Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06187155
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2023-12-16
Brief Title:
Impact of Education Level on Clinical Outcomes in Self-INR Managed Patients
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Impact of Education Level on Clinical Outcomes in Self-INR Managed Patients on Longterm Warfarin a Single-center Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Oral anticoagulation OAC is indicated in a wide variety of clinical conditions including atrial fibrillation AF mechanical valve prosthesis MVP deep vein thrombosis and pulmonary embolism Although direct OAC has replaced vitamin K antagonists VKA in non-valvular AF due to lower bleeding risk its still recommended to use VKA specifically in cases of valvular AF MVP and anti-phospholipid syndrome
VKA has a narrow therapeutic range and multiple drug interactions causing unpredicted pharmacodynamics This requires regular monitoring of the international normalized ratio INR level to ensure its in the target therapeutic range and prevent extreme values that may result in thrombo-embolic events or sometimes fatal bleeding
Self-INR monitoring and management have emerged recently as a safe cost-effective alternative to standard management with evidence of tighter control of INR reduction of thrombo-embolic events and improving treatment-related quality of life However there are no specific criteria for patient selection Whether the level of education and other social factors would affect the outcomes of self-management is still not clear
Owing to the wide geographical area served by Aswan Heart Center many patients have to cover long distances to follow up their INR and seek medical advice regarding adequate dose modification This may result in reluctance and non-compliance to clinic visits and INR testing Proper education training and providing an alternative near place to measure the INR and self-adjust warfarin dose is expected to improve patient adherence and compliance
VKA has a narrow therapeutic range and multiple drug interactions causing unpredicted pharmacodynamics This requires regular monitoring of the international normalized ratio INR level to ensure its in the target therapeutic range and prevent extreme values that may result in thrombo-embolic events or sometimes fatal bleeding
Self-INR monitoring and management have emerged recently as a safe cost-effective alternative to standard management with evidence of tighter control of INR reduction of thrombo-embolic events and improving treatment-related quality of life However there are no specific criteria for patient selection Whether the level of education and other social factors would affect the outcomes of self-management is still not clear
Owing to the wide geographical area served by Aswan Heart Center many patients have to cover long distances to follow up their INR and seek medical advice regarding adequate dose modification This may result in reluctance and non-compliance to clinic visits and INR testing Proper education training and providing an alternative near place to measure the INR and self-adjust warfarin dose is expected to improve patient adherence and compliance
Detailed Description:
Study Methods
Population of study Patients who have a clinical indication for long term VKA
Study location Aswan Heart Center
Inclusion criteria Adult patients above 18 years who are indicated for long term VKA and has been on VKA for more than 6 months
Exclusion criteria
1 Refusal to join the study 2 History of life-threatening bleeding or thrombo-embolic events 3 Illiterate patients with no caregivers living at the same home
Patient informed consent
Individual informed consent will be taken from every candidate for the study The candidates will have the right to withdraw from the study at any time without any changes in the clinical service provided to them
- Methodology in details
A-Medical history including
Age gender indication of VKA Data about valve surgery including date location and type of valve Past history of any chronic medical conditions thrombo-embolic or bleeding events Past history of blood transfusion
B-Social history including
Marital status occupation level of education and self-care capability
C- Clinical examination including
Assessment of body weight height and body mass index calculation Vital signs including blood pressure measurement using standard technique assessment of the pulse respiratory rate and temperature
C- Blood sample and chemistry
Blood tests will be done for all participants initially and at the end of the study Laboratory workup will include complete blood count liver kidney function tests and electrolytes
F- Electrocardiography ECG
12-lead ECG will be done for all participants initially and the end of the study to confirm rhythm
H- Echocardiography
Trans-thoracic echocardiography will be done for all patients to assess valve function leaflet excursion peak and mean pressure gradients across the valve
In case of abnormally elevated pressure gradients abnormal leaflet motion or suspected prosthesis-related mass trans-oesophageal echocardiography will be done to confirm or exclude MVP malfunction
I Randomization
Patients will be randomized with the ratio of 11 to undergo self-management of INR versus standard management in the anticoagulation clinic using a randomization table
Self-management arm
All participants will receive full education class of minimum one-hour time and training about how to interpret INR levels and adjust their medication dose according to a pre-determined dose-INR schedule
A registered nurse will be responsible for education and training Another registered nurse would be responsible to check the participant feedback and well-understanding
The participant will receive a chart to record INR results test dates and dose modifications for the upcoming 6 months
The participant will be educated about bleeding events how to grade and when to seek medical attention immediately
The participant will be educated about early manifestations of thrombo-embolism including shortness of breath focal neurological deficits or lower limb pain
If INR exceeds 8 at any time the participant will be instructed to urgently contact the center and seek medical advice heshe will be withdrawn from the trial and switched to the standard monitoring care
If major bleeding or thrombotic event occurred the participant will be instructed to contact us urgently and will be withdrawn from the trial and switched to the standard monitoring care
Standard monitoring arm
