Atrial FibrillationNCT02745236
The Effect of Nurse Practitioner Led-Care on Quality of Life in Patients With Atrial Fibrillation
A study testing Nurse Practitioner Led-Care and Cardiologist Led-Care in people with Atrial Fibrillation, run by University of Alberta at 1 site in Canada.
Trial summary
Atrial fibrillation (AF) is the most common heart rhythm disease characterized by an irregular heart rhythm of the top part (atria) of the heart. It may cause unpleasant symptoms as well as increases the person's risk of stroke and heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Nurse Practitioner Led-Care and Cardiologist Led-Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jul 2016to 30 Nov 2020
- 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 years or older
- Documented non valvular atrial fibrillation
- Able to provide informed consent
- Able and willing to complete the study questionnaires on own or with assistance
Who cannot join
- Referral is for atrioventricular node ablation or pulmonary vein isolation.
- Patients who have failed antiarrhythmic medications
- Patients with moderate to severe mitral or aortic valvular heart disease
- Clinically unstable atrial fibrillation
- Cannot or unwilling to attend follow-up appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nurse Practitioner-Led Care on Health Related Quality Of Life in Adult Patients With Atrial Fibrillation - A Randomized Trial
Atrial fibrillation (AF) is the most common heart rhythm disease characterized by an irregular heart rhythm of the top part (atria) of the heart. It may cause unpleasant symptoms as well as increases the person's risk of stroke and heart failure. With an ageing population, increasing rates of AF and limited access to specialists, new methods of care, like nurse practitioners (NP) need to be assessed to meet patient specific needs and provide sustainable care.
The objective of the project is to evaluate the effect of Nurse Practitioner-led care in people with AF on their quality of life.
Read more
The Canadian Healthcare system is overwhelmed, with increasing costs and wait times. Contributing to these issues, is AF is the most common arrhythmia accompanied with costly complications including stroke and heart failure. Currently family or emergency room physicians ask general cardiologists or specialized cardiologists, to provide care to patients with AF. Unfortunately, there is limited access to their services. NP's are nurses who have taken extra education at University to treat patients and prescribe medications. This research project involves an NP who has specialized training in AF patient management.
By utilizing an NP to provide care for patients with AF, the investigators hope to improve patient's quality of life and satisfaction with care. This may also reduce complications of AF.
- Conditions
- Atrial Fibrillation
- Being tested
- Nurse Practitioner Led-Care, Cardiologist Led-Care
- Keywords
- Atrial Fibrillation, Health Related Quality of Life, Nurse Practitioner, Sustainable Models of Healthcare, Patient Satisfaction
- Medical subject headings
- Atrial Fibrillation, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Practitioner Led-CareOther
Also called Intervention Arm
Diagnosis and treatment plan decisions will be determined by Nurse Practitioner Led-Care.
Cardiologist Led-CareOther
Also called Control Arm
Diagnosis and treatment plan decisions will be determined as per usual care by the Cardiologist
| Study group | Role | What they receive |
|---|---|---|
| Nurse Practitioner Led-Care | Experimental | Nurse Practitioner (NP) Intervention Initial Visit and Interventions: An experienced nurse practitioner with extra atrial fibrillation (AF) management training will complete the initial assessment to determine a treatment plan based on current AF Guidelines. The NP will provide patient education on AF management.
Follow-up: Follow-up will occur at 3 and 6 months from baseline to evaluate the patient's response to treatment and will be modified as required based on AF symptoms, testing results and physical assessment.
A physician will be consulted for advanced specialty AF management or if a patient requires admission to hospital. Receives: Other: Nurse Practitioner Led-Care |
| Cardiologist Led-Care | Active comparator | Standard Care Initial Visit and Intervention: A general cardiologist will manage patients as per their usual practice.
Follow-up: As per the cardiologist's usual practice. The patient's care will remain with the family physician if no follow-up is required.
