Cardiovascular Risk Reduction of Having a Coronary EventANCHORNCT01620996
A Novel Approach to Cardiovascular Health by Optimizing Risk Management (ANCHOR)
A study testing Minimal Intervention, Motivational Interviewing and Motivational Enhancement in people with Cardiovascular Risk Reduction of Having a Coronary Event, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Study Purpose and Design The goal of this study is to improve CVD risk in a primary care adult population, with the following primary objectives 1. To improve management of global cardiovascular risk of patients within two primary care practices, thereby improving their overall cardiac health. 2. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Reduction of Having a Coronary Event
- What is being tested?
- Minimal Intervention, Motivational Interviewing and Motivational Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,708 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2006to Sep 2010
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 30 years of age
- a patient of the primary care practices involved in the study
- able to provide informed consent
Who cannot join
- under the age of 30
- not a patient of the primary care practices
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Approach to Cardiovascular Health by Optimizing Risk Management (ANCHOR): A Primary Prevention Initiative Examining The Impact Of Global Risk Factor Assessment & Management On Health Care In Nova Scotia
Study Purpose and Design
The goal of this study is to improve CVD risk in a primary care adult population, with the following primary objectives
Read more
- To improve management of global cardiovascular risk of patients within two primary care practices, thereby improving their overall cardiac health.
- To increase patient compliance with lifestyle aimed at pharmaceutical interventions aimed at decreasing global cardiovascular risk.
Secondary objectives of the study are:
- To examine the utility of a process to improve the management of global cardiovascular risk of patients within two primary care practices.
- To explore the utility of a process that links primary care practices with existing community resources in order to manage cardiac risk factors better among individuals within those primary care practices.
- To determine the economic impact of a global risk assessment and management process within a primary care setting.
Read the detailed description
The Burden of Cardiovascular Disease
Cardiovascular disease (CVD) remains the major cause of mortality in the developed world, accounting for almost 40% of all deaths in both the United States and Canada. It represents a substantial financial drain on society and contributes a significant burden to health care systems that are already under strain. Major modifiable risk factors for CVD include elevated blood pressure, cigarette smoking, elevated total plasma cholesterol and low high-density lipoproteins, diabetes, obesity, and sedentary lifestyle, at least one of which is present in 80% of Canadians. Circulatory diseases (particularly heart disease, stroke and hypertension) cost the Nova Scotia health care system an estimated $961 million dollars per year. In Nova Scotia cardiovascular disease kills an estimated 2,900 Nova Scotians every year accounting for nearly 36% of all deaths in the province.
Cardiovascular Disease Prevention in Primary Care Settings
There is strong evidence linking improved risk factors among populations to improved health outcomes, and both epidemiological and community research have illustrated that the bulk of non-communicable diseases (NCDs) such as CVD are preventable, or at least their occurrence can be postponed. Because primary care physicians are most often the first point of contact for individuals in need of health care, general practice is well placed to facilitate change in patients' risk factor status and ensure more effective treatment of risk factors such as hypertension and hyperlipidemia. Currently primary care service delivery is expanding to include a broader network of providers such as nurses, dieticians, and pharmacists to enable more effective risk factor identification and management, and health promotion and disease prevention efforts across the continuum of care.
Nova Scotia Context
Currently in Nova Scotia, population health and disease prevention initiatives are underway that will support and reinforce the work of the current study, including primary health care transition fund initiatives, and strategic directions from the Office of Health Promotion that address major risk factors for cardiovascular disease. These provincial initiatives together with local projects ongoing in several communities provide an ideal opportunity for interfacing with a primary care global risk reduction initiative.
Study Purpose and Design
The goal of this study is to improve CVD risk in a primary care adult population, with the following primary objectives
- To improve management of global cardiovascular risk of patients within two primary care practices, thereby improving their overall cardiac health.
- To increase patient compliance with lifestyle and pharmaceutical interventions aimed at decreasing global cardiovascular risk.
Secondary objectives of the study are:
- To examine the utility of a process to improve the management of global cardiovascular risk of patients within two primary care practices.
- To explore the utility of a process that links primary care practices with existing community resources in order to manage cardiac risk factors better among individuals within those primary care practices.
