Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care

This study has been completed.

Sponsor:

Collaborator:

Sorin Group

Information provided by (Responsible Party):

Hartzell V. Schaff, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00703963

First received: June 10, 2008

Last updated: October 23, 2012

Last verified: October 2012

History of Changes

Purpose

The objective of this study is to evaluate the time in therapeutic range of patients who self-test their INR compared to patients receiving the usual care. Additionally, we will evaluate the educational components and corollaries of self-testing.

Condition	Intervention
INR Patient Self Testing. Usual Care.	Device: INRatio monitor by Hemosense

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Diagnostic
Official Title:	Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care: A Randomized Controlled Trial

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

To compare time in therapeutic range between patients that are self-testing, and patients that are being tested in the usual manner by their primary care provider. [ Time Frame: April 2010 ] [ Designated as safety issue: Yes ]

Enrollment:	200
Study Start Date:	March 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Usual Care, patients that will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.	Device: INRatio monitor by Hemosense Home testing monitor to test patients INR by placing a capillary drop of blood from the finger onto a test strip, thus obtaining the result within 2 minutes. Other Names: 1: Usual Care 2: Patient self testing group
Active Comparator: 2 Patient Self Testing, patients that will be testing their INR at home using an FDA approved device (INRatio by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number, their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.	Device: INRatio monitor by Hemosense Home testing monitor to test patients INR by placing a capillary drop of blood from the finger onto a test strip, thus obtaining the result within 2 minutes. Other Names: 1: Usual Care 2: Patient self testing group

Arms

Assigned Interventions

Active Comparator: 1

Usual Care, patients that will be having their INR tested by their Primary Care Provider as often as their Care Provider dictates. This study phase is twelve weeks long beginning at the day of discharge from our hospital.

Device: INRatio monitor by Hemosense

Home testing monitor to test patients INR by placing a capillary drop of blood from the finger onto a test strip, thus obtaining the result within 2 minutes.

Other Names:

1: Usual Care
2: Patient self testing group

Active Comparator: 2

Patient Self Testing, patients that will be testing their INR at home using an FDA approved device (INRatio by Hemosense) reporting their results to Quality Assured Services (QAS) via an 800 phone number, their Primary Care Provider will receive a fax with the INR result. We ask this group of patients to test at minimum one time a week, additional testing as requested by their Primary Care Provider. This phase lasts twelve weeks, beginning on the day of discharge from our hospital.

Device: INRatio monitor by Hemosense

Home testing monitor to test patients INR by placing a capillary drop of blood from the finger onto a test strip, thus obtaining the result within 2 minutes.

Other Names:

1: Usual Care
2: Patient self testing group

Detailed Description:

Two hundred consecutively enrolled adults, having undergone implantation of a mechanical heart valve, will be randomized to either self-testing or usual care. Those randomized to the self-testing group will undergo self-testing instruction prior to hospital dismissal. For three months after hospital discharge, subject will record their INR results obtained by self-testing or as prescribed by their primary physician. They will then submit the record of the INR results and complete a survey.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients that received a mechanical valve while in our hospital and are over the age of 18.

Exclusion Criteria:

patients under the age of 18
patients that have genetic clotting disorders such as Factor 5.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703963

Locations

United States, Minnesota
Saint Marys Hospital
Rochester, Minnesota, United States, 55906

Sponsors and Collaborators

Mayo Clinic

Sorin Group

Investigators

Principal Investigator:

Hartzell V Schaff, M.D. CS

Mayo Clinic

More Information

No publications provided

Responsible Party:	Hartzell V. Schaff, PI, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00703963 History of Changes
Other Study ID Numbers:	07-001398
Study First Received:	June 10, 2008
Last Updated:	October 23, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Mayo Clinic:

Compare Self testing group with the Usual care group.

ClinicalTrials.gov processed this record on May 19, 2013

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