Atrial FibrillationPhase 4NCT01513031
Determination of Rates and Reasons for Non-Adherence to Anti-Arrhythmic Therapy for Atrial Fibrillation
A Phase 4 study testing Education and telephone follow-up in people with Atrial Fibrillation and Medication Adherence, run by Creighton University at 3 sites in United States.
Trial summary
The purpose of this study is to determine if follow-up by a pharmacist over the telephone improves adherence and short term clinical outcomes in the patient with atrial fibrillation prescribed an oral anti-arrhythmic medication. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation, Medication Adherence
- What is being tested?
- Education and telephone follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2012to Jun 2012
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prescribed a new anti-arrhythmic medication for atrial fibrillation
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bryan LGH
Lincoln, Nebraska, 68506
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Creighton University
Omaha, Nebraska, 68178
About this study
Official title: Pilot Project to Determine Rates and Reasons for Non-Adherence in Patients Receiving Chronic Oral Antiarrhythmic Therapy for Atrial Fibrillation in the State of Nebraska
The purpose of this study is to determine if follow-up by a pharmacist over the telephone improves adherence and short term clinical outcomes in the patient with atrial fibrillation prescribed an oral anti-arrhythmic medication. This study will also identify the reasons people stop taking their anti-arrhythmic therapy. A pharmacist will provide medication counseling about their anti-arrhythmic therapy, then will follow-up by telephone on a monthly basis to assess adherence over one year.
- Conditions
- Atrial Fibrillation, Medication Adherence
- Being tested
- Education and telephone follow-up
- Keywords
- Atrial fibrillation, Anti-arrhythmic medication, Medication adherence
- Medical subject headings
- Atrial Fibrillation, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and telephone follow-upOther
Education related to anti-arrhythmic therapy and monthly telephone follow-up to assess adherence to medication.
| Study group | Role | What they receive |
|---|---|---|
| Phone follow-up | Experimental | All study participants will be receiving education and monthly telephone follow-up. Receives: Other: Education and telephone follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to anti-arrhythmic medication
Assessing whether patients stop taking anti-arrhythmic medication without instruction to do so by their physician.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: Low enrollment
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.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Dan Hilleman, PharmD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513031
- Sponsor's protocol ID
- DRONE_L_06034
- Other IDs
- 11-16223
- Status last verified
- Jun 2012
- First submitted
- 16 Jan 2012
- Last updated
- 2 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Project to Determine Rates and Reasons for Non-Adherence in Patients Receiving Chronic Oral Antiarrhythmic Therapy for Atrial Fibrillation in the State of Nebraska
- ClinicalTrials.gov ID
- NCT01513031
- Acronym / sponsor ID
- DRONE_L_06034
- Conditions
- Atrial Fibrillation, Medication Adherence
- Keywords
- Atrial fibrillation, Anti-arrhythmic medication, Medication adherence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Jan 2012 (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.
The purpose of this study is to determine if follow-up by a pharmacist over the telephone improves adherence and short term clinical outcomes in the patient with atrial fibrillation prescribed an oral anti-arrhythmic medication. This study will also identify the reasons people stop taking their anti-arrhythmic therapy. A pharmacist will provide medication counseling about their anti-arrhythmic therapy, then will follow-up by telephone on a monthly basis to assess adherence over one year.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phone follow-up | Experimental | Other: Education and telephone follow-upAll study participants will be receiving education and monthly telephone follow-up. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Prescribed a new anti-arrhythmic medication for atrial fibrillation
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Education and telephone follow-upEducation related to anti-arrhythmic therapy and monthly telephone follow-up to assess adherence to medication. | Other | Phone follow-up |
Primary outcome
Adherence to anti-arrhythmic medication
Time frame: 1 year
Assessing whether patients stop taking anti-arrhythmic medication without instruction to do so by their physician.
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2012.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Dan Hilleman, PharmD principal investigator
Creighton University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Education and telephone follow-up in people with Atrial Fibrillation and Medication Adherence, run by Creighton University at 3 sites 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 1 inclusion and 0 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: stopped early, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
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?
Adherence to anti-arrhythmic medication (time frame: 1 year). 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 Jul 2012.