- To determine the economic impact of a global risk assessment and management process within a primary care setting.
The intervention will be led by a study coordinator in each primary care setting and consist of a recruitment strategy, global risk factor assessment, behaviour change counseling, and risk factor management strategies based on the 5A's framework (assess, advise, agree, assist and arrange follow-up). Supports will be provided to study participants in making behaviour changes including counseling and follow-up, behaviour change tools, print resources, group education sessions, and an inventory of and links to community programs. Medication reviews and physician referrals will also be completed as required.
A Steering Committee will guide the project and includes membership from the Principal Investigators, representatives from Pfizer Canada, Capital District Health Authority, the Cape Breton District Health Authority and the Nova Scotia Department of Health; and community stakeholders including community pharmacy, a physician and/or nurse from each site, other relevant allied health professionals (e.g., nutritionist) and the CEO from the Heart and Stroke Foundation of Nova Scotia. The initiative will be conducted over a three-year period and will comprise three phases as outlined in the following table.
Research Methodology
This is a pre-intervention and post-intervention longitudinal, prospective pilot study to evaluate study participants achievement of CVD risk factor reduction. The research will include a combination of quantitative and qualitative data to judge effectiveness of the interventions and to describe the intervention as it is implemented. The effectiveness of the approach will be examined using pre and post measures of key outcome variables. In addition to these outcome measures, process evaluation will monitor and assess the implementation of the interventions. The study will include baselines measurement, periodic assessments of process measures, outcome measurement and follow-up measurement. Following the baseline measurement through the GRA, patients will receive risk management interventions.
The data will be analyzed using both quantitative and qualitative methods. Pre and post outcome measures will be analyzed using descriptive analytical techniques comparing means for continuous measures and proportions for categorical measures. Qualitative data will be managed and analyzed either manually or via QSR NUD*IST (Qualitative Solutions and Research Non-numerical Unstructured Data Indexing Searching and Theory-building) software. The qualitative analysis will consist of both content and thematic analysis.
Sustainability and Dissemination
The project will involve collaboration and integration with primary health care renewal efforts and community resources to build on existing infrastructure and thereby help to facilitate sustainability. Capacity building within primary care settings and mobilization of existing resources will also help to ensure a sustainable resource. Steering Committee members and other partners will ensure the project results and products are shared with their organizations and networks, and also more widely across the province. Project findings will be published in appropriate peer reviewed publications to further share the learning and disseminate findings.
- Being tested
- Minimal Intervention, Motivational Interviewing, Motivational Enhancement
- Keywords
- preintervention and postintervention cohort longitudinal prospective study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal InterventionBehavioural
There is no clear definition of this term and it has been used by many different groups to refer to attempts to alter behavior by providing very brief, focused interventions. A slightly more developed model guiding intervention is called the 5-A model. This refers to the acronym Ask, Advise, Assess, Assist and Arrange. This model has been endorsed by the US Public Health Department, who has incorporated the 5-A approach into their clinical practice guidelines (A Clinical Practice Guideline for Treating Tobacco Use and Dependence; A US Public Health Service Report. JAMA, June 20, 2000 - Vol 283 No. 24; see also http://www.surgeongeneral.gov/tobacco/tobaqrg.htm).
Motivational InterviewingBehavioural
Motivational Interviewing has its roots in alcohol abuse counseling and was pioneered by Miller and Rollnick. It is an approach to counseling that is geared toward increasing an individual's motivation, or buy-in, to the work that needs to be done to reduce substance dependence. Miller and Rollnick offer the approach as a brief intervention (hence some confusion with the term minimal intervention) guided by the following mediators of change, which they call ingredients of change, summarized by the Acronym FRAMES:
FEEDBACK of personal risk or impairment Emphasis on personal RESPONSIBILITY for change Clear ADVICE to change A MENU of alternative change options Therapist EMPATHY Facilitation of client SELF-EFFICACY or optimism
These mediators/ingredients are delivered by the clinician using the following principles:
Express Empathy Develop Discrepancy Avoid Argumentation Roll with Resistance Support Self-Efficacy
Motivational EnhancementBehavioural
Motivational enhancement is the most comprehensive term and reflects the integration of two major theorists; Millner and Rollnick on the one hand, and Prochaska and his colleagues on the other. The work of Miller and Rollnick occurred within substance abuse, primarily alcohol abuse and is best summarized in the section above on motivational interviewing. As Prochaska's work, which initially began in the area of smoking cessation but quickly expanded to include wide-ranging health behaviours, developed Miller and Rollnick incorporated his work with theirs.Prochaska's model derives from his long term study of the process of behaviour change regardless of the model of intervention implemented.The model is often referred to as the stages of change model, or readiness to change model.
