Clinical trial NCT00703963: Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care
Official title: Improved Time in Therapeutic Range With Patient Self-Testing of Their INR Compared to Usual Care: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Management of Anticoagulation
Keywords: International normalized ratio (INR)
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: LivaNova
First posted: 2008-06-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients who receive a mechanical heart valve to replace a diseased heart valve must take an anticoagulation medicine the rest of their lives, and monitor their level of anticoagulation. Until recently, the testing of the level of anticoagulation was performed at medical laboratories or hospitals.

The purpose of this study is to see if patients who test their level of anticoagulation by themselves at home and then call their doctor with the result have better control of their anticoagulation as compared to patients whose anticoagulation is checked only by their physician.

Detailed description: Prosthetic replacement of diseased heart valves is a routine procedure, and mechanical heart valves have excellent hemodynamic performance and durability. However, mechanical valves are thrombogenic, necessitating lifelong anticoagulation. Hazards of anticoagulation include bleeding when it is excessive or thromboembolism when the intensity of anticoagulation is below the recommended level. Monitoring the level of anticoagulation is accomplished by analyzing the International Normalized Ratio. Until recently, this was performed at medical laboratories or hospitals, but recent literature suggests that patient self-testing of oral anticoagulation improves patient compliance, medical outcomes, and quality of life.

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.

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 criteria: Inclusion Criteria:

* Patients that received a mechanical valve while in our hospital
* Age \> 18 years

Exclusion Criteria:

* Pregnant or lactating women
* Patients that have genetic clotting disorders such as Factor 5
* Physical disabilities (for example, poor eyesight, tremor, or other neurological disability) that would prevent the patient from being able to perform finger stick blood sampling. (Patients may not be excluded for physical disabilities if a care giver is willing to learn and assist with performing patient self-testing.)

Primary outcomes:
measure: Mean Percentage of Time in Therapeutic Range
timeFrame: baseline to 3 months
Secondary outcomes:
measure: Mean Percentage of INR Tests Within the Therapeutic Range
timeFrame: baseline to 3 months
measure: Mean Number of INR Tests Performed
timeFrame: baseline to 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Saint Marys Hospital
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Hartzell V Schaff, M.D. CS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson JL, Burkhart HM, Daly RC, Dearani JA, Joyce LD, Suri RM, Schaff HV. Anticoagulation early after mechanical valve replacement: improved management with patient self-testing. J Thorac Cardiovasc Surg. 2013 Sep;146(3):599-604. doi: 10.1016/j.jtcvs.2012.03.088. Epub 2012 Aug 24.