| CTRI Number |
CTRI/2024/02/062333 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [video assisted teaching] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
video-assisted teaching programme on anticoagulant drug therapy for post operative mechanical heart valve patients. |
|
Scientific Title of Study
|
A study to assess the effectiveness of video-assisted teaching programme on knowledge regarding anticoagulant drug therapy among postoperative patients with mechanical heart valve in AIIMS, Bhopal. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aityhang Subba |
| Designation |
MSc. Nursing |
| Affiliation |
AIIMS Bhopal |
| Address |
MSc. Nursing, Nursing college,
All India Institute of medical sciences bhopal
All India Institute of Medical Sciences, Saket Nagar Bhopal, MP,India
Bhopal
MADHYA PRADESH
462020
India |
| Phone |
07004600751 |
| Fax |
|
| Email |
aityhangs.mscnursing22@aiimsbhopal.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Aityhang Subba |
| Designation |
MSc. Nursing |
| Affiliation |
AIIMS Bhopal |
| Address |
MSc. Nursing, Nursing college,
All India Institute of medical sciences bhopal
All India Institute of Medical Sciences, Saket Nagar Bhopal, MP,India
MADHYA PRADESH
462020
India |
| Phone |
07004600751 |
| Fax |
|
| Email |
aityhangs.mscnursing22@aiimsbhopal.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Aityhang Subba |
| Designation |
MSc. Nursing |
| Affiliation |
AIIMS Bhopal |
| Address |
MSc. Nursing, Nursing college,
All India Institute of medical sciences bhopal
All India Institute of Medical Sciences, Saket Nagar Bhopal, MP,India
MADHYA PRADESH
462020
India |
| Phone |
07004600751 |
| Fax |
|
| Email |
aityhangs.mscnursing22@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| Nursing College, AIIMS Bhopal |
|
|
Primary Sponsor
|
| Name |
Aityhang Subba |
| Address |
MSc. Nursing, Nursing college,
All India Institute of Medical Sciences, Saket Nagar Bhopal, MP,India |
| 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 |
| Dr Anurag Bhai Patidar |
All India Institute of Medical Sciences, Bhopal |
Department of Cardiothoracic and Vascular Surgery, All India Institute of Medical Sciences, Saket Nagar, Bhopal, MP,462020 Bhopal MADHYA PRADESH
Bhopal
MADHYA PRADESH |
7898105551
anurag.nursing@aiimsbhopal.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Student Research (IHEC-SR), AIIMS Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, (2) ICD-10 Condition: I058||Other rheumatic mitral valve diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
video-assisted teaching program will not be given to control group |
| Intervention |
Video assisted teaching programme |
it will be a video of 15-20 min about anticoagulant drug therapy prepared by the researcher with consultation form subject experts. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with mechanical heart valve on anticoagulant therapy admitted postoperatively in CTVS ward and CTVS ICU AIIMS Bhopal.
Patients who understand and communicate in Hindi and English.
Patients who are above the age of 15 years old. |
|
| ExclusionCriteria |
| Details |
Patients who are not available at the time of data collection.
Patients who are critically ill and are not hemodynamically stable.
Patients who cannot understand and communicate in Hindi and English |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in pretest and post test knowledge regarding anticoagulant drug therapy |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| knowledge score on anticoagulant drug therapy among post operative patients with the mechanical heart valve at 0.05 level of significance. |
3rd, 4th and 5th post operative day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
14/02/2024 |
| 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="4"
Days="0" |
|
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
|
·
Anticoagulants are widely used to
prevent and treat thromboembolic events but are also high-risk
medications. They are associated with increased risk of bleeding and are
one of the top drugs causing emergency room. It has been shown that
patients forget about 80% of what they learn in doctor’s offices, and of the
20% they do remember only 50% is remembered correctly. Currently the American
Society of Hematology (ASH) guidelines for optimal management of
anticoagulation therapy suggest supplemental patient education be provided to
patients who are starting anticoagulation therapy.
· Patients with mechanical heart valve
have to take anticoagulant drug therapy throughout their life therefore it
is very important for them to have knowledge regarding anticoagulant drug
therapy. So that they can minimize the risk which can be caused due to
anticoagulants in future.
·
Video assisted teaching
programme is a simple method with broad potential to improve knowledge
regarding anticoagulant drug therapy to post operative patients with mechanical
heart valve. |