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, 2013
Last verified: October 2013
  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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, 2013
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 July 26, 2014