Follow-up: Follow-up will be determined as per the cardiologist's usual practice. If a follow-up appointment is required it will done in the cardiologist's own independent clinic. The patient's care will be referred back to the family physician if no follow-up is required. Receives: Other: Cardiologist Led-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups
Measured: At 6 months
Secondary outcomes (3)
Difference in change in EQ-5D scores between groups
Measured: At 6 months
Difference in composite outcomes of death from cardiovascular causes, cardiovascular hospitalization and emergency room visits between groups
Measured: At 6 months
Satisfaction with NP-led or cardiologist care as measured by the overall mean score of the Consultant Satisfaction Questionnaire (CSG).
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study start31 Jul 2016
- Primary completion1 Sep 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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 University of AlbertaThe 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Foundation
- Responsible party
- Principal investigator, Marcie Smigorowsky, University of Alberta
- Investigators
- Marcie J Smigorowsky, PhD, NP, Principal investigator, University of AlbertaRoss T Tsuyuki, PharmD, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02745236
- Sponsor's protocol ID
- MSmig01
- Status last verified
- Apr 2021
- First submitted
- 16 Apr 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cairns JA, Healey JS, Macle L, Mitchell LB, Verma A; Canadian Cardiovascular Society Atrial Fibrillation Guidelines Committee. The new Canadian Cardiovascular Society algorithm for antithrombotic therapy of atrial fibrillation is appropriately based on current epidemiologic data. Can J Cardiol. 2015 Jan;31(1):20-3. doi: 10.1016/j.cjca.2014.11.021. Epub 2014 Nov 26. No abstract available.
PubMed 25547545Verma A, Cairns JA, Mitchell LB, Macle L, Stiell IG, Gladstone D, McMurtry MS, Connolly S, Cox JL, Dorian P, Ivers N, Leblanc K, Nattel S, Healey JS; CCS Atrial Fibrillation Guidelines Committee. 2014 focused update of the Canadian Cardiovascular Society Guidelines for the management of atrial fibrillation. Can J Cardiol. 2014 Oct;30(10):1114-30. doi: 10.1016/j.cjca.2014.08.001. Epub 2014 Aug 13.
PubMed 25262857Faxon DP, Schwamm LH, Pasternak RC, Peterson ED, McNeil BJ, Bufalino V, Yancy CW, Brass LM, Baker DW, Bonow RO, Smaha LA, Jones DW, Smith SC Jr, Ellrodt G, Allen J, Schwartz SJ, Fonarow G, Duncan P, Horton K, Smith R, Stranne S, Shine K; American Heart Association's Expert Panel on Disease Management. Improving quality of care through disease management: principles and recommendations from the American Heart Association's Expert Panel on Disease Management. Circulation. 2004 Jun 1;109(21):2651-4. doi: 10.1161/01.CIR.0000128373.90851.7B. No abstract available.
PubMed 15173048Campbell DJ, Sargious P, Lewanczuk R, McBrien K, Tonelli M, Hemmelgarn B, Manns B. Use of chronic disease management programs for diabetes: in Alberta's primary care networks. Can Fam Physician. 2013 Feb;59(2):e86-92.
PubMed 23418263Gillis AM, Burland L, Arnburg B, Kmet C, Pollak PT, Kavanagh K, Veenhuyzen G, Wyse DG. Treating the right patient at the right time: an innovative approach to the management of atrial fibrillation. Can J Cardiol. 2008 Mar;24(3):195-8. doi: 10.1016/s0828-282x(08)70583-x.
PubMed 18340388Ross H, Higginson LA, Ferguson A, O'Neill BJ, Kells CM, Cox JL, Sholdice MM. Too many patients, too few cardiologists to care? Can J Cardiol. 2006 Sep;22(11):901-2. doi: 10.1016/s0828-282x(06)70308-7. No abstract available.
PubMed 17016884Kinnersley P, Anderson E, Parry K, Clement J, Archard L, Turton P, Stainthorpe A, Fraser A, Butler CC, Rogers C. Randomised controlled trial of nurse practitioner versus general practitioner care for patients requesting "same day" consultations in primary care. BMJ. 2000 Apr 15;320(7241):1043-8. doi: 10.1136/bmj.320.7241.1043.
