Atrial FibrillationENHANCE-AFNCT04096781
Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
A study testing SDMT in people with Atrial Fibrillation and Atrial Flutter, run by Stanford University at 5 sites in United States.
Trial summary
A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter, Stroke
- What is being tested?
- SDMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,001 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Dec 2019to 17 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 y/o
- Non-valvular atrial fibrillation or atrial flutter (AFib)
- CHA2DS2-VASc stroke score of:
- Men: 1 or more
- Women: 2 or more
- Able to consent in English or Spanish (if resources allow) and follow study instructions
Who cannot join
- Moderate to severe mitral stenosis
- Mechanical valve replacement
- Absolute contraindication to anticoagulation (Based on clinician judgment)
- Indication for anticoagulation therapy for a condition other than atrial fibrillation
- Left atrial appendage exclusion (by surgery or device placement)
- At the clinical discretion of the investigator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cooper University Hospital
Camden, New Jersey, 08103
Cleveland Clinic Foundation
Cleveland, Ohio, 931562
East Carolina University
Greenville, North Carolina, 27858
Ochsner Medical Center
New Orleans, Louisiana, 70121
Stanford University
Palo Alto, California, 94305
About this study
A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention
Read the detailed description
This study will test to see if a new type of decision-making process tool, called a Shared Decision Making Pathway, can make a difference in decreasing the risk of stroke due to a condition called Atrial Fibrillation (AFib.) This online tool is designed to help doctors and patients decide together on treatment options for AFib.
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Cardiac, Heart Failure, Arrhythmia
- Being tested
- SDMT, Usual Care
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Stroke, Heart Failure, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDMTBehavioural
The intervention involves a clear pathway centered on the use of a web-based decision tool. This tool aims to support the shared decision-making process for anticoagulation for stroke prevention in atrial fibrillation. This web-based tool will be used both by the participants as well the physician responsible for atrial fibrillation decision making.
Usual CareBehavioural
The participants will receive usual care.
| Study group | Role | What they receive |
|---|---|---|
| Shared Decision Making Tool (SDMT) | Experimental | Not described Receives: Behavioral: SDMT |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale
The Decisional Conflict Scale is a 16 Item scale on whether the participants have enough information to make a clear decision. Each item scored from 1-5, where 1 indicates clarity and 5 indicates confusion, with total score ranging from 16-80
Measured: Visit 2 (1-month follow-up)
Secondary outcomes (15)
Decisional Conflict Scale (16 items)
The Decisional Conflict Scale is a 16 Item scale on whether the participants have enough information to make a clear decision. Each item scored from 1-5, where 1 indicates clarity and 5 indicates confusion, with total score ranging from 16-80
Measured: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Decision Regret Scale (5 items)
Decision Regret Scale, is scored from 1-5, where 1 indicates they made the right decision and 5 indicates they made the wrong decision. This scale ranges from 5-25
Measured: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Weighted composite outcome scale according to patient preference
Patient-selected weighted composite outcome scale is a composite scale to consider both decisional conflict and decisional regret scales simultaneously according to the priority based on the survey of 100 potential participants. The rationale for this endpoint is to consider not only the preference of majority patients (73%) but also the minority (27%) participants who prefer the decisional regret scale
Measured: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Preparation for Decision Making Scale (10 items)
Preparation for Decision Making scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision
Measured: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Utah-Stanford Atrial Fibrillation Knowledge Assessment
Newly developed assessment for this study to record Atrial Fibrillation Knowledge
Measured: Baseline, Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Quality of Communication (Based on CAHPS Clinician & Group Survey)
CAHPS 3-item modified version
Measured: Visit 1 (Post Clinic Visit)
Atrial Fibrillation Severity Scale (AFSS)
