Atrial FibrillationNCT00622102
Testing Strategies to Improving Warfarin Adherence
A study testing Lottery arm (Lottery and Med-eMonitor) and Non-Lottery (Med-eMonitor only) in people with Atrial Fibrillation and Deep Venous Thrombosis, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation, Deep Venous Thrombosis, Dilated Cardiomyopathies
- What is being tested?
- Lottery arm (Lottery and Med-eMonitor) and Non-Lottery (Med-eMonitor only)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Apr 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania Anticoagulation Management Center
Philadelphia, Pennsylvania, 19104
About this study
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.
- Being tested
- Lottery arm (Lottery and Med-eMonitor), Non-Lottery (Med-eMonitor only)
- Keywords
- warfarin, adherence, Mechanical heart valves
- Medical subject headings
- Atrial Fibrillation, Venous Thrombosis, Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lottery arm (Lottery and Med-eMonitor)Behavioural
Lottery and Med-eMonitor
Non-Lottery (Med-eMonitor only)Behavioural
Med-eMonitor only
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence Receives: Behavioral: Lottery arm (Lottery and Med-eMonitor) |
| 2 | Other | 50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence Receives: Behavioral: Non-Lottery (Med-eMonitor only) |
What is being measured
The primary outcome is the main question the study is designed to answer.
anticoagulation control
Measured: six months
Secondary outcomes (1)
adherence
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Aetna, Inc.
- Investigators
- Kevin G Volpp, M.D., Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622102
- Sponsor's protocol ID
- 806634
- Status last verified
- Dec 2009
- First submitted
- 15 Jan 2008
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Strategies to Improving Warfarin Adherence
- ClinicalTrials.gov ID
- NCT00622102
- Acronym / sponsor ID
- 806634
- Keywords
- warfarin, adherence, Mechanical heart valves
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Aetna, Inc.
- Study start
- Dec 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Lottery arm (Lottery and Med-eMonitor)50% of the consenting subjects will take part in the lottery and use the Med-eMonitor as a device to monitor adherence |
| 2 | Other | Behavioral: Non-Lottery (Med-eMonitor only)50% of the consenting subjects will use only the Med-eMonitor as a device to monitor adherence |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lottery arm (Lottery and Med-eMonitor)Lottery and Med-eMonitor | Behavioural | 1 |
| Non-Lottery (Med-eMonitor only)Med-eMonitor only | Behavioural | 2 |
Primary outcome
anticoagulation control
Time frame: six months
1 secondary outcome
adherence
Time frame: six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin G Volpp, M.D., Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lottery arm (Lottery and Med-eMonitor) and Non-Lottery (Med-eMonitor only) in people with Atrial Fibrillation and Deep Venous Thrombosis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anticoagulation control (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2009.