The stages of change model identifies five separate stages; precontemplation,contemplation, preparation, action, and maintenance
These stages are specific to different behaviours.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Duffus Street Medical Centre Receives: Behavioral: Minimal Intervention; Behavioral: Motivational Interviewing; Behavioral: Motivational Enhancement |
| 2 | Active comparator | Sydney Family Practice Receives: Behavioral: Minimal Intervention; Behavioral: Motivational Interviewing; Behavioral: Motivational Enhancement |
| no counseling | No intervention | HRA assessment pre and post but no counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
achievement of targeted mean reductions in overal global risk within patient risk strata Proportion of patients achieving their targeted mean reduction in global risk within risk strata
Measured: 12 months
Secondary outcomes (2)
determine the economic impact of a global risk assessment management process within a primary care setting
Measured: 12 months
percentage of patients that reduced at least one risk category from baseline
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startMar 2006
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk Reduction of Having a Coronary EventStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Masking
- None (open label)
- Enrolment
- 1,708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Cape Breton District Health Authority, Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620996
- Sponsor's protocol ID
- CD-2005-267
- Acronym
- ANCHOR
- Status last verified
- Jun 2008
- First submitted
- 13 Jun 2012
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cox JL, Vallis TM, Pfammatter A, Szpilfogel C, Carr B, O'Neill BJ. A novel approach to cardiovascular health by optimizing risk management (ANCHOR): behavioural modification in primary care effectively reduces global risk. Can J Cardiol. 2013 Nov;29(11):1400-7. doi: 10.1016/j.cjca.2013.03.007. Epub 2013 Jun 21.
PubMed 23796526
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Approach to Cardiovascular Health by Optimizing Risk Management (ANCHOR): A Primary Prevention Initiative Examining The Impact Of Global Risk Factor Assessment & Management On Health Care In Nova Scotia
- ClinicalTrials.gov ID
- NCT01620996
- Acronym / sponsor ID
- ANCHOR / CD-2005-267
- Keywords
- preintervention and postintervention cohort longitudinal prospective study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,708 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Cape Breton District Health Authority, Pfizer
- Study start
- Mar 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Jun 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.
Study Purpose and Design
The goal of this study is to improve CVD risk in a primary care adult population, with the following primary objectives
- To improve management of global cardiovascular risk of patients within two primary care practices, thereby improving their overall cardiac health.
- To increase patient compliance with lifestyle aimed at pharmaceutical interventions aimed at decreasing global cardiovascular risk.
Secondary objectives of the study are:
- To examine the utility of a process to improve the management of global cardiovascular risk of patients within two primary care practices.
- To explore the utility of a process that links primary care practices with existing community resources in order to manage cardiac risk factors better among individuals within those primary care practices.
- To determine the economic impact of a global risk assessment and management process within a primary care setting.
Detailed description
The Burden of Cardiovascular Disease
Cardiovascular disease (CVD) remains the major cause of mortality in the developed world, accounting for almost 40% of all deaths in both the United States and Canada. It represents a substantial financial drain on society and contributes a significant burden to health care systems that are already under strain. Major modifiable risk factors for CVD include elevated blood pressure, cigarette smoking, elevated total plasma cholesterol and low high-density lipoproteins, diabetes, obesity, and sedentary lifestyle, at least one of which is present in 80% of Canadians. Circulatory diseases (particularly heart disease, stroke and hypertension) cost the Nova Scotia health care system an estimated $961 million dollars per year. In Nova Scotia cardiovascular disease kills an estimated 2,900 Nova Scotians every year accounting for nearly 36% of all deaths in the province.