The University of Toronto Atrial Fibrillation Severity Scale (AFSS) is a questionnaire designed for patients with AFib. It consists of 19 items combined into 3 parts to capture total AF burden, health care utilization, and the severity of AFib related symptoms
Measured: Baseline, Visit 2 (1-month follow up), Visit 3(6-month follow-up)
Collaborative Agreement on Decision
Assess the collaborative agreement (1. Patient Reported Outcome 2) Clinician Reported
Measured: Visit 1 (Post Clinic Visit)
Clinician Satisfaction of the Decision Aid: Physician Survey
Clinician Satisfaction of the Decision Aid as assessed by a physician survey on shared decision making
Measured: Visit 1 (Post Clinic Visit)
Patient Satisfaction of the Decision Aid: Patient Survey
Patient Satisfaction of the Decision Aid as assessed by Patient survey on shared decision making
Measured: Visit 1 (Post Clinic Visit)
Length of Visit at visit 1 (clinician)
Compare treatment arm on the length of visit
Measured: Visit 1 (Post Clinic Visit)
Anticoagulant Choice (Patient follow up questions on Anticoagulant use)
Decision on anticoagulation choice as assessed by patient follow up questions
Measured: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Anticoagulation Persistence and adherence (Patient follow up questions on Anticoagulant use)
Persistence and adherence to anticoagulation among participants selecting anticoagulation, as assessed by Patient follow up questions
Measured: Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus
Incidence of Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus
Measured: Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled
Death
Incidence of Death
Measured: Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start18 Dec 2019
- Primary completion23 Jun 2022
- Study completion17 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Shared Decision-Making pathway focused on a digital shared decision-making tool (SDMT) that is augmented by a clinician tool and an optional lay coach
- Masking
- None (open label)
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, East Carolina University, Ochsner Health System, The Cleveland Clinic, Cooper Norcross Health
- Responsible party
- Principal investigator, Paul Wang, Stanford University
- Investigators
- Paul J Wang, MD, Principal investigator, Stanford UniversityRandall S Stafford, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096781
- Sponsor's protocol ID
- 50864
- Acronym
- ENHANCE-AF
- Status last verified
- Apr 2024
- First submitted
- 9 Sep 2019
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baykaner T, Pundi K, Lin B, Lu Y, DeSutter K, Lhamo K, Garay G, Nunes JC, Morin DP, Sears SF, Chung MK, Paasche-Orlow MK, Sanders LM, Bunch TJ, Hills MT, Mahaffey KW, Stafford RS, Wang PJ. The ENHANCE-AF clinical trial to evaluate an atrial fibrillation shared decision-making pathway: Rationale and study design. Am Heart J. 2022 May;247:68-75. doi: 10.1016/j.ahj.2022.01.013. Epub 2022 Jan 28.
PubMed 35092723Nunes JC, Baykaner T, Pundi K, DeSutter K, True Hills M, Mahaffey KW, Sears SF, Morin DP, Lin B, Wang PJ, Stafford RS. Design and development of a digital shared decision-making tool for stroke prevention in atrial fibrillation. JAMIA Open. 2023 Feb 2;6(1):ooad003. doi: 10.1093/jamiaopen/ooad003. eCollection 2023 Apr.
PubMed 36751465Chung MK, Fagerlin A, Wang PJ, Ajayi TB, Allen LA, Baykaner T, Benjamin EJ, Branda M, Cavanaugh KL, Chen LY, Crossley GH, Delaney RK, Eckhardt LL, Grady KL, Hargraves IG, True Hills M, Kalscheur MM, Kramer DB, Kunneman M, Lampert R, Langford AT, Lewis KB, Lu Y, Mandrola JM, Martinez K, Matlock DD, McCarthy SR, Montori VM, Noseworthy PA, Orland KM, Ozanne E, Passman R, Pundi K, Roden DM, Saarel EV, Schmidt MM, Sears SF, Stacey D, Stafford RS, Steinberg BA, Youn Wass S, Wright JM. Shared Decision Making in Cardiac Electrophysiology Procedures and Arrhythmia Management. Circ Arrhythm Electrophysiol. 2021 Dec;14(12):e007958. doi: 10.1161/CIRCEP.121.007958. Epub 2021 Dec 6.
PubMed 34865518Pundi K, Baykaner T, True Hills M, Lin B, Morin DP, Sears SF, Wang PJ, Stafford RS. Blood Thinners for Atrial Fibrillation Stroke Prevention. Circ Arrhythm Electrophysiol. 2021 Jun;14(6):e009389. doi: 10.1161/CIRCEP.120.009389. Epub 2021 Jun 11. No abstract available.
PubMed 34111936Ajayi TB, Remein CD, Stafford RS, Fagerlin A, Chung MK, Childs E, Benjamin EJ. Cross-Center Virtual Education Fellowship Program for Early-Career Researchers in Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008552. doi: 10.1161/CIRCEP.120.008552. Epub 2020 Oct 8.
PubMed 33031707Nunes, J.C., Shah, S., Fazal, M. et al. Patient Education Strategies to Improve Risk of Stroke in Patients with Atrial Fibrillation. Curr Cardiovasc Risk Rep 16, 249-258 (2022). https://doi.org/10.1007/s12170-022-00709-8.
