Coronary Artery Bypass GraftNCT03299101
Pilot Testing a Home-Based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
A study testing Prehabilitation in people with Coronary Artery Bypass Graft and Non-cardiac Thoracic Surgery, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran population grows older and more frail, there is a critical need to identify effective strategies for reducing surgical risks for these patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Bypass Graft, Non-cardiac Thoracic Surgery, Frailty
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2017to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Veteran patient scheduled for Coronary artery bypass graft (CABG), valve surgery, or other non-cardiac thoracic surgery;
- Demonstrate at least mild frailty (e.g., Risk Analysis Index [RAI]>=16).
- Physician/provider request for patients with RAI<16.
Who cannot join
- Emergent, urgent, or otherwise time-sensitive surgery that precludes prehabilitation;
- Unstable or recent unstable cardiac syndrome as defined by (a) acute coronary syndrome within 6 weeks; (b) decompensated heart failure; (c) New York Heart Association Class IV Heart Failure; (d) unstable angina; (e) Canadian Cardiovascular Society Class IV symptoms; (f) critical left main coronary disease; (g) clinically significant arrhythmias,
- Severe valvular heart disease: (a) severe aortic or mitral stenosis (aortic or mitral valve area <1.0 cm2 or mean gradient >40 or >10 mm Hg, respectively)
- Dynamic LV (Left Ventricle) outflow obstruction
- Physical, cognitive, social or logistical limitations preventing participation in the prehabilitation regimen, including:
- Patients who require surrogate consent for the planned surgery
Show all 11Show fewer
- Patients with court orders of incompetence or clinical determinations of incapacity documented in the medical record
- Clinical exam by study physician consistent with incapacity
- Patients who at any time during prehabilitation or longitudinal follow up demonstrate insufficient cognitive capacity to safely and effectively carry out the prescribed activities.
- Unable to speak English.
- Surgery is cancelled by IMPACT clinic or surgeon due to unacceptable risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240
About this study
Official title: Pilot Testing a Home-based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran population grows older and more frail, there is a critical need to identify effective strategies for reducing surgical risks for these patients. Prior research shows that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. The investigators believe that similar improvements may be obtained by using similar interventions before surgery to "prehabilitate" patients' capacity to tolerate the stress of surgery. The proposed research will examine the feasibility of a new, home-based prehabilitation intervention aimed at improving surgical outcomes after cardiothoracic surgery through preoperative exercise training and nutritional supplementation. Findings from the study will inform the design of a larger randomized controlled trial of the prehabilitation intervention. If proven effective, prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major elective surgery each year.
Read the detailed description
Background: Frail Veterans are at increased risk for poor surgical outcomes. Although surgical techniques have advanced to a level where surgery on very old adults is feasible, if a patient is also frail, the stress of surgery may overwhelm their adaptive capacities, placing them at increased risk of mortality, morbidity, and institutionalization even if surgery is technically successful. Frailty is a clinical syndrome that is commonly characterized by muscle atrophy, diminished strength and speed, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age and worsens disease prognoses by diminishing capacity to tolerate stressors. Thus, while surgery is often indicated for older patients, frail candidates are less likely than robust counterparts to tolerate the procedure and/or recover functional capacity. In fact, recent VA data demonstrate that frailty is a more powerful predictor of increased perioperative mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity alone. As the Veteran and US populations grow older, frailty will increase, making it critically important to identify effective strategies for improving the surgical recovery and outcomes of frail patients.
"Prehabilitation" has the potential to improve surgical outcomes among the frail. Prior research demonstrates that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. Based on this success, there is growing interest in "prehabilitation", which is a similar intervention deployed before surgery. By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of surgery itself and the convalescent period thereafter. Frail patients may benefit disproportionately from prehabilitation because they have diminished capacity to endure the procedure and/or recovery. Preliminary evidence suggests that preoperative exercise interventions improve surgical outcomes. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations, and no prior studies used home-based prehabilitation strategies to safely minimize travel-related barriers to participation.
