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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00622102
Other study ID # 806634
Secondary ID
Status Completed
Phase N/A
First received January 15, 2008
Last updated December 1, 2009
Start date December 2007
Est. completion date April 2009

Study information

Verified date December 2009
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

We are performing a research study to learn more about the control of an individual's blood thinning (anticoagulation) on warfarin. Individuals from an anticoagulation clinic are being asked to participate in order to see if a lottery which provides the opportunity to win money in combination with the use of the Med-eMonitor might be useful in helping patients to achieve better control of their anticoagulation therapy. Half of the participants will be enrolled in the lottery arm and the other half will be a control group who will receive the Med-eMonitor only.


Recruitment information / eligibility

Status Completed
Enrollment 101
Est. completion date April 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility Inclusion Criteria:

- 21 years old age or older

- On warfarin managed at the AC clinic

- Target INR 2.0-3.0 or 2.5-3.5

- At maintenance phase of therapy (defined as stable INR with stable warfarin dosing over at least 2 consecutive visits)

Exclusion Criteria:

- Do not have access to telephone line

- Unwillingness to participate or to sign a consent form(refusal)

- Inability to participate because of advances dementia, advanced Alzheimer's disease or other impairment affecting ability to provide informed consent and/or quality data or utilize the Med-eMonitor

- Participation in a current study that does not permit participation in another study

- End stage or terminal illness with anticipated life expectancy of 6 months or less

- INR over the upper limit for the individual's range at the time of enrollment (e.g.,>3.0 or >3.5, depending on the target range)

- Diagnosed with antiphospholipid antibody syndrome or abnormal INR prior to starting warfarin

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research


Intervention

Behavioral:
Lottery arm (Lottery and Med-eMonitor)
Lottery and Med-eMonitor
Non-Lottery (Med-eMonitor only)
Med-eMonitor only

Locations

Country Name City State
United States Hospital of the University of Pennsylvania Anticoagulation Management Center Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Aetna, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary anticoagulation control six months No
Secondary adherence six months No
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