Surgical PatientsNCT04155346
Prehab for Surgery
A study testing Exercise, nutritional optimization, and psychoeducation in people with Surgical Patients and Preoperative Care, run by University of Toronto at 1 site in Canada.
Trial summary
Surgical prehabilitation is the process of enhancing one's physical function and mental capacity to enable him/or her to withstand the stressor of surgery. Prehabilitation can be achieved via optimizing physical fitness, nutrition, and psychological health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Patients, Preoperative Care
- What is being tested?
- Exercise, nutritional optimization, and psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2019to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned for surgery at the University Health Network
- Fluent in English
- Referred by their surgeon with indication for prehabilitation as per the surgeon's clinical impression (i.e. higher-than-average risk candidate; marginal candidate for surgery due to limited physiologic reserve; frail; deconditioned; or other reason with explanation.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Effectiveness of Prehabilitation in High-risk Surgical Patients
Surgical prehabilitation is the process of enhancing one's physical function and mental capacity to enable him/or her to withstand the stressor of surgery. Prehabilitation can be achieved via optimizing physical fitness, nutrition, and psychological health. Studies have shown that prehabilitation may prevent complications during and after surgery, reduce hospital length of stay, and improve postoperative recovery. Despite the growing interest in the field of prehabilitation, little is understood about how to implement prehabilitation an integrated clinical service. This study will examine the effect of a prehabilitation program that includes exercise, psychological, and nutritional optimization that emulates clinical integration pathways. Participants of this study will have a choice of participating in facility-based prehabilitation (FBP) or home-based prehabilitation (HBP) depending on their needs/accessibility to the Toronto General Hospital. Participant outcomes will be measured using standardized fitness testing, self-report questionnaires, and medical record reviews at baseline, one week preoperatively, and at 30 and 90 days postoperatively. A comprehensive assessment of feasibility will also be conducted to better understand facilitators and barriers to clinical integration.
Read the detailed description
There is growing interest in the role of prehabilitation to reduce surgical risk, attenuate surgery-related deconditioning, and facilitate postoperative recovery. Compared to the postoperative setting, initiating health interventions preoperatively is proposed as an important strategy to improve health outcomes because: i) it targets modifiable risk factors for surgical complications; ii) patients may be more physically and/or psychologically capable of affecting change in health status compared to the early postoperative period; iii) wait times prior to surgery may be several weeks thus representing an opportunity to proactively invest in their recovery; and iv) patients may be sensitized to the importance of adverse health behaviours that may have contributed to the need for surgery (i.e. a 'teachable moment'). The potential benefit of prehabilitation extends beyond potential gains in health from baseline to surgery, but also includes the prevention or attenuation of deconditioning that patients experience during the postoperative period. The findings of recent systematic reviews and meta-analyses assessing the benefits of prehabilitation interventions in surgical patients provide support for their efficacy in improving physical fitness, length of stay, surgical complication rates, and health-related quality of life (HRQOL).
While previous interventional studies have demonstrated promising findings, little is known about how feasible it is to integrate prehabilitation into standard of care for people awaiting surgery. This study intends to employ intervention design features previously shown to be feasible and efficacious and employs a hybrid effectiveness-implementation trial design model to assess feasibility of clinical integration.