PubMed 10764366Seale C, Anderson E, Kinnersley P. Comparison of GP and nurse practitioner consultations: an observational study. Br J Gen Pract. 2005 Dec;55(521):938-43.
PubMed 16378563Thrasher C, Purc-Stephenson R. Patient satisfaction with nurse practitioner care in emergency departments in Canada. J Am Acad Nurse Pract. 2008 May;20(5):231-7. doi: 10.1111/j.1745-7599.2008.00312.x.
PubMed 18460162Oliver GM, Pennington L, Revelle S, Rantz M. Impact of nurse practitioners on health outcomes of Medicare and Medicaid patients. Nurs Outlook. 2014 Nov-Dec;62(6):440-7. doi: 10.1016/j.outlook.2014.07.004. Epub 2014 Aug 1.
PubMed 25172368Hendriks JM, de Wit R, Crijns HJ, Vrijhoef HJ, Prins MH, Pisters R, Pison LA, Blaauw Y, Tieleman RG. Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. Eur Heart J. 2012 Nov;33(21):2692-9. doi: 10.1093/eurheartj/ehs071. Epub 2012 Mar 27.
PubMed 22453654Johnston BC, Patrick DL, Busse JW, Schunemann HJ, Agarwal A, Guyatt GH. Patient-reported outcomes in meta-analyses--Part 1: assessing risk of bias and combining outcomes. Health Qual Life Outcomes. 2013 Jul 1;11:109. doi: 10.1186/1477-7525-11-109.
PubMed 23815754Spertus J, Dorian P, Bubien R, Lewis S, Godejohn D, Reynolds MR, Lakkireddy DR, Wimmer AP, Bhandari A, Burk C. Development and validation of the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire in patients with atrial fibrillation. Circ Arrhythm Electrophysiol. 2011 Feb;4(1):15-25. doi: 10.1161/CIRCEP.110.958033. Epub 2010 Dec 15.
PubMed 21160035Dorian P, Cvitkovic SS, Kerr CR, Crystal E, Gillis AM, Guerra PG, Mitchell LB, Roy D, Skanes AC, Wyse DG. A novel, simple scale for assessing the symptom severity of atrial fibrillation at the bedside: the CCS-SAF scale. Can J Cardiol. 2006 Apr;22(5):383-6. doi: 10.1016/s0828-282x(06)70922-9.
PubMed 16639472Dorian P, Guerra PG, Kerr CR, O'Donnell SS, Crystal E, Gillis AM, Mitchell LB, Roy D, Skanes AC, Rose MS, Wyse DG. Validation of a new simple scale to measure symptoms in atrial fibrillation: the Canadian Cardiovascular Society Severity in Atrial Fibrillation scale. Circ Arrhythm Electrophysiol. 2009 Jun;2(3):218-24. doi: 10.1161/CIRCEP.108.812347. Epub 2009 Mar 31.
PubMed 19808471
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nurse Practitioner-Led Care on Health Related Quality Of Life in Adult Patients With Atrial Fibrillation - A Randomized Trial
- ClinicalTrials.gov ID
- NCT02745236
- Acronym / sponsor ID
- MSmig01
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Health Related Quality of Life, Nurse Practitioner, Sustainable Models of Healthcare, Patient Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University Hospital Foundation
- Study start
- 31 Jul 2016 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 20 Apr 2016 (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.
Atrial fibrillation (AF) is the most common heart rhythm disease characterized by an irregular heart rhythm of the top part (atria) of the heart. It may cause unpleasant symptoms as well as increases the person's risk of stroke and heart failure. With an ageing population, increasing rates of AF and limited access to specialists, new methods of care, like nurse practitioners (NP) need to be assessed to meet patient specific needs and provide sustainable care.
The objective of the project is to evaluate the effect of Nurse Practitioner-led care in people with AF on their quality of life.
The Canadian Healthcare system is overwhelmed, with increasing costs and wait times. Contributing to these issues, is AF is the most common arrhythmia accompanied with costly complications including stroke and heart failure. Currently family or emergency room physicians ask general cardiologists or specialized cardiologists, to provide care to patients with AF. Unfortunately, there is limited access to their services. NP's are nurses who have taken extra education at University to treat patients and prescribe medications. This research project involves an NP who has specialized training in AF patient management.
