SMART to Optimize an Intervention to Maintain Health Improvements After Cardiac Rehabilitation (EMPOWER ME)

April 27, 2026 updated by: The Miriam Hospital

An Application of SMART Methodology to Optimize an Intervention to Maintain Improvements in Health Behaviors in Under-resourced Patients After Phase II Cardiac Rehabilitation

The study is sponsored by the National Heart, Lung, and Blood Institute, which is part of the National Institutes of Health. The study expects to enroll 400 subjects. The research team will recruit research participants that are finishing or will finish cardiac rehabilitation soon. Participants belong to one or more groups of people who are less often studied in cardiac rehabilitation research, may have less access to a formal cardiac rehabilitation maintenance program, or they may especially benefit from additional support after cardiac rehabilitation ends. The main purposes of this study are to evaluate which treatments work the best after cardiac rehabilitation, which order to deliver the treatments in, and which treatments are as minimally burdensome as possible while still working well. This study will make two comparisons (one comparison between a set of low-intensity interventions and another between a set of higher-intensity interventions) to determine which produces the best behavioral adherence immediately after Phase II (outpatient) cardiac rehabilitation

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The research team will first test which of two automated online interventions ([A] a low-intensity text-messaging intervention of 3 weekly sets of text messages focused on encouragement and reminders about the key health behaviors for 2 months, or [B] a fully automated 2-month online program modeled on our previous research, consisting of interactive lessons, self-monitoring, and tailored feedback) serves as the best first-line intervention. The second test is which of two home-based cardiac rehabilitation (CR) maintenance interventions produces the best outcomes for non-responders to the initial interventions. Those who do not respond to the low-intensity interventions will be randomized to receive 3 months of either (C) low-intensity home-based CR, consisting of education and exercise prescription, or (D) high-intensity home-based online CR that includes education and exercise prescription plus case management. Adherence to the 3 targeted cardioprotective behaviors will be measured after Phase II completion (baseline), the initial low-touch interventions (at Month 3), after 3 more months of continued or new interventions (at Month 6), and 6-months of no-treatment follow-up (at Month 12). The primary outcome will be adherence to the 3 cardioprotective behaviors (physical activity, weight management, and medication adherence) measured together in the Sequential, Multiple Assignment, Randomized Trials (SMART) decision rule (responder status) and individually. Exploratory outcomes will be death, rehospitalization, and quality of life. The specific aims of this study are to: (1) Compare the 2 least intensive, online, intervention options (text message versus an automated online program) to determine which produces the best behavioral adherence immediately after Phase II CR; (2) Determine whether low- or high-intensity home-based CR (i.e., with or without case management) produces superior behavioral adherence after failure of initial low-intensity online intervention; (3) Finalize the adaptive treatment based on the results of the first two aims; and (4) [Exploratory Aim] Conduct a moderators analysis to test for differential effects within specific participant groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Weight Control and Diabetes Research Center of The Miriam Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carly M Goldstein, PhD, FAACVPR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years of age or older
  • Have completed at least 6 CR sessions
  • Must enroll within 6 weeks of their final CR session
  • BMI ≥27
  • Own an internet-connected device
  • Home internet access
  • English proficiency
  • Able to walk ≥1 block without stopping

Lastly, the participant MUST belong to ≥1 of the following groups or identities:

  • Identifies as a woman
  • Identifies as LGBTQIA+
  • Identifies as a racial or ethnic minority
  • Insecure transportation for medical appointments
  • Self-reported trouble paying for healthcare needs (e.g., copays)
  • Receive income-based subsidized benefits (e.g., state-funded health insurance for low-income residents)
  • Reside in a small town or rural area per 2010 United States Department of Agriculture Rural-Urban Commuting Area zip code or the Distressed Communities Index
  • Low educational attainment (≤high school diploma)
  • Low household income (less than twice the Federal Poverty Level) or meeting federal poverty guidelines per the National Committee on Vital and Health Statistics and the Department of Health and Human Services)

Exclusion Criteria:

