Trial · NCT00032591
The Home INR Study
NCT00032591, Phase 4, Completed, US Department of Veterans Affairs; results first posted 2014-02-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Home INR Study. Trials, record NCT00032591. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00032591
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Home INR Study
- NCT number
- NCT00032591
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,922 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Atrial Fibrillation
- Interventions
- Weekly patient self-testing of prothrombin time, High quality anticoagulation management (HQACM) with conventional monthly testing
- First posted
- 2002-03-28
- Last updated
- 2014-04-15
- Results first posted
- 2014-02-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to First Event (Death, Stroke, Major Bleed) | Time to event | Time to first event (death, stroke, major bleed) The primary outcome was time to first event, and we used the Kaplan-Meier method to compare survival curves and the results using the log-rank test. The number of patients with a primary outcome is what was reported in the NEJM paper. Below is the unpublished cumulative incidence information. |
| Secondary | Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent) | Full length of follow-up; average of 3 years | Time in target range (TTR) based on Prothrombin Time standardized to the International Normalized Ratio |
| Secondary | DASS at 2 Years of Follow-up | At two years of follow-up | Satisfaction with care was quantified using the Duke Anticoagulation Satisfaction Scale (DASS). Scores range from 25 to 225, with lower scores indicating higher satisfaction. |
| Secondary | Cumulative Gain in Health Utilities at 2 Year | After 2 years of follow-up for each subject | Scores range from -0.36 to 1.00 per year, with a negative score indicating a state worse than being dead and a score of 1.00 indicating perfect health. Since the time frame is 2 years, the range is -0.72 to 2.00. |
| Secondary | Health Care Costs at 2 Year | After 2 years of follow-up for each subject |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to First Event (Death, Stroke, Major Bleed) | Time to event | Randomized participants with at least one day of follow-up, per intent to treat | cumulative probability of event | NUMBER |
| SECONDARY | Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent) | Full length of follow-up; average of 3 years | Randomized participants with at least one day of follow-up, per intent to treat | percentage | MEAN |
| SECONDARY | DASS at 2 Years of Follow-up | At two years of follow-up | Randomized participants with at least one day of follow-up, per intent to treat | score | MEAN |
| SECONDARY | Cumulative Gain in Health Utilities at 2 Year | After 2 years of follow-up for each subject | Randomized participants with at least one day of follow-up, per intent to treat | score | MEAN |
| SECONDARY | Health Care Costs at 2 Year | After 2 years of follow-up for each subject | Randomized participants with at least one day of follow-up, per intent to treat | U.S. Dollars | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to First Event (Death, Stroke, Major Bleed) | Patient Self-Testing (PST) | Cumulative Incidence at 500 Days | 0.0785 | 95% Confidence Interval 0.0645 to 0.0925 | cumulative probability of event |
| Time to First Event (Death, Stroke, Major Bleed) | High Quality Anticoagulation Management (HQACM) | Cumulative Incidence at 500 Days | 0.0987 | 95% Confidence Interval 0.0830 to 0.1144 | cumulative probability of event |
| Time to First Event (Death, Stroke, Major Bleed) | Patient Self-Testing (PST) | Cumulative Incidence at 1000 Days | 0.1542 | 95% Confidence Interval 0.1349 to 0.1734 | cumulative probability of event |
| Time to First Event (Death, Stroke, Major Bleed) | High Quality Anticoagulation Management (HQACM) | Cumulative Incidence at 1000 Days | 0.1820 | 95% Confidence Interval 0.1610 to 0.2031 | cumulative probability of event |