Objectives: The investigators will examine the feasibility of a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Specific aims are to:
- Estimate rates of recruitment, retention, and adherence to the intervention; and evaluate participation barriers.
- Measure changes over time in frailty, physical function, pulmonary function, nutrition, and health-related quality of life at baseline, the day of surgery, and 30 and 90 days after surgery.
- Explore changes in postoperative mortality, major complications, length of hospital stay, and level of independent living using case-matched historical controls.
Methods: This single-arm pilot study will enroll a consecutive cohort of up to 50 Veterans identified as frail using a standardized frailty assessment and scheduled for major cardiothoracic surgery at the VA Pittsburgh Healthcare System. The 4 week long prehabilitation regimen will include: (a) aerobic conditioning, (b) strength and coordination training, (c) respiratory muscle training, and (d) nutritional coaching and supplementation. Pre- and post-prehabilitation assessments will include: (a) frailty; (b) physical function; (c) pulmonary function; (d) nutrition; and (e) health-related quality of life. Postoperative outcomes will include length of stay, mortality and complications. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will inform a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the 42,000 frail Veterans scheduled for major elective surgery each year.
- Being tested
- Prehabilitation
- Keywords
- Frailty, Prehabilitation, Exercise therapy, Surgery, Nutrition support
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Prospective sample of patients anticipating cardiothoracic surgery. Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
Measured: Baseline
Retention Rate
Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.
Measured: 90 days postoperatively
Adherence Rate
Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.
Measured: Day of surgery
Secondary outcomes (14)
Change in Grip Strength Over the Course of Treatment and Recovery.
Grip strength will be measured in kilograms of pressure using a Smedley grip dynamometer
Measured: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP
Pulmonary function will be measured in terms of maximum MIP (maximal inspiratory pressure).
Measured: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP
Pulmonary function will be measured in terms of mean maximal inspiratory pressure (MIP).
Measured: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP
Pulmonary function will be measured in terms of maximum MEP (maximal expiratory pressures)
Measured: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP
Pulmonary function will be measured in terms of mean maximal expiratory pressures (MEP).
Measured: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP
Pulmonary function will be measured in terms of maximum sustained MIP (SMIP).
Measured: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP
Pulmonary function will be measured in terms of mean sustained MIP (SMIP).
Measured: Baseline, day of surgery, 90 days postoperatively
Serum Prealbumin Over the Course of Treatment and Recovery
Higher levels indicate greater levels of protein. Lower levels indicate the potential of inflammation. normal range is 18-41, Below 18 is lower than normal, above 41 is higher than normal
Measured: Baseline, day of surgery, 90 days postoperatively
Change in Gait Speed Over the Course of Treatment and Recovery
Gait speed will be measured by using a stopwatch to time how long the patient takes to walk 4 meters
Measured: Baseline, day of surgery, 90 days postoperatively
Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery
This standardized outcome measure asks patients to complete several activities that are scored independently and then aggregated into an overall score ranging from 0-12. Higher scores indicate better physical performance.
Measured: Baseline, day of surgery, 90 days postoperatively
Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
This recently published frailty index is assessed by a clinician administered questionnaire. The score and reflects frailty-associated mortality risk ranging from 0-81. Higher scores indicate higher risk for post operative complications and other frailty-related outcomes.
Measured: Baseline, day of surgery, 90 days postoperatively
Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery
This standardized survey instrument is completed by a trained clinician after assessing a nutrition-specific patient history. The minimum score is 1 and the maximum score is 7. High scores indicate better nourishment.
Measured: Baseline, day of surgery, 90 days postoperatively
Change in 6 Minute Walk Test Over the Course of Treatment and Recovery
This standardized approach measures the distance in meters walked during 6 minutes.
Measured: Baseline, day of surgery, 90 days postoperatively
Change in Health Related Quality of Life Over the Course of Treatment and Recovery
Assessment of Quality of Life (AQoL-6D) survey. Scores range from 0 to 1. The higher the score, the better the quality of life.