  • New York Heart Association Class IV heart failure
  • Heart transplant in the last 5 months
  • Left ventricular assist device in the last 4 months
  • Physician diagnosis of dementia
  • Physician prescription for 24 hours of oxygen therapy daily
  • Coronary artery bypass surgery in the last 3 months
  • Current dialysis
  • Chronic gait or balance disturbances that would make unsupervised exercise unsafe
  • Current pregnancy
  • Report of conditions that the investigators believe would render them potentially unlikely to follow the protocol including terminal illness, active substance dependence, or other significant psychiatric problems that require inpatient hospitalization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: First Intervention: Text Messaging, Second Intervention: Continued Text Messaging
Participants are first randomized to the low-intensity text messaging intervention. On 3 days/week they receive a text about 1 of the 3 behaviors (weight maintenance or loss, physical activity, and medication adherence) in randomized order with guidance for maintaining or improving these behaviors to reach program-provided goals. The system compares their last week's adherence to the responder criteria. They receive feedback praising adherence and instructions for a theory-driven behavioral strategy (e.g., stimulus control) to increase adherence. Feedback is tailored to the patient's adherence or existence of self-monitoring data. Participants meeting responder criteria after 2 months will continue to receive the text messaging intervention for the next 3 months.
Behavioral: Text Messaging
On 3 days/week they receive a text about 1 of the 3 behaviors (weight maintenance or loss, physical activity, and medication adherence) in randomized order with guidance for maintaining or improving these behaviors to reach program-provided goals. The system compares their last week's adherence to the responder criteria. They receive feedback praising adherence and instructions for a theory-driven behavioral strategy (e.g., stimulus control) to increase adherence. Feedback is tailored to the patient's adherence or existence of self-monitoring data.
Experimental: First Intervention: Text Messaging, Second Intervention: Low-Intensity Cardiac Rehabilitation
Participants receive the text messaging intervention for 2 months. Following their mid-intervention assessment, they are randomized to receive the low-intensity cardiac rehabilitation maintenance program. Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.
Behavioral: Text Messaging
On 3 days/week they receive a text about 1 of the 3 behaviors (weight maintenance or loss, physical activity, and medication adherence) in randomized order with guidance for maintaining or improving these behaviors to reach program-provided goals. The system compares their last week's adherence to the responder criteria. They receive feedback praising adherence and instructions for a theory-driven behavioral strategy (e.g., stimulus control) to increase adherence. Feedback is tailored to the patient's adherence or existence of self-monitoring data.
Behavioral: Low-Intensity Cardiac Rehabilitation Maintenance Program
Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.
Experimental: First Intervention: Text Messaging, Second Intervention: High-Intensity Cardiac Rehabilitation
Participants receive the text messaging intervention for 2 months. Following their mid-intervention assessment, they are randomized to receive the high-intensity cardiac rehabilitation maintenance program. Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily and attend a once weekly virtual meeting with a CR case manager. Meetings are modeled after Phase II and focus on tailored exercise prescription, addressing cognitive, behavioral, and environmental adherence barriers, and support. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.
Behavioral: Text Messaging
On 3 days/week they receive a text about 1 of the 3 behaviors (weight maintenance or loss, physical activity, and medication adherence) in randomized order with guidance for maintaining or improving these behaviors to reach program-provided goals. The system compares their last week's adherence to the responder criteria. They receive feedback praising adherence and instructions for a theory-driven behavioral strategy (e.g., stimulus control) to increase adherence. Feedback is tailored to the patient's adherence or existence of self-monitoring data.
Behavioral: High Intensity Cardiac Rehabilitation Maintenance Program
Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily and attend a once weekly virtual meeting with a CR case manager. Meetings are modeled after Phase II and focus on tailored exercise prescription, addressing cognitive, behavioral, and environmental adherence barriers, and support. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.
Experimental: First Intervention: Fully Automated Online Program (FAOP), Second Intervention: Continued FAOP
Patients receiving the fully automated online program will select a weight loss or a weight maintenance curriculum based on their goals. Patients will receive 8 weeks of fully automated lessons covering the 3 key behaviors: weight (management or loss), physical activity, and medication adherence. All 3 behaviors are discussed weekly, but the lessons first prioritize PA, then weight management, and then medication adherence to mimic the emphasis in Phase II. Total weekly lesson time is 20-30 minutes. Patients retain access to lessons. They self-monitor calories, weight, moderate-to-vigorous physical activity, and medication adherence. Tracking data are seamlessly integrated into the system. They manually enter their medication adherence data and receive encouraging feedback on each of the behaviors the next week. Participants meeting responder criteria after 2 months will continue to receive the fully automated online program.
Behavioral: Fully Automated Online Program
Patients receiving the fully automated online program will select a weight loss or a weight maintenance curriculum based on their goals. Patients will receive 8 weeks of fully automated lessons covering the 3 key behaviors: weight (management or loss), physical activity, and medication adherence. All 3 behaviors are discussed weekly, but the lessons first prioritize PA, then weight management, and then medication adherence to mimic the emphasis in Phase II. Total weekly lesson time is 20-30 minutes. Patients retain access to lessons. They self-monitor calories, weight, moderate-to-vigorous physical activity, and medication adherence. Tracking data are seamlessly integrated into the system. They manually enter their medication adherence data and receive encouraging feedback on each of the behaviors the next week.
Experimental: First Intervention: FAOP, Second Intervention: Low-Intensity Cardiac Rehabilitation
Participants receive the fully automated online program for 2 months. Following their mid-intervention assessment, they are randomized to receive the low-intensity cardiac rehabilitation maintenance program. Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.
Behavioral: Low-Intensity Cardiac Rehabilitation Maintenance Program
Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.
Behavioral: Fully Automated Online Program