Pourshams I, Lin B, Wang PJ, Stafford RS. Decision-Making Experiences and Decisional Regret in Patients Receiving Implanted Cardioverter-Defibrillators. Heart Mind 2022; 6(1): 32-5. doi: 10.4103/hm.hm_51_21
Wang PJ, Lu Y, Mahaffey KW, Lin A, Morin DP, Sears SF, Chung MK, Russo AM, Lin B, Piccini J, Hills MT, Berube C, Pundi K, Baykaner T, Garay G, Lhamo K, Rice E, Pourshams IA, Shah R, Newswanger P, DeSutter K, Nunes JC, Albert MA, Schulman KA, Heidenreich PA, Bunch TJ, Sanders LM, Turakhia M, Verghese A, Stafford RS. Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway. J Am Heart Assoc. 2023 Feb 7;12(3):e028562. doi: 10.1161/JAHA.122.028562. Epub 2023 Feb 7.
PubMed 36342828
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
- ClinicalTrials.gov ID
- NCT04096781
- Acronym / sponsor ID
- ENHANCE-AF / 50864
- Conditions
- Atrial Fibrillation, Atrial Flutter, Stroke, Cardiac, Heart Failure, Arrhythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- American Heart Association, East Carolina University, Ochsner Health System, The Cleveland Clinic, Cooper Norcross Health
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 23 Jun 2022 (actual)
- Study completion
- 17 Aug 2022 (actual)
- First posted
- 20 Sep 2019 (actual)
- 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.
A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention
Detailed description
This study will test to see if a new type of decision-making process tool, called a Shared Decision Making Pathway, can make a difference in decreasing the risk of stroke due to a condition called Atrial Fibrillation (AFib.) This online tool is designed to help doctors and patients decide together on treatment options for AFib.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Shared Decision-Making pathway focused on a digital shared decision-making tool (SDMT) that is augmented by a clinician tool and an optional lay coach
| Arm | Type | Receives |
|---|---|---|
| Shared Decision Making Tool (SDMT) | Experimental | Behavioral: SDMT |
| Usual Care | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 y/o
- Non-valvular atrial fibrillation or atrial flutter (AFib)
- CHA2DS2-VASc stroke score of:
- Able to consent in English or Spanish (if resources allow) and follow study instructions
Key exclusion criteria (6 listed)
- Moderate to severe mitral stenosis
- Mechanical valve replacement
- Absolute contraindication to anticoagulation (Based on clinician judgment)
- Indication for anticoagulation therapy for a condition other than atrial fibrillation
- Left atrial appendage exclusion (by surgery or device placement)
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 |
|---|---|---|
| SDMTThe intervention involves a clear pathway centered on the use of a web-based decision tool. This tool aims to support the shared decision-making process for anticoagulation for stroke prevention in atrial fibrillation. This web-based tool will be used both by the participants as well the physician responsible for atrial fibrillation decision making. | Behavioural | Shared Decision Making Tool (SDMT) |
| Usual CareThe participants will receive usual care. | Behavioural | Usual Care |
Primary outcome
Decisional Conflict Scale
Time frame: Visit 2 (1-month follow-up)
The Decisional Conflict Scale is a 16 Item scale on whether the participants have enough information to make a clear decision. Each item scored from 1-5, where 1 indicates clarity and 5 indicates confusion, with total score ranging from 16-80
15 secondary outcomes
Decisional Conflict Scale (16 items)
Time frame: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Decision Regret Scale (5 items)
Time frame: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Weighted composite outcome scale according to patient preference
Time frame: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Preparation for Decision Making Scale (10 items)
Time frame: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Utah-Stanford Atrial Fibrillation Knowledge Assessment
Time frame: Baseline, Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Quality of Communication (Based on CAHPS Clinician & Group Survey)
Time frame: Visit 1 (Post Clinic Visit)
Atrial Fibrillation Severity Scale (AFSS)
Time frame: Baseline, Visit 2 (1-month follow up), Visit 3(6-month follow-up)
Collaborative Agreement on Decision
Time frame: Visit 1 (Post Clinic Visit)
Clinician Satisfaction of the Decision Aid: Physician Survey
Time frame: Visit 1 (Post Clinic Visit)
Patient Satisfaction of the Decision Aid: Patient Survey
Time frame: Visit 1 (Post Clinic Visit)
Length of Visit at visit 1 (clinician)
Time frame: Visit 1 (Post Clinic Visit)
Anticoagulant Choice (Patient follow up questions on Anticoagulant use)
Time frame: Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Anticoagulation Persistence and adherence (Patient follow up questions on Anticoagulant use)
Time frame: Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus
Time frame: Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled
Death
Time frame: Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled
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 5 Apr 2024.