Measured: Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start22 Nov 2017
- Primary completion30 Apr 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- A novel a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Prehabilitation will include: (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Daniel E. Hall, MD MDiv MHSc, Principal investigator, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299101
- Sponsor's protocol ID
- E2562-P
- Other IDs
- I21RX002562
- Status last verified
- Dec 2020
- First submitted
- 18 Sep 2017
- Last updated
- 13 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Home-based Rehabilitation Intervention Designed to Improve Outcomes of Frail Veterans Following Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT03299101
- Acronym / sponsor ID
- E2562-P
- Keywords
- Frailty, Prehabilitation, Exercise therapy, Surgery, Nutrition support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 2 Oct 2017 (actual)
- Results
- Posted 21 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Frail Veterans are at increased risk for poor surgical outcomes, and as the Veteran population grows older and more frail, there is a critical need to identify effective strategies for reducing surgical risks for these patients. Prior research shows that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. The investigators believe that similar improvements may be obtained by using similar interventions before surgery to "prehabilitate" patients' capacity to tolerate the stress of surgery. The proposed research will examine the feasibility of a new, home-based prehabilitation intervention aimed at improving surgical outcomes after cardiothoracic surgery through preoperative exercise training and nutritional supplementation. Findings from the study will inform the design of a larger randomized controlled trial of the prehabilitation intervention. If proven effective, prehabilitation could benefit as many as 42,000 frail Veterans who are scheduled for major elective surgery each year.
Detailed description
Background: Frail Veterans are at increased risk for poor surgical outcomes. Although surgical techniques have advanced to a level where surgery on very old adults is feasible, if a patient is also frail, the stress of surgery may overwhelm their adaptive capacities, placing them at increased risk of mortality, morbidity, and institutionalization even if surgery is technically successful. Frailty is a clinical syndrome that is commonly characterized by muscle atrophy, diminished strength and speed, decreased physical activity, and exhaustion. It is independent of any specific disease, but it increases with age and worsens disease prognoses by diminishing capacity to tolerate stressors. Thus, while surgery is often indicated for older patients, frail candidates are less likely than robust counterparts to tolerate the procedure and/or recover functional capacity. In fact, recent VA data demonstrate that frailty is a more powerful predictor of increased perioperative mortality, morbidity, length of stay, and cost than predictions based on age or comorbidity alone. As the Veteran and US populations grow older, frailty will increase, making it critically important to identify effective strategies for improving the surgical recovery and outcomes of frail patients.
"Prehabilitation" has the potential to improve surgical outcomes among the frail. Prior research demonstrates that inter-disciplinary rehabilitation strategies deployed after surgery enhance recovery and improve outcomes by building strength and improving nutrition. Based on this success, there is growing interest in "prehabilitation", which is a similar intervention deployed before surgery. By modifying physiological and environmental risks, prehabilitation aims to augment patients' capacity to compensate for the stress of surgery itself and the convalescent period thereafter. Frail patients may benefit disproportionately from prehabilitation because they have diminished capacity to endure the procedure and/or recovery. Preliminary evidence suggests that preoperative exercise interventions improve surgical outcomes. However, prehabilitation has not yet been studied in either Veteran or specifically frail populations, and no prior studies used home-based prehabilitation strategies to safely minimize travel-related barriers to participation.
Objectives: The investigators will examine the feasibility of a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Specific aims are to:
- Estimate rates of recruitment, retention, and adherence to the intervention; and evaluate participation barriers.
- Measure changes over time in frailty, physical function, pulmonary function, nutrition, and health-related quality of life at baseline, the day of surgery, and 30 and 90 days after surgery.
- Explore changes in postoperative mortality, major complications, length of hospital stay, and level of independent living using case-matched historical controls.
