| CTRI Number |
CTRI/2018/12/016587 [Registered on: 10/12/2018] Trial Registered Prospectively |
| Last Modified On: |
07/12/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study to develop and test a program for the caregivers of patients with head injury |
|
Scientific Title of Study
|
Development and testing of a caregiver education program for patients with Traumatic Brain Injury |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ajinkya Nitin Patwardhan |
| Designation |
Post Graduate Student |
| Affiliation |
School of Allied Health Sciences, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9763440969 |
| Fax |
|
| Email |
anppatwardhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr John Solomon M |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945670671 |
| Fax |
|
| Email |
john.solomon@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Manikandan |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences, Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886898064 |
| Fax |
|
| Email |
mani.kandan@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
School of Allied health Sciences |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [Private Allied Health College] |
|
|
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 |
| Ajinkya Patwardhan |
Kasturba Hospital |
Third floor, Neurosurgery ward, Dhanvantri block
Udupi
KARNATAKA |
9763440969
anppatwardhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S098||Other specified injuries of head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Caregiver Education Program |
The caregiver education program is a program for the caregivers of patients having head injury. It consists of different components about the care and precautions which the caregivers would need to take for the patient after discharge. It will also consist of few exercises which the caregivers need to give to the patient after discharge |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for Patients:
Patients suffering from moderate to severe head injury
Inclusion criteria for caregivers:
1)Individuals with age more than 18 years
2)Individuals who are primary caretakers
3)Individuals who will be able to understand and follow the instructions by the investigator
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria for patients:
Patients with no designated caregiver, those who are medically unstable and those discharging against medical advice
Exclusion criteria for caregivers:
Individuals with mental disorders, those having any disability or chronic pain that affect their caretaking and those with known medical illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Disability Rating Scale |
Before the discharge of the patient and after one month at the time of follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Caregiver burden scale |
Before the discharge of the patient and after one month at the time of follow-up |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
14/12/2018 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an interventional pilot study. The main aim of the study is to test the feasibility and the role of a caregiver education program for patients who have sustained traumatic brain injury. The caregiver education program was developed using the delphi method of consensus. The program consists of components such as passive movements, stretching, coma stimulation, transferring the patient, positioning the patient, feeding etc. The caregivers of the patients will be educated through the program three days before the discharge of the patient and their knowledge about the same will be verified on the day of discharge. The Disability Rating Scale and Caregiver Burden Scale will be administered on the day of discharge. The caregivers will be advised to give the exercises to the patients and take the necessary precautions as mentioned in the program after discharge for one month. After one month at the time of follow-up the Disability Rating Scale and Caregiver Burden Scale will be administered again and the pre and post values of the same will be compared. The results obtained will be recorded, analysed and tabulated to test the benefits of the program. |