This group will be managed according to the local protocol of INR monitoring in a dedicated anticoagulation clinic A registered nurse supervised by a physician would be responsible for medication dose adjustment scheduling tests and recording any thrombo-embolic or bleeding events
K Follow-up
Standard monitoring group will be reviewed on monthly basis or less according to INR test results Self-management group will be reviewed 6 months after randomization with the following data to be obtained
1 All-cause death
2 Bleeding events will be graded according to BARC classification
Minor bleeding Type 1 self-controlled bleeding that doesnt need seeking medical advice
Major bleeding Type 2 Overt bleeding that requires medical intervention or hospitalization Type 3a Bleeding with Hb drop 3-5 gmdL or requiring blood transfusion Type 3b Bleeding with Hb drop 5 gmdL or more or requiring surgical intervention
Type 4 Coronary artery bypass graft-related bleeding Type 5 Fatal bleeding 4 Thrombo-embolic event defined as mechanical valve thrombosis confirmed by trans-oesophageal echocardiography prosthesis-related mass elevated gradients stuck leaflet motion cerebrovascular stroke peripheral embolism causing acute limb ischemia
5 Time and proportion of tests in therapeutic range will be calculated using Rosendaal method
6 Frequency of tests will be recorded
In case of mortality data will be collected about the date and cause of mortality and any reported clinical events before mortality
Data will be presented and used without inference to the name or personal data of the patients All patient records will be handled in accordance to hospital and national confidentiality protocols
Population of study Patients who have a clinical indication for long term VKA
Study location Aswan Heart Center
Inclusion criteria Adult patients above 18 years who are indicated for long term VKA and has been on VKA for more than 6 months
Exclusion criteria
1 Refusal to join the study 2 History of life-threatening bleeding or thrombo-embolic events 3 Illiterate patients with no caregivers living at the same home
Patient informed consent
Individual informed consent will be taken from every candidate for the study The candidates will have the right to withdraw from the study at any time without any changes in the clinical service provided to them
- Methodology in details
A-Medical history including
Age gender indication of VKA Data about valve surgery including date location and type of valve Past history of any chronic medical conditions thrombo-embolic or bleeding events Past history of blood transfusion
B-Social history including
Marital status occupation level of education and self-care capability
C- Clinical examination including
Assessment of body weight height and body mass index calculation Vital signs including blood pressure measurement using standard technique assessment of the pulse respiratory rate and temperature
C- Blood sample and chemistry
Blood tests will be done for all participants initially and at the end of the study Laboratory workup will include complete blood count liver kidney function tests and electrolytes
F- Electrocardiography ECG
12-lead ECG will be done for all participants initially and the end of the study to confirm rhythm
H- Echocardiography
Trans-thoracic echocardiography will be done for all patients to assess valve function leaflet excursion peak and mean pressure gradients across the valve
In case of abnormally elevated pressure gradients abnormal leaflet motion or suspected prosthesis-related mass trans-oesophageal echocardiography will be done to confirm or exclude MVP malfunction
I Randomization
Patients will be randomized with the ratio of 11 to undergo self-management of INR versus standard management in the anticoagulation clinic using a randomization table
Self-management arm
All participants will receive full education class of minimum one-hour time and training about how to interpret INR levels and adjust their medication dose according to a pre-determined dose-INR schedule
A registered nurse will be responsible for education and training Another registered nurse would be responsible to check the participant feedback and well-understanding
The participant will receive a chart to record INR results test dates and dose modifications for the upcoming 6 months
The participant will be educated about bleeding events how to grade and when to seek medical attention immediately
The participant will be educated about early manifestations of thrombo-embolism including shortness of breath focal neurological deficits or lower limb pain
If INR exceeds 8 at any time the participant will be instructed to urgently contact the center and seek medical advice heshe will be withdrawn from the trial and switched to the standard monitoring care
If major bleeding or thrombotic event occurred the participant will be instructed to contact us urgently and will be withdrawn from the trial and switched to the standard monitoring care
Standard monitoring arm
This group will be managed according to the local protocol of INR monitoring in a dedicated anticoagulation clinic A registered nurse supervised by a physician would be responsible for medication dose adjustment scheduling tests and recording any thrombo-embolic or bleeding events
K Follow-up
Standard monitoring group will be reviewed on monthly basis or less according to INR test results Self-management group will be reviewed 6 months after randomization with the following data to be obtained
1 All-cause death
2 Bleeding events will be graded according to BARC classification
Minor bleeding Type 1 self-controlled bleeding that doesnt need seeking medical advice
Major bleeding Type 2 Overt bleeding that requires medical intervention or hospitalization Type 3a Bleeding with Hb drop 3-5 gmdL or requiring blood transfusion Type 3b Bleeding with Hb drop 5 gmdL or more or requiring surgical intervention
Type 4 Coronary artery bypass graft-related bleeding Type 5 Fatal bleeding 4 Thrombo-embolic event defined as mechanical valve thrombosis confirmed by trans-oesophageal echocardiography prosthesis-related mass elevated gradients stuck leaflet motion cerebrovascular stroke peripheral embolism causing acute limb ischemia
5 Time and proportion of tests in therapeutic range will be calculated using Rosendaal method
6 Frequency of tests will be recorded
In case of mortality data will be collected about the date and cause of mortality and any reported clinical events before mortality
Data will be presented and used without inference to the name or personal data of the patients All patient records will be handled in accordance to hospital and national confidentiality protocols
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None