- Conditions
- Surgical Patients, Preoperative Care
- Being tested
- Exercise, nutritional optimization, and psychoeducation
- Keywords
- Exercise, Nutrition, Psychology, Prehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise, nutritional optimization, and psychoeducationBehavioural
Multimodal prehabilitation including exercise, nutrition, and stress-management delivered via a facility-based or home-based model
| Study group | Role | What they receive |
|---|---|---|
| Facility-based prehabilitation (FBP) | Experimental | Exercise
* Three supervised exercise training sessions of aerobic and resistance exercises. Includes high-intensity interval aerobic training and whole-body resistance exercises (60 min/session)
* Specific exercises will also be prescribed to prepare regional and/or compensatory tissues for surgery
* Exercise session will be supervised by a Registered Kinesiologist/Exercise Physiologist
Nutrition
* Participants will receive an individualized nutrition assessment and counselling within the first week of prehabilitation and again in the week prior to surgery
* All sessions will conducted by a Registered Dietitian (60 min/session)
* Participants will also receive 20g of protein supplementation daily
Stress management and behavioural support
* Participants will be scheduled for a psychoeducation session within the first week of prehabilitation and again in the week prior to surgery
* All sessions will conducted by a psychologist (60 min/session) Receives: Behavioral: Exercise, nutritional optimization, and psychoeducation |
| Home-based prehabilitation (HBP) | Experimental | Exercise
* Three unsupervised, home-based exercise training sessions of aerobic and resistance exercises. Includes continuous moderate-intensity aerobic training and whole-body resistance exercises (60 min/session)
* Specific exercises will also be prescribed to prepare regional and/or compensatory tissues for surgery
* Exercise session will be supervised by a Registered Kinesiologist/Exercise Physiologist
Nutrition
* Participants will receive an individualized nutrition assessment and counselling within the first week of prehabilitation and again in the week prior to surgery
* All sessions will conducted by a Registered Dietitian (60 min/session)
* Participants will also receive 20g of protein supplementation daily
Stress management and behavioural support
* Participants will be scheduled for a psychoeducation session within the first week of prehabilitation and again in the week prior to surgery
* All sessions will conducted by a psychologist (60 min/session) Receives: Behavioral: Exercise, nutritional optimization, and psychoeducation |
| Usual Care | No intervention | - This group will receive no additional intervention from the routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Referral and Enrollment Data
- The number of eligible patients per month who consent for surgery will be ascertained via the preadmission clinic databases.
- The total number of referrals received from surgeons.
- The number of patients that agree to participate in the prehabilitation program.
- Demographics, disease characteristics, and treatment type will be captured for prehabilitation participants
- Referred patients who decline participation in the study will be compared to all consenting participants using information provided on the referral form
- For those who fail screening or decline participation, we will log their demographic and reasons for non-participation.
Measured: Baseline
Window of opportunity
The 'prehabilitation window' will be recorded and is operationally defined as the time from program referral to the date of surgery. We will also describe the total preoperative period (time between consent for surgery and date of surgery) and prehabilitation program duration (time from program initiation to surgery). Each of these periods will be recorded in days.
Measured: Baseline to surgery
Intervention adherence and fidelity
- Adherence for FBP participants will be recorded via attendance to each in-person session. Fidelity and adherence will be further measured by detailed recording of performance on the aerobic and resistance training components of the exercise sessions.
- HBP participants will be contacted weekly via telephone or email for adherence recording by the research coordinator. A logbook will be used to self-report HBP participants' home-based exercise that contains specific fields to capture all session details.
- Adherence to stress management and utilization of smoking cessation tools (as required) will be recorded weekly using a logbook within the participant manuals. This includes the number of relaxation sessions per week; compliance with dietary recommendations for dietary behaviours, protein supplementation, and for smokers, the tools used, and the number of times accessed.
Measured: Baseline to surgery
Study retention
- The frequency of drop-out during program participation will be documented including reasons for drop-out. Descriptive statistics for demographic data and reasons will be used to describe program completers and drop-outs.
Measured: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Barriers and facilitators
Qualitative content analysis on barriers and facilitators for prehabilitation participation and engagement will be conducted using semi-structured interviews. Both participants of prehabilitation and usual care will be asked to participate in interviews via telephone or in-person. To reach saturation for identifying meta-themes within a heterogenous population, sample of has been suggested 15 for the collection of prevalent and more salient ideas.
Measured: 30-day postoperatively
Safety and adverse events
Any safety or adverse events related to the prehabilitation intervention will be reported at each in-person session for FBP participants and during weekly telephone calls with HBP participants. Reporting and grading will follow the Common Terminology Criteria for Adverse Events version 5.0.