Cardiovascular Disease Prevention in Primary Care Settings
There is strong evidence linking improved risk factors among populations to improved health outcomes, and both epidemiological and community research have illustrated that the bulk of non-communicable diseases (NCDs) such as CVD are preventable, or at least their occurrence can be postponed. Because primary care physicians are most often the first point of contact for individuals in need of health care, general practice is well placed to facilitate change in patients' risk factor status and ensure more effective treatment of risk factors such as hypertension and hyperlipidemia. Currently primary care service delivery is expanding to include a broader network of providers such as nurses, dieticians, and pharmacists to enable more effective risk factor identification and management, and health promotion and disease prevention efforts across the continuum of care.
Nova Scotia Context
Currently in Nova Scotia, population health and disease prevention initiatives are underway that will support and reinforce the work of the current study, including primary health care transition fund initiatives, and strategic directions from the Office of Health Promotion that address major risk factors for cardiovascular disease. These provincial initiatives together with local projects ongoing in several communities provide an ideal opportunity for interfacing with a primary care global risk reduction initiative.
Study Purpose and Design
The goal of this study is to improve CVD risk in a primary care adult population, with the following primary objectives
- To improve management of global cardiovascular risk of patients within two primary care practices, thereby improving their overall cardiac health.
- To increase patient compliance with lifestyle and pharmaceutical interventions aimed at decreasing global cardiovascular risk.
Secondary objectives of the study are:
- To examine the utility of a process to improve the management of global cardiovascular risk of patients within two primary care practices.
- To explore the utility of a process that links primary care practices with existing community resources in order to manage cardiac risk factors better among individuals within those primary care practices.
- To determine the economic impact of a global risk assessment and management process within a primary care setting.
The intervention will be led by a study coordinator in each primary care setting and consist of a recruitment strategy, global risk factor assessment, behaviour change counseling, and risk factor management strategies based on the 5A's framework (assess, advise, agree, assist and arrange follow-up). Supports will be provided to study participants in making behaviour changes including counseling and follow-up, behaviour change tools, print resources, group education sessions, and an inventory of and links to community programs. Medication reviews and physician referrals will also be completed as required.
A Steering Committee will guide the project and includes membership from the Principal Investigators, representatives from Pfizer Canada, Capital District Health Authority, the Cape Breton District Health Authority and the Nova Scotia Department of Health; and community stakeholders including community pharmacy, a physician and/or nurse from each site, other relevant allied health professionals (e.g., nutritionist) and the CEO from the Heart and Stroke Foundation of Nova Scotia. The initiative will be conducted over a three-year period and will comprise three phases as outlined in the following table.
Research Methodology
This is a pre-intervention and post-intervention longitudinal, prospective pilot study to evaluate study participants achievement of CVD risk factor reduction. The research will include a combination of quantitative and qualitative data to judge effectiveness of the interventions and to describe the intervention as it is implemented. The effectiveness of the approach will be examined using pre and post measures of key outcome variables. In addition to these outcome measures, process evaluation will monitor and assess the implementation of the interventions. The study will include baselines measurement, periodic assessments of process measures, outcome measurement and follow-up measurement. Following the baseline measurement through the GRA, patients will receive risk management interventions.
The data will be analyzed using both quantitative and qualitative methods. Pre and post outcome measures will be analyzed using descriptive analytical techniques comparing means for continuous measures and proportions for categorical measures. Qualitative data will be managed and analyzed either manually or via QSR NUD*IST (Qualitative Solutions and Research Non-numerical Unstructured Data Indexing Searching and Theory-building) software. The qualitative analysis will consist of both content and thematic analysis.
