FrailtyNCT04500366
GERAS Frailty Rehabilitation at Home During COVID-19
A study testing Socialization, Virtual Group Exercise and Nutrition Consult and Protein Supplementation in people with Frailty, run by McMaster University at 1 site in Canada.
Trial summary
The coronavirus disease 2019 (COVID-19) pandemic is keeping people apart, which can take a toll on physical and mental health. Many healthcare professionals are concerned vulnerable seniors may become deconditioned, which substantially increases risk of health complications and need for hospitalization. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Socialization, Virtual Group Exercise and Nutrition Consult and Protein Supplementation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 26 Aug 2020to 1 Nov 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Community-dwelling adults aged ≥ 65 years of age;
- Score between 4-6 (inclusive) on the clinical frailty scale;
- Able to ambulate independently with or without a walking aid; OR with caregiver supervision at home;
- Obtain clearance for exercise: For hospital referrals - average resting heart rate between 50-100 bpm and average blood pressure less than or equal to 160/90mmHg (as per Canadian Society for Exercise Physiology guidelines for exercise clearance); OR Self- referrals: Obtain exercise clearance from their family physician prior to the first intervention session.
Who cannot join
- Unable to speak or understand English and has no caregiver for translation;
- Significant cognitive impairment where they may have difficulty following two-step commands;
- Receiving palliative/end of life care;
- Unstable angina or unstable heart failure;
- Travel plans that would result in missing greater than 20% of the trial's 12-week duration;
- Currently attending a group exercise program.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster University - Hamilton Health Sciences (St. Peter's Site)
Hamilton, Ontario, L8M1W9
About this study
Official title: GERAS Frailty Rehabilitation at Home: Virtual Bundled Care for Seniors Who Are Frail to Build Strength and Resilience During COVID-19
The coronavirus disease 2019 (COVID-19) pandemic is keeping people apart, which can take a toll on physical and mental health. Many healthcare professionals are concerned vulnerable seniors may become deconditioned, which substantially increases risk of health complications and need for hospitalization. To address the immediate impact of COVID-19 policies (i.e., physical distancing, reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors. The investigators' aim is to understand how to best build resilience among vulnerable seniors in the community through at-home rehabilitation services (socialization, exercise, nutrition, and medication support).
Read the detailed description
During this unprecedented time of COVID-19, many healthcare professionals are concerned that vulnerable seniors who are housebound and isolated will become deconditioned resulting in functional losses in mental status, continence and ability to complete activities of daily living. Total inactivity in seniors can result in a 10-20% decrease in muscle strength per week (1 -3% per day). Loss of muscle strength may quickly convert a vulnerable older adult who was ambulatory into a bedridden state. This will affect the health of seniors and increase demand on healthcare systems. An innovative model to deliver frailty rehabilitation services remotely is urgently needed to: 1) increase access to specialized services 2) provide added supports for seniors discharged from the hospital who are in need of rehabilitation and 3) build resilience in seniors to prevent re-hospitalization or institutionalization. Therefore, to address the immediate impact of COVID-19 policies (i.e., physical distancing and reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors. This proof-of-concept, randomized control trial aims to understand how to best build resilience among vulnerable seniors through at-home rehabilitation services using socialization, exercise, nutrition, and medication support.
The short-term immediate goals for this RCT are to help vulnerable seniors who are isolated because of physical distancing measures to build strength and resilience throughout the COVID-19 pandemic. The major deliverables are 1) the adaptation of an in-person program to virtual delivery 2) the piloting of a care pathway with inter-disciplinary professionals that can be expanded to reach a larger number of individuals.
The long-term goal of the study is the seamless implementation of a new model for multimodal Frailty Rehabilitation that closes the care gap in rehabilitation for frail seniors in the immediate and foreseeable future.
- Conditions
- Frailty
- Being tested
- Socialization, Virtual Group Exercise, Nutrition Consult and Protein Supplementation, Medication Review
- Keywords
- Rehabilitation, Frailty, COVID-19, Exercise, Protein, Medication
- Medical subject headings
- Frailty, COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SocializationBehavioural
Social interaction is associated with better mental and physical health, and evidence suggests that group versus individual engagement may offer unique cognitive benefits for older adults as well as peer reinforcement and encouragement.
Virtual Group ExerciseBehavioural
Participants will receive twice-weekly (one hour per class) virtual exercise via small-group physiotherapy sessions for a total of 12 weeks. All exercise sessions will occur virtually via a videoconferencing system. The classes will focus on functional movements specifically designed for seniors with frailty and mobility challenges, and will include modifications for gait aids such as canes or walkers. Class sizes will be small to allow for tailoring of exercises based on challenging, safe, progressive, evidence-based exercises. In accordance with recent guidelines to achieve 3 hours/week for fall prevention practice in older adults, participants will also be provided with tailored supplemental home exercises developed by the study physiotherapist to gain an additional 1 hour of physical activity.
Nutrition Consult and Protein SupplementationCombination product
Nutrition Consult: Participants will be scheduled for a one-on-one virtual nutrition consult. During the consultation, study staff will assess the nutritional status of the participant and will provide them with counselling and coaching to improve their nutrition.
