The Home INR Study (THINRS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032591
First received: March 27, 2002
Last updated: March 18, 2014
Last verified: March 2014
Results First Received: June 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Procedure: Weekly patient self-testing of prothrombin time
Other: High quality anticoagulation management (HQACM) with conventional monthly testing

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment started in August 2003 and ended at the end of May 2006. Participating sites were VA Medical Centers with anticoagulation services with active rosters of more than 400 patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 3745 participants were consented and screened. Out of this total, 823 were excluded from the study. The majority of those excluded is due to participants not doing or passing the competency assessment.

Reporting Groups
  Description
Patient Self-Testing (PST) Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
High Quality Anticoagulation Management (HQACM) High quality anticoagulation management (HQACM) with conventional monthly testing

Participant Flow for 3 periods

Period 1:   Screening
    Patient Self-Testing (PST)     High Quality Anticoagulation Management (HQACM)  
STARTED     1873 [1]   1872 [2]
COMPLETED     1465 [3]   1457  
NOT COMPLETED     408     415  
[1] 3745 patients provided informed consent and were screened for participation.
[2] Treatment assigned at randomization; screening counts by arm represent half of the total screened.
[3] 823 were excluded from the study

Period 2:   Randomization
    Patient Self-Testing (PST)     High Quality Anticoagulation Management (HQACM)  
STARTED     1465 [1]   1457  
COMPLETED     1465 [2]   1457 [3]
NOT COMPLETED     0     0  
[1] 2922 underwent randomization
[2] 1465 were assigned to self-testing
[3] 1457 were assigned to clinic testing

Period 3:   Follow-up
    Patient Self-Testing (PST)     High Quality Anticoagulation Management (HQACM)  
STARTED     1465 [1]   1457 [2]
COMPLETED     1463 [3]   1452 [4]
NOT COMPLETED     2     5  
[1] 2 were lost to follow-up, both with Atrial Fibrillation, no Mechanical Heart Valves
[2] 5 were lost to follow-up, all with Atrial Fibrillation, no Mechanical Heart Valves
[3] 1463 were included in analysis with greater than 1 day of follow-up
[4] 1452 were included in analysis with greater than 1 day of follow-up



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
3745 participants were screened for participation

Reporting Groups
  Description
Patient Self-Testing (PST) Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
High Quality Anticoagulation Management (HQACM) High quality anticoagulation management (HQACM) with conventional monthly testing
Total Total of all reporting groups

Baseline Measures
    Patient Self-Testing (PST)     High Quality Anticoagulation Management (HQACM)     Total  
Number of Participants  
[units: participants]
  1465     1457     2922  
Age  
[units: years]
Mean ± Standard Deviation
     
Total study population     66.6  ± 9.7     67.4  ± 9.4     67  ± 9.6  
Gender  
[units: participants]
     
Female     25     26     51  
Male     1440     1431     2871  



  Outcome Measures
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1.  Primary:   Time to First Event (Death, Stroke, Major Bleed)   [ Time Frame: Time to event ]

2.  Secondary:   Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent)   [ Time Frame: Full length of follow-up; average of 3 years ]

3.  Secondary:   DASS at 2 Years of Follow-up   [ Time Frame: At two years of follow-up ]

4.  Secondary:   Cumulative Gain in Health Utilities at 2 Year   [ Time Frame: After 2 years of follow-up for each subject ]

5.  Secondary:   Health Care Costs at 2 Year   [ Time Frame: After 2 years of follow-up for each subject ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Bob Edson
Organization: Palo Alto CSPCC
phone: (650) 493-5000 ext 22250
e-mail: Bob.Edson@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032591     History of Changes
Other Study ID Numbers: 481
Study First Received: March 27, 2002
Results First Received: June 12, 2013
Last Updated: March 18, 2014
Health Authority: United States: Federal Government