The current study is designed in order to investigate the effect of nurse-led care on stability time in therapeutic range of INR (International Normalized Ratio) in ischemic stroke patients receiving Warfarin. Patients with ischemic stroke whose disease is confirmed by a neurologist doctor and referred to warfarin clinics in the specified time range of the study, and those taking warfarin for one month before starting the study were included. Patients who have to be discontinued warfarin for any reason, died during the study period due to complications from a stroke or other causes, and did not provide the necessary cooperation were excluded. In this 80 ischemic stroke patients including 40 patients in experimental group and 40 patients in the control group who referred to the nurse-based warfarin clinics affiliated to Shiraz University of Medical Sciences in 2013 were evaluated.
General information
Acronym
INR: international normalized ratio
IRCT registration information
IRCT registration number:IRCT2016021626581N1
Registration date:2016-04-12, 1395/01/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-12, 1395/01/24
Registrant information
Name
Marzieh Kargar
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 5016
Email address
kargar.m@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Nurse-led Care on Stability Time in Therapeutic Range of INR in Ischemic Stroke Patients Receiving Warfarin
Public title
The Effect of Nurse-led Care on Stability Time in Therapeutic Range Ischemic Stroke Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients with ischemic stroke have been one reason; Patients whose disease is confirmed by a neurologist doctor and refer to warfarin clinics in Specified time range of in the study; Patients under 76 years are allowed to enter the study; Patients who live in shiraz or around the city of Shiraz and refer to clinic in the established days; Patients who are committed to the principles of the laboratory tests are required to use the unit for lab test checking; Patients willing to participate in the study and signed an informed consent form 7 Patients taking warfarin for one month before starting the study
Exclusion criteria: Patients who have to be discontinued warfarin for any reason; Deaths during the study period due to complications from a stroke or other causes; Patients did not provide the necessary cooperation to control their INR during the study period
Age
From 20 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Research center, floor 7, Central Building University of Medical Sciences,Next to the Red Crescent, zand st
City
Shiraz
Postal code
1978 -71345
Approval date
2012-12-24, 1391/10/04
Ethics committee reference number
CT-91-6377
Health conditions studied
1
Description of health condition studied
ischaemic stroke
ICD-10 code
G 45 ,G 46
ICD-10 code description
Transient cerebral ischaemic attacks and related syndromes ,Vascular syndromes of brain in cerebrovascular diseases
Primary outcomes
1
Description
INR
Timepoint
Baseline and then at intervals required
Method of measurement
blood test
Secondary outcomes
1
Description
Recurrent stroke and bleeding
Timepoint
At each visit of patients
Method of measurement
question and observation
Intervention groups
1
Description
control group: Lab tests for patients Adjusting the dose patients according to clinical protocols that have been developed based on the latest available protocols thrombotic therapy Determine the therapeutic range of INR
Category
Other
2
Description
Intervention group: Lab tests for patients The necessary training related to using warfarin correctly To familiarize the patients with risk factors for recurrent stroke and bleeding and help in controlling them Adjusting the warfarin dose according to clinical protocols that have been developed based on the latest available protocols of thrombotic therapy educating the importance of treatment follow-up Determine the therapeutic range of INR
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Imam Reza (AS)
Full name of responsible person
Afshin Borhani Haghighi
Street address
Clinic of Imam Reza (AS), Namazi Square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
Research center, floor 7, Central Building University of Medical Sciences,Next to the Red Crescent, zand st
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mrs. M. kargar (Executive)
Position
Master of Nursing
Other areas of specialty/work
Street address
Nursing and midwifery School
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
kargarm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
M. kargar
Position
Master of Nursing
Other areas of specialty/work
Street address
Nursing and midwifery School
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
kargarm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mina Amiri
Position
Bachelor of nursing
Other areas of specialty/work
Street address
Nursing and midwifery School
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)