| Time to First Event (Death, Stroke, Major Bleed) | Patient Self-Testing (PST) | Cumulative Incidence at 1500 Days | 0.2268 | 95% Confidence Interval 0.2002 to 0.2535 | cumulative probability of event |
| Time to First Event (Death, Stroke, Major Bleed) | High Quality Anticoagulation Management (HQACM) | Cumulative Incidence at 1500 Days | 0.2524 | 95% Confidence Interval 0.2229 to 0.2818 | cumulative probability of event |
| Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent) | Patient Self-Testing (PST) | 66.2 | Standard Deviation 14.2 | percentage | |
| Time in Therapeutic Range Over Full Length of Follow-up (0 to 100 Percent) | High Quality Anticoagulation Management (HQACM) | 62.4 | Standard Deviation 17.1 | percentage | |
| DASS at 2 Years of Follow-up | Patient Self-Testing (PST) | 46.8 | Standard Deviation 16.3 | score | |
| DASS at 2 Years of Follow-up | High Quality Anticoagulation Management (HQACM) | 49.2 | Standard Deviation 18.0 | score |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Screening | STARTED | Patient Self-Testing (PST) | 1,873 | |
| Screening | STARTED | High Quality Anticoagulation Management (HQACM) | 1,872 | |
| Screening | COMPLETED | Patient Self-Testing (PST) | 1,465 | |
| Screening | COMPLETED | High Quality Anticoagulation Management (HQACM) | 1,457 | |
| Screening | NOT COMPLETED | Patient Self-Testing (PST) | 408 | |
| Screening | NOT COMPLETED | High Quality Anticoagulation Management (HQACM) | 415 | |
| Randomization | STARTED | Patient Self-Testing (PST) | 1,465 | |
| Randomization | STARTED | High Quality Anticoagulation Management (HQACM) | 1,457 | |
| Randomization | COMPLETED | Patient Self-Testing (PST) | 1,465 | |
| Randomization | COMPLETED | High Quality Anticoagulation Management (HQACM) | 1,457 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events660
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abrasions | Injury, poisoning and procedural complications | Patient Self-Testing (PST) | 2 | 1,465 | 2 |
| other | Abrasions | Injury, poisoning and procedural complications | High Quality Anticoagulation Management (HQACM) | 1 | 1,457 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Patient Self-Testing (PST) | 1 | 1,465 | 1 |
| other | Anemia | Blood and lymphatic system disorders | High Quality Anticoagulation Management (HQACM) | 0 | 1,457 | 0 |
| other | Anemia postoperative | Injury, poisoning and procedural complications | Patient Self-Testing (PST) | 0 | 1,465 | 0 |
| other | Anemia postoperative | Injury, poisoning and procedural complications | High Quality Anticoagulation Management (HQACM) | 2 | 1,457 | 2 |
| other | Arteriovenous graft site hemorrhage | Injury, poisoning and procedural complications | Patient Self-Testing (PST) | 0 | 1,465 | 0 |
| other | Arteriovenous graft site hemorrhage | Injury, poisoning and procedural complications | High Quality Anticoagulation Management (HQACM) | 1 | 1,457 | 4 |
| other | Arteriovenous malformation | Congenital, familial and genetic disorders | Patient Self-Testing (PST) | 0 | 1,465 | 0 |
| other | Arteriovenous malformation | Congenital, familial and genetic disorders | High Quality Anticoagulation Management (HQACM) | 1 | 1,457 | 1 |
1 to 10 of 660Source ClinicalTrials.gov
See all 660 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Patient Self-Testing (PST) | ||
| Total, all-cause mortality | High Quality Anticoagulation Management (HQACM) | ||
| Total, other adverse events | Patient Self-Testing (PST) | 399 | 1,465 |
| Total, other adverse events | High Quality Anticoagulation Management (HQACM) | 332 | 1,457 |
| Total, serious adverse events | Patient Self-Testing (PST) | 247 | 1,465 |
| Total, serious adverse events | High Quality Anticoagulation Management (HQACM) | 250 | 1,457 |
Source ClinicalTrials.gov
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Patient Self-Testing (PST) vs High Quality Anticoagulation Management (HQACM): serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00032591
GET https://conductscience.org/api/trials/v1/NCT00032591/events?page=2