- Background: PubMed 35092723Baykaner T, Pundi K, Lin B, Lu Y, DeSutter K, Lhamo K, Garay G, Nunes JC, Morin DP, Sears SF, Chung MK, Paasche-Orlow MK, Sanders LM, Bunch TJ, Hills MT, Mahaffey KW, Stafford RS, Wang PJ. The ENHANCE-AF clinical trial to evaluate an atrial fibrillation shared decision-making pathway: Rationale and study design. Am Heart J. 2022 May;247:68-75. doi: 10.1016/j.ahj.2022.01.013. Epub 2022 Jan 28.
- Background: PubMed 36751465Nunes JC, Baykaner T, Pundi K, DeSutter K, True Hills M, Mahaffey KW, Sears SF, Morin DP, Lin B, Wang PJ, Stafford RS. Design and development of a digital shared decision-making tool for stroke prevention in atrial fibrillation. JAMIA Open. 2023 Feb 2;6(1):ooad003. doi: 10.1093/jamiaopen/ooad003. eCollection 2023 Apr.
- Background: PubMed 34865518Chung MK, Fagerlin A, Wang PJ, Ajayi TB, Allen LA, Baykaner T, Benjamin EJ, Branda M, Cavanaugh KL, Chen LY, Crossley GH, Delaney RK, Eckhardt LL, Grady KL, Hargraves IG, True Hills M, Kalscheur MM, Kramer DB, Kunneman M, Lampert R, Langford AT, Lewis KB, Lu Y, Mandrola JM, Martinez K, Matlock DD, McCarthy SR, Montori VM, Noseworthy PA, Orland KM, Ozanne E, Passman R, Pundi K, Roden DM, Saarel EV, Schmidt MM, Sears SF, Stacey D, Stafford RS, Steinberg BA, Youn Wass S, Wright JM. Shared Decision Making in Cardiac Electrophysiology Procedures and Arrhythmia Management. Circ Arrhythm Electrophysiol. 2021 Dec;14(12):e007958. doi: 10.1161/CIRCEP.121.007958. Epub 2021 Dec 6.
- Background: PubMed 34111936Pundi K, Baykaner T, True Hills M, Lin B, Morin DP, Sears SF, Wang PJ, Stafford RS. Blood Thinners for Atrial Fibrillation Stroke Prevention. Circ Arrhythm Electrophysiol. 2021 Jun;14(6):e009389. doi: 10.1161/CIRCEP.120.009389. Epub 2021 Jun 11. No abstract available.
- Background: PubMed 33031707Ajayi TB, Remein CD, Stafford RS, Fagerlin A, Chung MK, Childs E, Benjamin EJ. Cross-Center Virtual Education Fellowship Program for Early-Career Researchers in Atrial Fibrillation. Circ Arrhythm Electrophysiol. 2020 Nov;13(11):e008552. doi: 10.1161/CIRCEP.120.008552. Epub 2020 Oct 8.
- BackgroundNunes, J.C., Shah, S., Fazal, M. et al. Patient Education Strategies to Improve Risk of Stroke in Patients with Atrial Fibrillation. Curr Cardiovasc Risk Rep 16, 249-258 (2022). https://doi.org/10.1007/s12170-022-00709-8.
- BackgroundPourshams I, Lin B, Wang PJ, Stafford RS. Decision-Making Experiences and Decisional Regret in Patients Receiving Implanted Cardioverter-Defibrillators. Heart Mind 2022; 6(1): 32-5. doi: 10.4103/hm.hm_51_21
- Results publication: PubMed 36342828Wang PJ, Lu Y, Mahaffey KW, Lin A, Morin DP, Sears SF, Chung MK, Russo AM, Lin B, Piccini J, Hills MT, Berube C, Pundi K, Baykaner T, Garay G, Lhamo K, Rice E, Pourshams IA, Shah R, Newswanger P, DeSutter K, Nunes JC, Albert MA, Schulman KA, Heidenreich PA, Bunch TJ, Sanders LM, Turakhia M, Verghese A, Stafford RS. Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway. J Am Heart Assoc. 2023 Feb 7;12(3):e028562. doi: 10.1161/JAHA.122.028562. Epub 2023 Feb 7.
- Individual participant dataSharing planned: No
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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.
Paul J Wang, MD principal investigator
Stanford University
Randall S Stafford, MD principal investigator
Stanford University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SDMT in people with Atrial Fibrillation and Atrial Flutter, run by Stanford University at 5 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 6 inclusion and 6 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 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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 Scale (time frame: Visit 2 (1-month follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04096781, which also lists 8 linked publications.
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 5 Apr 2024.