By utilizing an NP to provide care for patients with AF, the investigators hope to improve patient's quality of life and satisfaction with care. This may also reduce complications of AF.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Practitioner Led-Care | Experimental | Other: Nurse Practitioner Led-CareNurse Practitioner (NP) Intervention Initial Visit and Interventions: An experienced nurse practitioner with extra atrial fibrillation (AF) management training will complete the initial assessment to determine a treatment plan based on current AF Guidelines. The NP will provide patient education on AF management. Follow-up: Follow-up will occur at 3 and 6 months from baseline to evaluate the patient's response to treatment and will be modified as required based on AF symptoms, testing results and physical assessment. A physician will be consulted for advanced specialty AF management or if a patient requires admission to hospital. |
| Cardiologist Led-Care | Active comparator | Other: Cardiologist Led-CareStandard Care Initial Visit and Intervention: A general cardiologist will manage patients as per their usual practice. Follow-up: As per the cardiologist's usual practice. The patient's care will remain with the family physician if no follow-up is required. Follow-up: Follow-up will be determined as per the cardiologist's usual practice. If a follow-up appointment is required it will done in the cardiologist's own independent clinic. The patient's care will be referred back to the family physician if no follow-up is required. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Documented non valvular atrial fibrillation
- Able to provide informed consent
- Able and willing to complete the study questionnaires on own or with assistance
Key exclusion criteria (5 listed)
- Referral is for atrioventricular node ablation or pulmonary vein isolation.
- Patients who have failed antiarrhythmic medications
- Patients with moderate to severe mitral or aortic valvular heart disease
- Clinically unstable atrial fibrillation
- Cannot or unwilling to attend follow-up appointments
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 |
|---|---|---|
| Nurse Practitioner Led-CareAlso: Intervention ArmDiagnosis and treatment plan decisions will be determined by Nurse Practitioner Led-Care. | Other | Nurse Practitioner Led-Care |
| Cardiologist Led-CareAlso: Control ArmDiagnosis and treatment plan decisions will be determined as per usual care by the Cardiologist | Other | Cardiologist Led-Care |
Primary outcome
Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups
Time frame: At 6 months
3 secondary outcomes
Difference in change in EQ-5D scores between groups
Time frame: At 6 months
Difference in composite outcomes of death from cardiovascular causes, cardiovascular hospitalization and emergency room visits between groups
Time frame: At 6 months
Satisfaction with NP-led or cardiologist care as measured by the overall mean score of the Consultant Satisfaction Questionnaire (CSG).
Time frame: At 6 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 28 Apr 2021.
- Background: PubMed 25547545Cairns JA, Healey JS, Macle L, Mitchell LB, Verma A; Canadian Cardiovascular Society Atrial Fibrillation Guidelines Committee. The new Canadian Cardiovascular Society algorithm for antithrombotic therapy of atrial fibrillation is appropriately based on current epidemiologic data. Can J Cardiol. 2015 Jan;31(1):20-3. doi: 10.1016/j.cjca.2014.11.021. Epub 2014 Nov 26. No abstract available.
- Background: PubMed 25262857Verma A, Cairns JA, Mitchell LB, Macle L, Stiell IG, Gladstone D, McMurtry MS, Connolly S, Cox JL, Dorian P, Ivers N, Leblanc K, Nattel S, Healey JS; CCS Atrial Fibrillation Guidelines Committee. 2014 focused update of the Canadian Cardiovascular Society Guidelines for the management of atrial fibrillation. Can J Cardiol. 2014 Oct;30(10):1114-30. doi: 10.1016/j.cjca.2014.08.001. Epub 2014 Aug 13.