Patients receiving the fully automated online program will select a weight loss or a weight maintenance curriculum based on their goals. Patients will receive 8 weeks of fully automated lessons covering the 3 key behaviors: weight (management or loss), physical activity, and medication adherence. All 3 behaviors are discussed weekly, but the lessons first prioritize PA, then weight management, and then medication adherence to mimic the emphasis in Phase II. Total weekly lesson time is 20-30 minutes. Patients retain access to lessons. They self-monitor calories, weight, moderate-to-vigorous physical activity, and medication adherence. Tracking data are seamlessly integrated into the system. They manually enter their medication adherence data and receive encouraging feedback on each of the behaviors the next week.
Experimental: First Intervention: FAOP, Second Intervention: High-Intensity Cardiac Rehabilitation
Participants receive the fully automated online program intervention for 2 months. Following their mid-intervention assessment, they are randomized to receive the high-intensity cardiac rehabilitation maintenance program. Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily and attend a once weekly virtual meeting with a CR case manager. Meetings are modeled after Phase II and focus on tailored exercise prescription, addressing cognitive, behavioral, and environmental adherence barriers, and support. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in (after they miss a login) if they log in less than twice weekly.
Behavioral: High Intensity Cardiac Rehabilitation Maintenance Program
Patients are instructed to log in 3 times weekly to view lessons, sync their Fitbit data, and complete a home-based workout video. They track weight, PA, and medication adherence daily and attend a once weekly virtual meeting with a CR case manager. Meetings are modeled after Phase II and focus on tailored exercise prescription, addressing cognitive, behavioral, and environmental adherence barriers, and support. Patients have access to an extensive CR resource library made and curated by the platform provider plus resources on maintaining heart healthy behaviors during Phase III created by the research team. They are reminded to log in if they log in less than twice weekly.
Behavioral: Fully Automated Online Program
Patients receiving the fully automated online program will select a weight loss or a weight maintenance curriculum based on their goals. Patients will receive 8 weeks of fully automated lessons covering the 3 key behaviors: weight (management or loss), physical activity, and medication adherence. All 3 behaviors are discussed weekly, but the lessons first prioritize PA, then weight management, and then medication adherence to mimic the emphasis in Phase II. Total weekly lesson time is 20-30 minutes. Patients retain access to lessons. They self-monitor calories, weight, moderate-to-vigorous physical activity, and medication adherence. Tracking data are seamlessly integrated into the system. They manually enter their medication adherence data and receive encouraging feedback on each of the behaviors the next week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weight Management
Time Frame: From enrollment to the post-intervention assessment at 6 months
Weight will be measured to the nearest 0.1 kg with a digital scale in light indoor clothing without shoes. Height will be measured to the nearest millimeter with standard stadiometer procedures; those without a recent (≤3 months) clinic height measurement will be sent a paper tape measure to be taped to a wall. BMI will be calculated (kg/m2). Local participants may come to the research center. Patients will be shipped a cellular-enabled scale to be used in the same location in their home for all assessments and will keep scales between assessments. Percent weight loss or management will be calculated as current weight/baseline weight.
From enrollment to the post-intervention assessment at 6 months
Physical Activity
Time Frame: From enrollment to the post-intervention assessment at 6 months
PA will be objectively measured over the 7-day assessment period via wearing the Fitbit on their wrist during waking hours. The Clinical Research Technologist can monitor device wear time during assessments and prompt participants to wear the device during their assessment period. Valid wear days will be defined as ≥600 min wear time during awake hours (e.g., 7am to 11pm; hours chosen with participant input) measured by non-zero heart rate measurements during that time and include patients with ≥4 valid days, including 1 weekend day. Fitbit allows researchers access to raw sensor data in 60 sec epochs via their API. Estimated mins/day spent in total PA and specific intensities of activities will be based on vertical axis counts/min thresholds primarily reflecting locomotor activity. The primary PA variable of interest will be MVPA mins/week.
From enrollment to the post-intervention assessment at 6 months
Medication Adherence
Time Frame: From enrollment to the post-intervention assessment at 6 months
Participants will complete a pill count of their total supply of common CVD medications. The medications will be counted at the assessment week beginning and end. Patients will complete the count twice; if the 2 do not agree, they will complete a third. The total number of pills will be recorded at each pill count. Percent adherence for each medication will be calculated as the difference between the baseline and end-of-treatment counts for that medication divided by the number of prescribed pills for that medication; this value will be multiplied by 100. Percent adherence per medication will be the difference between the baseline and end-of-treatment counts for that medication divided by the number of prescribed pills for that medication multiplied by 100. Percent adherence across medications will be the difference between baseline and end-of-treatment counts across all medications divided by the total number of prescribed pills for the 7-day period multiplied by 100.
From enrollment to the post-intervention assessment at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hospitalizations
Time Frame: 12 months after enrollment
Number of hospitalizations
12 months after enrollment
Death
Time Frame: 12 months after enrollment
Patients, the designated contacts, or the medical chart will provide information in the event that the participant has passed away since enrollment
12 months after enrollment
Quality of life via the 36-Item Short-Form Survey
Time Frame: 12 months after enrollment
Participants who are reached for the final assessment will complete a short survey form online or on the phone to measure their quality of life. This survey has 36 questions. Each question has 2-5 possible answer options. Responses are recoded to be on a 0-100 scale, and higher values indicate better perceived health.
12 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Miriam Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
Office of the Director, National Institutes of Health (OD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1R01HL171158-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the risk of re-identification in some communities, IPD will not be shared in this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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