Skip to content

Assessing the effectiveness, safety and cost-effectiveness of the “Safe Multidisciplinary App-Assisted Remote Patient-Self-Testing (SMART) Model” for warfarin home management: a multi-center randomized controlled trial

Assessing the effectiveness, safety and cost-effectiveness of the “Safe Multidisciplinary App-Assisted Remote Patient-Self-Testing (SMART) Model” for warfarin home management: a multi-center randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038984
Enrollment
Unknown
Registered
2020-10-11
Start date
2020-11-02
Completion date
Unknown
Last updated
2021-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart diseases

Interventions

SMART group:SMART model management
usual care clinic group:No intervention, patients will be managed in the usual care clinics
anticoagulation clinic group:No intervention, patients will be managed in the anticoagulation clinics

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who will continue to take warfarin in the next 12 months; 2. Patients who followed the protocol and randomization; 3. Patients who signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects of pregnancy or pregnancy plan in the next 18 months; 2. Those who had been treated for bleeding adverse events in the past 6 months; 3. Those who can't go to the hospital within 6 hours; 4. Patients with advanced renal failure (hemodialysis or glomerular clearance rate < 10ml / min) 5. Patients with senile dementia or schizophrenia; 6. Patients receiving anti-cancer treatment; 7. Patients with congestive heart failure who need medical treatment; 8. Patients with history of bleeding such as gastric ulcer; 9. Patients taking aspirin and other antiplatelet drugs at the same time.

Design outcomes

Primary

MeasureTime frame
The percentage of time in therapeutic range;

Secondary

MeasureTime frame
the numbers of INR results 5.0;serious adverse clinical events;patients’ quality of life;

Countries

China

Contacts

Public ContactShenglan Tan

The Second Xiangya Hospital of Central South University

94794635@qq.com+86 13467589877

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026