| CTRI Number |
CTRI/2025/05/086430 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
06/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Mobile Application based educational intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of a Mobile-Application based educational intervention Vs. Routine care and booklet-based education among Cerebral Venous Thrombosis (CVT) Stroke patients on anticoagulation therapy at a tertiary care centre. |
|
Scientific Title of Study
|
To compare the effectiveness of a Mobile-Application based educational intervention Vs. Routine care along with booklet based education on Anticoagulation treatment compliance, knowledge and INR control among Cerebral Venous Thrombosis (CVT) Stroke patients on anticoagulation therapy at a tertiary care centre A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR GOPICHANDRAN L |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES,BANGALORE |
| Address |
ROOM NO 6 DEPARTMENT OF NURSING
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGALORE
ROOM NO 6 DEPARTMENT OF NURSING, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGALORE
Bangalore
KARNATAKA
560029
India |
| Phone |
8130930287 |
| Fax |
|
| Email |
pravigopi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GOPICHANDRAN L |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES |
| Address |
ROOM NO6 DEPARTMENT OF NURSING,
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGALORE-29
ROOM NO 6 DEPARTMENT OF NURSING
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGALORE-29
Bangalore
KARNATAKA
560029
India |
| Phone |
8130930287 |
| Fax |
|
| Email |
pravigopi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GOPICHANDRAN L |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES |
| Address |
ROOM NO 6 DEPARTMENT OF NURSING
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGALORE-29
ROOM NO 6 DEPARTMENT OF NURSING
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGALORE-29
Bangalore
KARNATAKA
560029
India |
| Phone |
8130930287 |
| Fax |
|
| Email |
pravigopi@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGALORE INDIA- 560029 |
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
NIMHANS, Bangalore-29 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gopichandran L |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEURO SCIENCES, |
ROOM NO 6 DEPARTMENT OF NURSING
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES BANGALORE-29
Bangalore
KARNATAKA |
8130930287
pravigopi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITEE(BASIC AND NEUROSCIENCES DIVISION),NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G939||Disorder of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobile app-based educational intervention |
Intervention (x):
Downloading mobile app in smartphones of patient or caregiver by the investigator at baseline.
• Training the patient and/or caregiver in app usage.
Mobile-Application-based educational intervention
Components of mobile app:
– Consists
Knowledge on anticoagulation therapy
– which consist information regarding
What is Anticoagulation
Why we use anticoagulants?
How they do work?
Why we need to take anticoagulants?
How to take anticoagulants?
What to do if you miss a dose?
What are the side effect of anticoagulants?
What is the diet plan you have to follow while taking anticoagulants?
What are the meals you should have avoided while taking anticoagulants?
What is INR value?
Why its INR important to those patients, taking anticoagulants?
2) Settings to upload prescribed medicines
3) Medication alert displaying prescribed medicines with scheduled timing
4) Setting to track taken/missed doses
5) Setting to upload INR values
6) Reminder messages for follow visits
Reinforcement:
 At baseline: Encouraging adherence to anticoagulant as well as app compliance
 On daily basis: Reinforcing anticoagulant compliance through reminder messages.
 Two weekly: Reinforcing anticoagulant compliance , Report the INR value regularly by patients. Clarifying doubts regarding the app
|
| Comparator Agent |
Routine care along with booklet education |
CVT stroke patients registered in Neurology OPD visit physicians with registered file and Outpatient Department Card. Anticoagulation will be prescribed after assessing and diagnose the patients; Physician will explain the prescribed medicines in a comprehensive manner. Patients will be informed about the next follow up visit. The study participants in the routine care group will be encouraged to maintain compliance to dosage and frequency of INR monitoring on Outpatient Department card at baseline and every two weekly and maintain in the compliance logbook by patients/family members. The concerns about Anticoagulation and its side effects will be addressed properly. Education will be imparted through educational booklet regarding anticoagulation and its management to them at baseline and the booklet will be given to them. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged above 18 years old to 75 years old.
2.Patient who developed cerebral venous thrombosis stroke.
3.Patients who have Smartphones.
4.Patient willing to participate in the study
5.Patients who can understand Kannada or English language.
|
|
| ExclusionCriteria |
| Details |
1.Patients who have any chronic and mental disease.
2.Patients who have any other major surgery.
3.Patients who have bleeding disorders.
4.Previously had a structured education about warfarin.
5.Patients who have visual or hearing impairment.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Anticoagulation knowledge
2. Anticoagulation compliance
|
Base line, one month, three months and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. INR CONTROL |
Base line, one month, three months & six months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
31/05/2025 |
| 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="1"
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
|
cerebral Venous Thrombosis (CVT) is a rare
but potentially life-threatening condition characterized by the formation of
blood clots in the cerebral veins. Effective management of CVT includes
anticoagulation therapy, strict medication adherence, and close monitoring of
the International Normalized Ratio (INR) to prevent the complications of
CVT stroke patients. Bleeding, recurrence of thrombosis, INR fluctuations, drug
interactions are complications or adverse outcomes in the management of CVT
patients. This randomized
controlled trial (RCT) to assess and compare the utility of two distinct
educational interventions, a Mobile –Application based educational intervention
and Routine care along with booklet –based education on Anti Coagulation
Compliance, knowledge and INR control among Cerebral Venous Thrombosis (CVT)
Stroke patients.
|