| CTRI Number |
CTRI/2024/10/074569 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Process of Care Changes
Behavioral |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Nurse-led symptomatic management for children waiting for corrective intervention for congenital heart disease |
|
Scientific Title of Study
|
An experimental study to assess the effectiveness of Nurse-led Care Package for the caregivers of children waiting for corrective interventions for congenital heart disease on selected outcomes a ACC,PGIMER, Chandigarh in 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 |
Niharika Jana |
| Designation |
MSc. Nursing student |
| Affiliation |
National Institute of Nursing Education, PGIMER Chandigarh |
| Address |
MSc. Nursing (Medical-Surgical Nursing- Cardio-thoracic and vascular nursing), National Institute of Nursing Education, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9304046602 |
| Fax |
|
| Email |
njana1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms. Shruti |
| Designation |
Associate professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Room no.-135, NINE, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8437748011 |
| Fax |
|
| Email |
shrutipgi2011@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Niharika Jana |
| Designation |
MSc. Nursing student |
| Affiliation |
PGIMER, Chandigarh |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9304046602 |
| Fax |
|
| Email |
njana1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| CTVS-B, PGIMER, Chandigarh, Chandigarh- 160012, India |
|
|
Primary Sponsor
|
| Name |
Niharika Jana |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh, Chandigarh- 160012 |
| 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 |
| Ms Shruti |
PGIMER Chandigarh |
Room no.- 1015, CTVS OPD, room no.- 1027, Cardio OPD and CTVS- B ward, Advanced Cardiac Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH |
8437748011
shrutipgi2011@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q209||Congenital malformation of cardiacchambers and connections, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Routine care and management |
| Intervention |
Nurse-led care package |
1. Nutrition management
2. Medication adherence
3. Exercise adherence
4. Tet spell management
5. Caregivers stress management
6. Prevention of infection and complications
7. Hemodynamic management
Duration of follow-up- 2 weeks
Study duration- 2 months |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children from birth to 15 yrs. of age and their caregivers who are waiting for their corrective intervention for congenital heart disease,
children suffering with ASD, VSD and TOF |
|
| ExclusionCriteria |
| Details |
Children coming in emergency department, children atleast admitted for 2 weeks (if, admitted) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To develop and implement "Nurse-led care package" for the caregivers of children waiting for corrective interventions of congenital heart disease in ACC, PGIMER, Chandigarh in 2023-25
2. To evaluate the effectiveness of "Nurse-led care package" for caregivers of children waiting for corrective intervention of congenital heart disease on selected outcomes at ACC, PGIMER, Chandigarh in 2023- 25 |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nutritional management
Adherence to exercise regimen
Sleep management
Medication adherence
Management of caregivers stress & anxiety
Improvement in knowledge level of caregiver |
2 months |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
09/10/2024 |
| 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="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
|
This study is an experimental study to identify the effectiveness of "Nurse-led care package" for providing symptomatic management to children waiting for corrective intervention of congenital heart disease with the help of their caregivers as here children are taken into consideration. |