Sustainability and Dissemination
The project will involve collaboration and integration with primary health care renewal efforts and community resources to build on existing infrastructure and thereby help to facilitate sustainability. Capacity building within primary care settings and mobilization of existing resources will also help to ensure a sustainable resource. Steering Committee members and other partners will ensure the project results and products are shared with their organizations and networks, and also more widely across the province. Project findings will be published in appropriate peer reviewed publications to further share the learning and disseminate findings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Minimal Intervention, Behavioral: Motivational Interviewing, Behavioral: Motivational EnhancementDuffus Street Medical Centre |
| 2 | Active comparator | Behavioral: Minimal Intervention, Behavioral: Motivational Interviewing, Behavioral: Motivational EnhancementSydney Family Practice |
| no counseling | No intervention | –HRA assessment pre and post but no counselling |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 30 years of age
- a patient of the primary care practices involved in the study
- able to provide informed consent
Key exclusion criteria (3 listed)
- under the age of 30
- not a patient of the primary care practices
- unable to provide informed consent
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 |
|---|---|---|
| Minimal InterventionThere is no clear definition of this term and it has been used by many different groups to refer to attempts to alter behavior by providing very brief, focused interventions. A slightly more developed model guiding intervention is called the 5-A model. This refers to the acronym Ask, Advise, Assess, Assist and Arrange. This model has been endorsed by the US Public Health Department, who has incorporated the 5-A approach into their clinical practice guidelines (A Clinical Practice Guideline for Treating Tobacco Use and Dependence; A US Public Health Service Report. JAMA, June 20, 2000 - Vol 283 No. 24; see also http://www.surgeongeneral.gov/tobacco/tobaqrg.htm). | Behavioural | 1, 2 |
| Motivational InterviewingMotivational Interviewing has its roots in alcohol abuse counseling and was pioneered by Miller and Rollnick. It is an approach to counseling that is geared toward increasing an individual's motivation, or buy-in, to the work that needs to be done to reduce substance dependence. Miller and Rollnick offer the approach as a brief intervention (hence some confusion with the term minimal intervention) guided by the following mediators of change, which they call ingredients of change, summarized by the Acronym FRAMES: FEEDBACK of personal risk or impairment Emphasis on personal RESPONSIBILITY for change Clear ADVICE to change A MENU of alternative change options Therapist EMPATHY Facilitation of client SELF-EFFICACY or optimism These mediators/ingredients are delivered by the clinician using the following principles: Express Empathy Develop Discrepancy Avoid Argumentation Roll with Resistance Support Self-Efficacy | Behavioural | 1, 2 |
| Motivational EnhancementMotivational enhancement is the most comprehensive term and reflects the integration of two major theorists; Millner and Rollnick on the one hand, and Prochaska and his colleagues on the other. The work of Miller and Rollnick occurred within substance abuse, primarily alcohol abuse and is best summarized in the section above on motivational interviewing. As Prochaska's work, which initially began in the area of smoking cessation but quickly expanded to include wide-ranging health behaviours, developed Miller and Rollnick incorporated his work with theirs.Prochaska's model derives from his long term study of the process of behaviour change regardless of the model of intervention implemented.The model is often referred to as the stages of change model, or readiness to change model. The stages of change model identifies five separate stages; precontemplation,contemplation, preparation, action, and maintenance These stages are specific to different behaviours. | Behavioural | 1, 2 |
Primary outcome
achievement of targeted mean reductions in overal global risk within patient risk strata Proportion of patients achieving their targeted mean reduction in global risk within risk strata
Time frame: 12 months
2 secondary outcomes
determine the economic impact of a global risk assessment management process within a primary care setting
Time frame: 12 months
percentage of patients that reduced at least one risk category from baseline
Time frame: 12 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 15 Nov 2022.
- Derived from this study: PubMed 23796526Cox JL, Vallis TM, Pfammatter A, Szpilfogel C, Carr B, O'Neill BJ. A novel approach to cardiovascular health by optimizing risk management (ANCHOR): behavioural modification in primary care effectively reduces global risk. Can J Cardiol. 2013 Nov;29(11):1400-7. doi: 10.1016/j.cjca.2013.03.007. Epub 2013 Jun 21.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal Intervention, Motivational Interviewing and Motivational Enhancement in people with Cardiovascular Risk Reduction of Having a Coronary Event, run by Nova Scotia Health Authority 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 3 inclusion and 3 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 15 Nov 2022. 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?
achievement of targeted mean reductions in overal global risk within patient risk strata Proportion of patients achieving their targeted mean reduction in global risk within risk strata (time frame: 12 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 NCT01620996, which also lists 1 linked publication.
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 15 Nov 2022.