Measured: Baseline to surgery
Economic feasibility (hospital perspective)
A cost impact on the perspective of the hospital will be conducted based on primary hospital length of stay, readmission, and readmission length of stay. This will be used to determine cost differences between those that participate in prehabilitation (FBP and HBP) compared to usual care.
Measured: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Economic feasibility (patient perspective)
Patient-perspective costing will be measured by a patient-reported cost-diary. This includes: direct healthcare cost (i.e. visits to the general practice, specialists care, unities applied to prescribed medication); direct non-health care costs (i.e. cost of over-the-counter medication, cost of health activities, hours of paid and unpaid household help, transportation, and value of other out-of-pocket expenses, with specifics on exercise-related expenses)l and indirect costs (i.e. number of days absent from work, days lost from housekeeping, and other daily activities).
Measured: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Secondary outcomes (8)
Hospital length of stay
Postoperative length of stay will be recorded from the patient's medical record. This will be calculated from the date of surgery until to the date of discharge from the hospital and recorded in hours.
Measured: Up to 90-days postoperatively
Postoperative complications and mortality
Complications, including mortality, will follow the Clavien-Dindo classification. Any health event that requires readmission will also be documented.
Measured: Up to 90-days postoperatively
Changes in aerobic functional capacity
Aerobic functional capacity will be measured using the Six-Minute Walk Test (6MWT). Total distance travelled for 6 minutes will be recorded. Measured only in participants of prehabilitation.
Measured: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Changes in musculoskeletal functional capacity
Musculoskeletal functional capacity will be assessed via grip strength. Peak isometric force generated for both arms will be recorded in kg-force. Measured only in participants of prehabilitation.
Measured: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Changes in body composition
Body composition will be measured via bioelectric impedance analysis using mBCA 514 (Seca, Hamburg, Germany). Body fat percentage, fat and fat free mass, impedance, resistance, and phase angle will be recorded. Measured only in participants of prehabilitation.
Measured: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Changes in HRQOL
HRQOL will be measured by Short Form-12 Health Survey (SF-12) and the EuroQol-5 Dimension (EQ5D). Measured only in participants of prehabilitation.
Measured: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Changes in depression
Depression will be assessed using the Patient Health Questionnaire (PHQ-9). Measured only in participants of prehabilitation.
Measured: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Changes in diet
Changes in diet and healthy eating practices will be measured by the 3-day diet record. Measured only in participants of prehabilitation.
Measured: Baseline and 1 week prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Nov 2019
- Primary completion1 Mar 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical PatientsStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Effectiveness-Implementation hybrid model
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, MSH-UHN AMO Innovation Fund
- Responsible party
- Principal investigator, Daniel Santa Mina, PhD, University of Toronto
- Investigators
- Daniel Santa Mina, PhD, Principal investigator, University of TorontoIan Randall, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155346
- Sponsor's protocol ID
- 19-5573
- Status last verified
- May 2024
- First submitted
- 30 Oct 2019
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Prehabilitation in High-risk Surgical Patients
- ClinicalTrials.gov ID
- NCT04155346
- Acronym / sponsor ID
- 19-5573
- Conditions
- Surgical Patients, Preoperative Care
- Keywords
- Exercise, Nutrition, Psychology, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, MSH-UHN AMO Innovation Fund
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical prehabilitation is the process of enhancing one's physical function and mental capacity to enable him/or her to withstand the stressor of surgery. Prehabilitation can be achieved via optimizing physical fitness, nutrition, and psychological health. Studies have shown that prehabilitation may prevent complications during and after surgery, reduce hospital length of stay, and improve postoperative recovery. Despite the growing interest in the field of prehabilitation, little is understood about how to implement prehabilitation an integrated clinical service. This study will examine the effect of a prehabilitation program that includes exercise, psychological, and nutritional optimization that emulates clinical integration pathways. Participants of this study will have a choice of participating in facility-based prehabilitation (FBP) or home-based prehabilitation (HBP) depending on their needs/accessibility to the Toronto General Hospital. Participant outcomes will be measured using standardized fitness testing, self-report questionnaires, and medical record reviews at baseline, one week preoperatively, and at 30 and 90 days postoperatively. A comprehensive assessment of feasibility will also be conducted to better understand facilitators and barriers to clinical integration.
