| CTRI Number |
CTRI/2020/07/026456 [Registered on: 09/07/2020] Trial Registered Prospectively |
| Last Modified On: |
19/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study for effectiveness of nurse led protocol for acceptability of poor prognosis of patients by their caregivers |
|
Scientific Title of Study
|
A Randomized Control Trial on the effectiveness of Nurse-Led Intervention Program on acceptability of poor prognosis among the caregivers of the patients admitted in Intensive and Emergency settings in Nehru Hospital, PGIMER, Chandigarh 2019-21. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Shokeen |
| Designation |
M.Sc Nursing Student |
| Affiliation |
National Institute Of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no 208, Department of Nursing, National Institute Of Nursing Education, PGIMER, Chandigarh, Sector 12
Room no 208, Department of Nursing, National Institute Of Nursing Education, PGIMER, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8249083701 |
| Fax |
|
| Email |
riddhimashokeen6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhpal Kaur |
| Designation |
Lecturer |
| Affiliation |
National Institute Of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no 208, department of Nursing,National Institute Of Nursing Education, PGIMER, Chandigarh, Sector 12
Room no 208, department of Nursing, National Institute Of Nursing Education, PGIMER, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888536964 |
| Fax |
|
| Email |
drsukhpalkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukhpal Kaur |
| Designation |
Lecturer |
| Affiliation |
National Institute Of Nursing Education, PGIMER, Chandigarh |
| Address |
Room no 208, Department of Nursing, National Institute Of Nursing Education, PGIMER, Chandigarh, Sector 12
Room no 208, Department of Nursing, National Institute Of Nursing Education, PGIMER, Chandigarh, Sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9888536964 |
| Fax |
|
| Email |
drsukhpalkaur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 208, Department of Nursing,National Institute of Nursing Education, PGIMER, Chandigarh |
|
|
Primary Sponsor
|
| Name |
National Institute of Nursing Education PGIMER Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh, Sector 12, pin code160012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PGIMER Chandigarh |
Postgraduate Institute of Medical Education and Research, Chandigarh, Sector 12, pin code 160012 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pooja Shokeen |
Nehru hospital, PGIMER, Chandigarh, sector 12 |
Department of Intensive care units, 2nd floor, Nehru Hospital, PGIMER, Chandigarh, Sector 12,Pincode 160012
Chandigarh
CHANDIGARH |
8249083701
riddhimashokeen6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y998||Other external cause status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nurse-Led Intervention Program |
In this Nurse- Led Intervention Program first Screening for poor prognosis of the admitted patients and then counseling for acceptance of poor prognosis to the caregivers |
| Comparator Agent |
Routine care |
Routine care |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1Caregivers of the patients with poor prognosis in intensive &emergency settings , Nehru Hospital ,PGIMER ,CHD
2Caregivers willing to participate. |
|
| ExclusionCriteria |
| Details |
Caregiver having some mental Illness . |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Independent variable: The independent variable in this study is Nurse – led intervention program for the caregivers of the patients with poor prognosis.
Dependent variable: The dependent variable in this study are acceptability of poor prognosis among the caregivers.
|
8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This Nurse- Led Intervention Program will lead in acceptance of poor prognosis by caregivers in future |
1 year |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
16/07/2020 |
| Date of Study Completion (India) |
30/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study administration of Nurse-Led Intervention Program will help in the acceptance of poor prognosis of the patients among the caregivers admitted in critical settings. Nurse counselor will help caregivers in better adjustment with the situation and able to accept the poor prognosis and can cope with the situations in future. |