Atrial FibrillationPhase 1AFIBNCT00829478
Improving the Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making
A Phase 1 study testing Decision Aid for Atrial Fibrillation in people with Atrial Fibrillation, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
The primary aim of this proposal is to determine the effectiveness of a decision support tool on improving the process of shared decision-making for treatment on nonvalvular atrial fibrillation (NVAF) compared to receipt of usual care. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Decision Aid for Atrial Fibrillation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jun 2010
- Phase
- Phase 1
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 45 years or older
- Be scheduled to see primary Doctor at VA
- Diagnosis of atrial fibrillation
- English speaking
Who cannot join
- Have valvular disease as the cause of Afib
- Be on warfarin for a condition other than NVAF
- Have a contraindication to warfin
- Have a contraindication to ASA
- Life expectancy of less than 12 months
- Cognitive impairment
Show all 13Show fewer
- Receiving anti-platelet agent other than aspirin
- Receiving care in a supervised resident clinic or from an attending physician who refuses participation in the study
- Bleed with identified source in the last 12 months
- Bleed with an unidentified source
- History of intracerebral hemorrhage
- Severe hearing impairment
- Severe visual impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System - West Haven Campus
West Haven, Connecticut, 06516
About this study
Official title: Improving Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making
The primary aim of this proposal is to determine the effectiveness of a decision support tool on improving the process of shared decision-making for treatment on nonvalvular atrial fibrillation (NVAF) compared to receipt of usual care.
Read the detailed description
Decision-making regarding appropriate therapy for non-valvular atrial fibrillation (NVAF) is a complex process. Different options carry with them different profiles of risks and benefits, and choosing the "right" therapy depends upon the patient's understanding of these risks and benefits and a consideration of the risks and benefits according to the patient's values and preferences. Studies have shown that patients' preferred therapy frequently disagrees with what is recommended by disease management guidelines.
The purpose of this study is to examine an intervention to improve the quality of decision-making for NVAF compared to usual care. The intervention has several components, including: a) educating the patient about why values and preferences are important to the decision-making process, b) providing an individualized assessment of the risks and benefits of each of the treatment options, c) exploring patients' values and preferences as they relate to the risks and benefits of each of the treatment options, d) preparing the patient to discuss his/her preferences with the physician.
- Conditions
- Atrial Fibrillation
- Being tested
- Decision Aid for Atrial Fibrillation, Usual Care
- Keywords
- Atrial fibrillation, Cerebrovascular accident, Anticoagulation, Decision-making
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision Aid for Atrial FibrillationBehavioural
Single contact educational session
Usual CareOther
Usual Care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Usual Care Receives: Other: Usual Care |
| 2 | Experimental | Intervention Receives: Behavioral: Decision Aid for Atrial Fibrillation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict
Measured: Immediately following and 1-month post-intervention
Secondary outcomes (4)
Knowledge regarding atrial fibrillation
Measured: Immediately following study intervention and 1 month post-intervention
Anxiety
Measured: Immediately following intervention and 1 month post-intervention
Changes in treatment plan for atrial fibrillation
Measured: Within 30 days post-intervention
Quality of clinician-patient communication
Measured: Clinician visit immediately post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2010
- Study completionJun 2010
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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- Donaghue Medical Research Foundation, Yale University
- Responsible party
- Sponsor
- Investigators
- Terri R Fried, M.D., Principal investigator, VA Connecticut HS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829478
- Sponsor's protocol ID
- Fried0011
- Acronym
- AFIB
- Status last verified
- Mar 2012
- First submitted
- 24 Jan 2009
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Quality of Care for Atrial Fibrillation by Promoting Patient-Centered Decision Making
- ClinicalTrials.gov ID
- NCT00829478
- Acronym / sponsor ID
- AFIB / Fried0011
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Cerebrovascular accident, Anticoagulation, Decision-making
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Collaborators
- Donaghue Medical Research Foundation, Yale University
- Study start
- Oct 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 Jan 2009 (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 primary aim of this proposal is to determine the effectiveness of a decision support tool on improving the process of shared decision-making for treatment on nonvalvular atrial fibrillation (NVAF) compared to receipt of usual care.
Detailed description
Decision-making regarding appropriate therapy for non-valvular atrial fibrillation (NVAF) is a complex process. Different options carry with them different profiles of risks and benefits, and choosing the "right" therapy depends upon the patient's understanding of these risks and benefits and a consideration of the risks and benefits according to the patient's values and preferences. Studies have shown that patients' preferred therapy frequently disagrees with what is recommended by disease management guidelines.
The purpose of this study is to examine an intervention to improve the quality of decision-making for NVAF compared to usual care. The intervention has several components, including: a) educating the patient about why values and preferences are important to the decision-making process, b) providing an individualized assessment of the risks and benefits of each of the treatment options, c) exploring patients' values and preferences as they relate to the risks and benefits of each of the treatment options, d) preparing the patient to discuss his/her preferences with the physician.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: Usual CareUsual Care |
| 2 | Experimental | Behavioral: Decision Aid for Atrial FibrillationIntervention |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 45 years or older
- Be scheduled to see primary Doctor at VA
- Diagnosis of atrial fibrillation
- English speaking
Key exclusion criteria (13 listed)
- Have valvular disease as the cause of Afib
- Be on warfarin for a condition other than NVAF
- Have a contraindication to warfin
- Have a contraindication to ASA
- Life expectancy of less than 12 months
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 |
|---|---|---|
| Decision Aid for Atrial FibrillationSingle contact educational session | Behavioural | 2 |
| Usual CareUsual Care | Other | 1 |
Primary outcome
Decisional conflict
Time frame: Immediately following and 1-month post-intervention
4 secondary outcomes
Knowledge regarding atrial fibrillation
Time frame: Immediately following study intervention and 1 month post-intervention
Anxiety
Time frame: Immediately following intervention and 1 month post-intervention
Changes in treatment plan for atrial fibrillation
Time frame: Within 30 days post-intervention
Quality of clinician-patient communication
Time frame: Clinician visit immediately post-intervention
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 20 Mar 2012.
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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.
Terri R Fried, M.D. principal investigator
VA Connecticut HS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Decision Aid for Atrial Fibrillation in people with Atrial Fibrillation, run by VA Connecticut Healthcare System 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 13 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 20 Mar 2012. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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?
Decisional conflict (time frame: Immediately following and 1-month post-intervention). 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 20 Mar 2012.