Methods: This single-arm pilot study will enroll a consecutive cohort of up to 50 Veterans identified as frail using a standardized frailty assessment and scheduled for major cardiothoracic surgery at the VA Pittsburgh Healthcare System. The 4 week long prehabilitation regimen will include: (a) aerobic conditioning, (b) strength and coordination training, (c) respiratory muscle training, and (d) nutritional coaching and supplementation. Pre- and post-prehabilitation assessments will include: (a) frailty; (b) physical function; (c) pulmonary function; (d) nutrition; and (e) health-related quality of life. Postoperative outcomes will include length of stay, mortality and complications. Compliance with the prehabilitation regimen will be assessed through patient logs and pedometers. Analyses will inform a larger randomized controlled trial testing the prehabilitation intervention. Findings will be relevant for the 42,000 frail Veterans scheduled for major elective surgery each year.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A novel a novel, multifaceted, home-based prehabilitation intervention designed to improve functional capacity and postoperative outcomes for frail Veterans anticipating cardiothoracic surgery. Prehabilitation will include: (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: PrehabilitationProspective sample of patients anticipating cardiothoracic surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Veteran patient scheduled for Coronary artery bypass graft (CABG), valve surgery, or other non-cardiac thoracic surgery;
- Demonstrate at least mild frailty (e.g., Risk Analysis Index [RAI]>=16).
- Physician/provider request for patients with RAI<16.
Key exclusion criteria (11 listed)
- Emergent, urgent, or otherwise time-sensitive surgery that precludes prehabilitation;
- Unstable or recent unstable cardiac syndrome as defined by (a) acute coronary syndrome within 6 weeks; (b) decompensated heart failure; (c) New York Heart Association Class IV Heart Failure; (d) unstable angina; (e) Canadian Cardiovascular Society Class IV symptoms; (f) critical left main coronary disease; (g) clinically significant arrhythmias,
- Severe valvular heart disease: (a) severe aortic or mitral stenosis (aortic or mitral valve area <1.0 cm2 or mean gradient >40 or >10 mm Hg, respectively)
- Dynamic LV (Left Ventricle) outflow obstruction
- Physical, cognitive, social or logistical limitations preventing participation in the prehabilitation regimen, including:
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 |
|---|---|---|
| PrehabilitationPrehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation. | Other | Prehabilitation |
Primary outcome
Recruitment Rate
Time frame: Baseline
Recruitment will be expressed as the percentage of eligible patients approached who agree to participate in this pilot study.
Retention Rate
Time frame: 90 days postoperatively
Retention rate will be expressed as the percentage of enrolled patients who were retained in the study and completed study procedures. It will be calculated for incremental steps along the study timeline and at the completion of study procedures 90 days postoperatively.
Adherence Rate
Time frame: Day of surgery
Compliance rates will be expressed as the percentage of assigned activities actually completed by patients as recorded in home exercise and nutrition logs.
14 secondary outcomes
Change in Grip Strength Over the Course of Treatment and Recovery.
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MIP
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MIP
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max MEP
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean MEP
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Max SMIP
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in Pulmonary Function Over the Course of Treatment and Recovery: Mean SMIP
Time frame: Baseline, day of surgery, 90 days postoperatively
Serum Prealbumin Over the Course of Treatment and Recovery
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in Gait Speed Over the Course of Treatment and Recovery
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in Short Physical Performance Battery (SPPB) Over the Course of Treatment and Recovery
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in Risk Analysis Index of Frailty (RAI) Over the Course of Treatment and Recovery
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in 7-point Subjective Global Assessment (SGA) of Nutrition Over the Course of Treatment and Recovery
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in 6 Minute Walk Test Over the Course of Treatment and Recovery
Time frame: Baseline, day of surgery, 90 days postoperatively
Change in Health Related Quality of Life Over the Course of Treatment and Recovery
Time frame: Baseline, day of surgery, 30-days postoperatively, 90-days postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Daniel E. Hall, MD MDiv MHSc principal investigator
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Coronary Artery Bypass Graft and Non-cardiac Thoracic Surgery, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 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 13 Jan 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 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?
Yes. Results are posted in the registry (first posted 21 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recruitment Rate (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.