| CTRI Number |
CTRI/2024/01/061089 [Registered on: 03/01/2024] Trial Registered Prospectively |
| Last Modified On: |
02/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Clinical care pathway |
| Study Design |
Other |
|
Public Title of Study
|
Comparative efficacy of nurse led clinical care pathway with routine care to develop a nursing manual for improvement of quality of nursing care among children with Lower Respiratory Tract Infection. |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of nurse led clinical care pathway with routine care to develop a nursing manual for improvement of quality of nursing care children with Lower Respiratory Tract Infection. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Taksande |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education and Research (Deemed to be University ) |
| Address |
Department Child Health Nursing , Smt.
Radhikabai Meghe Memorial Collage of Nursing , Datta Meghe
Institute of Higher Education &Research (DMIHER) Wardha ,MAHARASHTRA
442001
India
Department Child Health Nursing , Smt.
Radhikabai Meghe Memorial Collage of Nursing , Datta Meghe
Institute of Higher Education &Research (DMIHER) Wardha ,MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
08698471976 |
| Fax |
|
| Email |
aptaksande@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Archana Taksande |
| Designation |
Assistant Professor |
| Affiliation |
S.R.M.M.C.O.N. Datta Meghe Institute Of Higher Education and Research (Deemed to be University ) |
| Address |
SRMMCON, Datta Meghe Institute Of Higher Education and Research (Deemed to be University ),
Sawangi (M),
Wardha.
MAHARASHTRA
442001
Department Child Health Nursing , Smt.
Radhikabai Meghe Memorial Collage of Nursing , Datta Meghe
Institute of Higher Education &Research (DMIHER) Wardha ,MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
08698471976 |
| Fax |
|
| Email |
aptaksande@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Bibin Quarian |
| Designation |
Associate Professor |
| Affiliation |
S.R.M.M.C.O.N. Datta Meghe Institute Of Higher Education and Research (Deemed to be University ) |
| Address |
SRMMCON, Datta Meghe Institute Of Higher Education and Research (Deemed to be University ),
Sawangi (M),
Wardha.
MAHARASHTRA
442001
Department Child Health Nursing , Smt.
Radhikabai Meghe Memorial Collage of Nursing , Datta Meghe
Institute of Higher Education &Research (DMIHER) Wardha ,MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7020156450 |
| Fax |
|
| Email |
bibinkurian546@gmail.com |
|
|
Source of Monetary or Material Support
|
| A.V.B.R.HOSPITAL ,Sawangi meghe wardha |
|
|
Primary Sponsor
|
| Name |
Archana Taksande |
| Address |
Smt. Radhikabai Meghe Meeorial College Of Nursing (DMIHER) |
| Type of Sponsor |
Other [Other [(Research 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 |
| Archana Taksande |
Accharya Vinobha Bhave Rural Hospital, Sawangi Meghe Wardha |
Child Health Nursing Nursing Department, Smt Radhikabai
Meghe Memorial college of Nursing Sawangi Meghe WardhaWardha
MAHARASHTRA
Wardha
MAHARASHTRA |
8698471976
-
aptaksande@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| nstitutional Ethics Committee Datta Meghe Institute of Higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Under five children with Lower Respiratory Tract Infection |
Children outcome- Reduction of hospital stay , early recovery , control complication & improve quality care.parental satisfaction |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Staff nurses who are caring the under five children with lower respiratory tract infection patient. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop and validate clinical care pathway with LRTI children. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop & validate clinical care pathway with LRTI children. |
3 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2024 |
| 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="24"
Months="9"
Days="5" |
|
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
|
This study is a randomized, participant blinde, sealed
opaque envelope, observation trail comparing
innovation: The innovation of the clinical care
pathway has o be helpful in improving the quality care of LRTI under five years
children . |