Detailed description
There is growing interest in the role of prehabilitation to reduce surgical risk, attenuate surgery-related deconditioning, and facilitate postoperative recovery. Compared to the postoperative setting, initiating health interventions preoperatively is proposed as an important strategy to improve health outcomes because: i) it targets modifiable risk factors for surgical complications; ii) patients may be more physically and/or psychologically capable of affecting change in health status compared to the early postoperative period; iii) wait times prior to surgery may be several weeks thus representing an opportunity to proactively invest in their recovery; and iv) patients may be sensitized to the importance of adverse health behaviours that may have contributed to the need for surgery (i.e. a 'teachable moment'). The potential benefit of prehabilitation extends beyond potential gains in health from baseline to surgery, but also includes the prevention or attenuation of deconditioning that patients experience during the postoperative period. The findings of recent systematic reviews and meta-analyses assessing the benefits of prehabilitation interventions in surgical patients provide support for their efficacy in improving physical fitness, length of stay, surgical complication rates, and health-related quality of life (HRQOL).
While previous interventional studies have demonstrated promising findings, little is known about how feasible it is to integrate prehabilitation into standard of care for people awaiting surgery. This study intends to employ intervention design features previously shown to be feasible and efficacious and employs a hybrid effectiveness-implementation trial design model to assess feasibility of clinical integration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Effectiveness-Implementation hybrid model
| Arm | Type | Receives |
|---|---|---|
| Facility-based prehabilitation (FBP) | Experimental | Behavioral: Exercise, nutritional optimization, and psychoeducationExercise * Three supervised exercise training sessions of aerobic and resistance exercises. Includes high-intensity interval aerobic training and whole-body resistance exercises (60 min/session) * Specific exercises will also be prescribed to prepare regional and/or compensatory tissues for surgery * Exercise session will be supervised by a Registered Kinesiologist/Exercise Physiologist Nutrition * Participants will receive an individualized nutrition assessment and counselling within the first week of prehabilitation and again in the week prior to surgery * All sessions will conducted by a Registered Dietitian (60 min/session) * Participants will also receive 20g of protein supplementation daily Stress management and behavioural support * Participants will be scheduled for a psychoeducation session within the first week of prehabilitation and again in the week prior to surgery * All sessions will conducted by a psychologist (60 min/session) |
| Home-based prehabilitation (HBP) | Experimental | Behavioral: Exercise, nutritional optimization, and psychoeducationExercise * Three unsupervised, home-based exercise training sessions of aerobic and resistance exercises. Includes continuous moderate-intensity aerobic training and whole-body resistance exercises (60 min/session) * Specific exercises will also be prescribed to prepare regional and/or compensatory tissues for surgery * Exercise session will be supervised by a Registered Kinesiologist/Exercise Physiologist Nutrition * Participants will receive an individualized nutrition assessment and counselling within the first week of prehabilitation and again in the week prior to surgery * All sessions will conducted by a Registered Dietitian (60 min/session) * Participants will also receive 20g of protein supplementation daily Stress management and behavioural support * Participants will be scheduled for a psychoeducation session within the first week of prehabilitation and again in the week prior to surgery * All sessions will conducted by a psychologist (60 min/session) |
| Usual Care | No intervention | –- This group will receive no additional intervention from the routine care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Planned for surgery at the University Health Network
- Fluent in English
- Referred by their surgeon with indication for prehabilitation as per the surgeon's clinical impression (i.e. higher-than-average risk candidate; marginal candidate for surgery due to limited physiologic reserve; frail; deconditioned; or other reason with explanation.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Exercise, nutritional optimization, and psychoeducationMultimodal prehabilitation including exercise, nutrition, and stress-management delivered via a facility-based or home-based model | Behavioural | Facility-based prehabilitation (FBP), Home-based prehabilitation (HBP) |
Primary outcome
Referral and Enrollment Data
Time frame: Baseline
* The number of eligible patients per month who consent for surgery will be ascertained via the preadmission clinic databases. * The total number of referrals received from surgeons. * The number of patients that agree to participate in the prehabilitation program. * Demographics, disease characteristics, and treatment type will be captured for prehabilitation participants * Referred patients who decline participation in the study will be compared to all consenting participants using information provided on the referral form * For those who fail screening or decline participation, we will log their demographic and reasons for non-participation.