- Background: PubMed 15173048Faxon DP, Schwamm LH, Pasternak RC, Peterson ED, McNeil BJ, Bufalino V, Yancy CW, Brass LM, Baker DW, Bonow RO, Smaha LA, Jones DW, Smith SC Jr, Ellrodt G, Allen J, Schwartz SJ, Fonarow G, Duncan P, Horton K, Smith R, Stranne S, Shine K; American Heart Association's Expert Panel on Disease Management. Improving quality of care through disease management: principles and recommendations from the American Heart Association's Expert Panel on Disease Management. Circulation. 2004 Jun 1;109(21):2651-4. doi: 10.1161/01.CIR.0000128373.90851.7B. No abstract available.
- Background: PubMed 23418263Campbell DJ, Sargious P, Lewanczuk R, McBrien K, Tonelli M, Hemmelgarn B, Manns B. Use of chronic disease management programs for diabetes: in Alberta's primary care networks. Can Fam Physician. 2013 Feb;59(2):e86-92.
- Background: PubMed 18340388Gillis AM, Burland L, Arnburg B, Kmet C, Pollak PT, Kavanagh K, Veenhuyzen G, Wyse DG. Treating the right patient at the right time: an innovative approach to the management of atrial fibrillation. Can J Cardiol. 2008 Mar;24(3):195-8. doi: 10.1016/s0828-282x(08)70583-x.
- Background: PubMed 17016884Ross H, Higginson LA, Ferguson A, O'Neill BJ, Kells CM, Cox JL, Sholdice MM. Too many patients, too few cardiologists to care? Can J Cardiol. 2006 Sep;22(11):901-2. doi: 10.1016/s0828-282x(06)70308-7. No abstract available.
- Background: PubMed 10764366Kinnersley P, Anderson E, Parry K, Clement J, Archard L, Turton P, Stainthorpe A, Fraser A, Butler CC, Rogers C. Randomised controlled trial of nurse practitioner versus general practitioner care for patients requesting "same day" consultations in primary care. BMJ. 2000 Apr 15;320(7241):1043-8. doi: 10.1136/bmj.320.7241.1043.
- Background: PubMed 16378563Seale C, Anderson E, Kinnersley P. Comparison of GP and nurse practitioner consultations: an observational study. Br J Gen Pract. 2005 Dec;55(521):938-43.
- Background: PubMed 18460162Thrasher C, Purc-Stephenson R. Patient satisfaction with nurse practitioner care in emergency departments in Canada. J Am Acad Nurse Pract. 2008 May;20(5):231-7. doi: 10.1111/j.1745-7599.2008.00312.x.
- Background: PubMed 25172368Oliver GM, Pennington L, Revelle S, Rantz M. Impact of nurse practitioners on health outcomes of Medicare and Medicaid patients. Nurs Outlook. 2014 Nov-Dec;62(6):440-7. doi: 10.1016/j.outlook.2014.07.004. Epub 2014 Aug 1.
- Background: PubMed 22453654Hendriks JM, de Wit R, Crijns HJ, Vrijhoef HJ, Prins MH, Pisters R, Pison LA, Blaauw Y, Tieleman RG. Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation. Eur Heart J. 2012 Nov;33(21):2692-9. doi: 10.1093/eurheartj/ehs071. Epub 2012 Mar 27.
- Background: PubMed 23815754Johnston BC, Patrick DL, Busse JW, Schunemann HJ, Agarwal A, Guyatt GH. Patient-reported outcomes in meta-analyses--Part 1: assessing risk of bias and combining outcomes. Health Qual Life Outcomes. 2013 Jul 1;11:109. doi: 10.1186/1477-7525-11-109.
- Individual participant dataSharing planned: Undecided
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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.
Marcie J Smigorowsky, PhD, NP principal investigator
University of Alberta
Ross T Tsuyuki, PharmD, MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Practitioner Led-Care and Cardiologist Led-Care in people with Atrial Fibrillation, run by University of Alberta at 1 site in Canada.
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 5 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 28 Apr 2021. 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 Canada. 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?
Difference in change in Atrial Fibrillation Effect on Quality of Life (AFEQT) scores between groups (time frame: At 6 months). 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 NCT02745236, which also lists 21 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 28 Apr 2021.