient outcomes should be achieved by emphasizing educating patients and caregivers. Therefore, the current study aims to evaluate the impact of a few chosen outcome factors of the "Self-care package for patients with Landry-Guillain-Barre Syndrome and their caregivers" at the Neurology units of PGIMER, Chandigarh Null hypothesis There will not be any significant impact of Self care package for patients with Landry-Guillain-Barre Syndrome and their caregivers at 0.05 level of significanceAlternative hypothesis There will be significant impact of Self care package for patients with Landry-Guillain-Barre Syndrome and their caregivers at 0.05 level of significance |