Window of opportunity
Time frame: Baseline to surgery
The 'prehabilitation window' will be recorded and is operationally defined as the time from program referral to the date of surgery. We will also describe the total preoperative period (time between consent for surgery and date of surgery) and prehabilitation program duration (time from program initiation to surgery). Each of these periods will be recorded in days.
Intervention adherence and fidelity
Time frame: Baseline to surgery
* Adherence for FBP participants will be recorded via attendance to each in-person session. Fidelity and adherence will be further measured by detailed recording of performance on the aerobic and resistance training components of the exercise sessions. * HBP participants will be contacted weekly via telephone or email for adherence recording by the research coordinator. A logbook will be used to self-report HBP participants' home-based exercise that contains specific fields to capture all session details. * Adherence to stress management and utilization of smoking cessation tools (as required) will be recorded weekly using a logbook within the participant manuals. This includes the number of relaxation sessions per week; compliance with dietary recommendations for dietary behaviours, protein supplementation, and for smokers, the tools used, and the number of times accessed.
Study retention
Time frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
- The frequency of drop-out during program participation will be documented including reasons for drop-out. Descriptive statistics for demographic data and reasons will be used to describe program completers and drop-outs.
Barriers and facilitators
Time frame: 30-day postoperatively
Qualitative content analysis on barriers and facilitators for prehabilitation participation and engagement will be conducted using semi-structured interviews. Both participants of prehabilitation and usual care will be asked to participate in interviews via telephone or in-person. To reach saturation for identifying meta-themes within a heterogenous population, sample of has been suggested 15 for the collection of prevalent and more salient ideas.
Safety and adverse events
Time frame: Baseline to surgery
Any safety or adverse events related to the prehabilitation intervention will be reported at each in-person session for FBP participants and during weekly telephone calls with HBP participants. Reporting and grading will follow the Common Terminology Criteria for Adverse Events version 5.0.
Economic feasibility (hospital perspective)
Time frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
A cost impact on the perspective of the hospital will be conducted based on primary hospital length of stay, readmission, and readmission length of stay. This will be used to determine cost differences between those that participate in prehabilitation (FBP and HBP) compared to usual care.
Economic feasibility (patient perspective)
Time frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Patient-perspective costing will be measured by a patient-reported cost-diary. This includes: direct healthcare cost (i.e. visits to the general practice, specialists care, unities applied to prescribed medication); direct non-health care costs (i.e. cost of over-the-counter medication, cost of health activities, hours of paid and unpaid household help, transportation, and value of other out-of-pocket expenses, with specifics on exercise-related expenses)l and indirect costs (i.e. number of days absent from work, days lost from housekeeping, and other daily activities).
8 secondary outcomes
Hospital length of stay
Time frame: Up to 90-days postoperatively
Postoperative complications and mortality
Time frame: Up to 90-days postoperatively
Changes in aerobic functional capacity
Time frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Changes in musculoskeletal functional capacity
Time frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Changes in body composition
Time frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Changes in HRQOL
Time frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Changes in depression
Time frame: Baseline, 1 week prior to surgery, 30- and 90-day postoperatively
Changes in diet
Time frame: Baseline and 1 week prior to surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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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 Santa Mina, PhD principal investigator
University of Toronto
Ian Randall, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, nutritional optimization, and psychoeducation in people with Surgical Patients and Preoperative Care, run by University of Toronto 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 0 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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?
Results are not available in the source record.
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?
Referral and Enrollment Data (time frame: Baseline). The study lists 8 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 8 May 2024.