| CTRI Number |
CTRI/2018/10/016003 [Registered on: 12/10/2018] Trial Registered Prospectively |
| Last Modified On: |
12/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between knowledge of caregivers of children with acute leukemia recieving video based education regarding prevention of infection during chemotherapy and the ones recieving routine care |
|
Scientific Title of Study
|
A randomized control trial to evaluate the effect of video based education on knowledge of caregivers of children with acute leukemia regarding prevention of infection during chemotherapy at AIIMS, New Delhi |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aanchal |
| Designation |
M.Sc Nursing student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College of nursing ,AIIMS,Ansari Nagar
College of nursing, Ansari Nagar, AIIMS
South
DELHI
110049
India |
| Phone |
8920455490 |
| Fax |
|
| Email |
aanchaltauras@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditi Prashant Sinha |
| Designation |
lecturer |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College of nursing,Ansari Nagar , AIIMS ,New Delhi
college of nursing, Ansai Nagar, AIIMS, New Delhi
New Delhi
DELHI
110049
India |
| Phone |
8920455490 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aanchal |
| Designation |
M.Sc Nursing student |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
College Of Nursing,Ansari Nagar, AIIMS, New Delhi
College Of Nursing,Ansari Nagar, AIIMS, New Delhi
New Delhi
DELHI
110049
India |
| Phone |
8920455490 |
| Fax |
|
| Email |
aanchaltauras@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aanchal |
| Address |
N 307, Medha hostel, Masjid Moth, AIIMS, New Delhi |
| 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 |
| Aanchal |
AIIMS, New Delhi |
C5 (Pediatric) Daycare , 5th floor,Main Building, AIIMS
New Delhi
DELHI |
8920455490
aanchaltauras@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee of AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of children with acute leukemia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care |
As per inclusion and exclusion criteria participants will be enrolled with their consent and a pre-test will be taken, all participants will be given routine care (includes verbal education by the health personnel and provision of written materials) concealed envelope will be opened to allocate the participant into control or experimental group
Control group participant will be asked to fill a post-test immediately after and at 1 month of the routine care
A telephonic assessment is done for all participants at 15th day of enrollment
|
| Intervention |
Video based education |
Experimental group participants will receive Video based education only once which will be displayed for 13 minutes consisting of ways to prevent infection and maintain a healthy lifestyle in children with acute leukemia undergoing chemotherapy after routine care and a post test immediately and at 1 month will be obtained, they will be asked to fill video evaluation form |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Caregiver having age ≥ 18 years
2.Caregiver of a child with acute leukemia
undergoing chemotherapy cycle 1 and 2.
3.Caregiver who is able to understand
Hindi/English language.
4.Caregivers whose hearing and vision is
corrected/not impaired
5.Caregiver who have been living with the child
for a period of minimum 1 month and who are
available for the study.
|
|
| ExclusionCriteria |
| Details |
1.Privately hired caregivers
2.Caregivers who do not give consent for the
study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There will be a significant difference in the knowledge of caregivers of children with acute leukemia who will receive VBE in addition to routine care as compare to those who will receive only routine care regarding prevention of infection during chemotherapy. |
3 Times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There is an association between the knowledge of caregivers of children with acute leukemia regarding prevention of infection during chemotherapy and selected demographic variables. |
3 times, pretest, immediate post test and at 1 month of the intervention |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 1 |
|
Date of First Enrollment (India)
|
15/10/2018 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
This will be provided on completion of this study, at present researcher doesnt have information about publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose: Preparing the caregivers of cancer patients for chemotherapy treatment
is difficult. The challenge lies in finding ways to promote self-care and
improve the ability to recall instructions. Even with the periodic counselling
and teaching provided in relation to healthy habits and danger signs, the
incidence of febrile neutropenia is increasing in children with acute leukemia. So there is a need to formulate and evaluate the effectiveness of a method,
which is easy to implement and have good outcomes that will help to improve the
way, routine health education is being provided. Video will be easily
accessible with technological advancements and can be referred as many times
one wishes and thereby, help in brushing up of the information. Background and results: As it is an new intervention and a self developed video so the results can only be stated at completion of the study. |