Protein Supplementation: Oral nutrition supplements commercially available from Nestle will be provided unless contraindicated. The oral nutrition supplement contains 360 calories and 14 grams of protein per serving. Participants are advised to take this with a meal or within 3 hours of exercise on activity days.
Medication ReviewBehavioural
A study pharmacist will review the participant's medication list and will utilize Beers and/or START/STOPP criteria to provide recommendations to optimize/update their medications to the participant's healthcare provider. Study geriatricians will be listed as contacts on the primary care provider recommendations and available for consultation.
| Study group | Role | What they receive |
|---|---|---|
| Socialization | Active comparator | Participants randomized to the socialization arm will receive once-weekly phone calls from medical student volunteers for a total of 12-weeks (n=35). This program pairs health professional student volunteers with older adults in the community to provide social comfort while heightened physical distancing measures are in place during the current COVID-19 pandemic. Attendance and duration of the phone calls will be logged. Receives: Behavioral: Socialization |
| Multi-Modal Frailty Rehabilitation | Experimental | Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all through a videoconferencing system. Receives: Behavioral: Socialization; Behavioral: Virtual Group Exercise; Combination Product: Nutrition Consult and Protein Supplementation; Behavioral: Medication Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Function
Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.
Measured: Baseline and 12 Weeks Post-Intervention
Change in Mental Health
Assessed by the Depression Anxiety Stress Scale (DASS-21). Higher scores indicate greater risk of depression, anxiety and stress [depression, anxiety, stress subscores range 0-21].
Measured: Baseline and 12 Weeks Post-Intervention
Secondary outcomes (12)
Change in Sarcopenia
Assessed by the SARC-F - Self-reported strength, assistance with walking, rising from a chair, climbing stairs and falls. Higher scores indicate greater level of sarcopenia [range 0-10].
Measured: Baseline and 12 Weeks Post-Intervention
Change in Frailty
Assessed by the Fit-Frailty Index. Higher scores indicate greater degree of frailty [range 0-1].
Measured: Baseline and 12 Weeks Post-Intervention
Change in Self-Efficacy
Balance confidence will be assessed using the Activities-specific Balance Confidence Scale (ABCs). Higher scores indicate greater balance confidence [range 0-100].
Measured: Baseline and 12 Weeks Post-Intervention
Self-Reported Change in Function, Health and Well-Being
Assessed by the interRAI Community Rehab Assessment - Self-Report
Measured: Baseline and 12 Weeks Post-Intervention
Clinician-Reported Change in Function, Health and Well-Being
Assessed by the interRAI Community Rehab Assessment - Clinician-Completed
Measured: Baseline and 12 Weeks Post-Intervention
Change in Fitness
Assessed by the Borg Rate of Perceived Exertion after exercise. Higher scores indicate greater level of exertion [range 6-20]. Also assessed using accelerometers (heart rate, sedentary time, physical activity time, energy expenditure).
Measured: Weekly up to 12 weeks
Program Satisfaction
Assessed using a program questionnaire in accordance with the Kirkpatrick 5-Level Evaluation Model. Scores will be on a 5-point Likert scale ranging from "Strongly Disagree" to "Strongly Agree".
Measured: 12 Weeks Post-Intervention
Change in Health-Related Quality of Life
Assessed by the EQ-5D-5L scale. Lower scores indicate better self-reported quality of life [range 0-100].
Measured: Baseline and 12 Weeks Post-Intervention
Change in Nutrition
Assessed by the Subjective Global Assessment. Grades range from A-C where 'A' represents normal nutrition and 'C' represents severe malnourishment.
Measured: Baseline and 12 Weeks Post-Intervention
Change in Emergency Room Visits
Number of emergency room visits will be recorded. Higher number of emergency room visits indicates higher healthcare utilization.
Measured: Baseline and 12 Weeks Post-Intervention
Change in Hospitalizations
Number of hospitalizations will be recorded. Higher number of hospitalizations indicates higher healthcare utilization.
Measured: Baseline and 12 Weeks Post-Intervention
Change in Number of Calls to 911
Number of calls to 911 will be recorded. Higher number of calls indicates higher healthcare utilization.
Measured: Baseline and 12 Weeks Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start26 Aug 2020
- Primary completion1 Nov 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two arms (35/arm based on sample size calculation) for 12-weeks of socialization only or multi-modal frailty rehabilitation. The socialization only arm will receive 1x/week phone calls from medical student volunteers. Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all via a videoconferencing service.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandra Papaioannou, McMaster University
- Investigators
- Alexandra Papaioannou, MD, MSc, Principal investigator, Scientific Director, GERAS Centre for Aging Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500366
- Sponsor's protocol ID
- 11408
- Status last verified
- Mar 2022
- First submitted
- 31 Jul 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Okpara C, Ioannidis G, Thabane L, Adachi JD, Rabinovich A, Hewston P, Lee J, McArthur C, Kennedy C, Woo T, Boulos P, Bobba R, Wang M, Thrall S, Mangin D, Marr S, Armstrong D, Patterson C, Bray S, de Wit K, Maharaj S, Misiaszek B, Sookhoo JB, Thompson K, Papaioannou A. The Geras virtual frailty rehabilitation program to build resilience in older adults with frailty during COVID-19: a randomized feasibility trial. Pilot Feasibility Stud. 2023 Jul 17;9(1):124. doi: 10.1186/s40814-023-01346-7.
PubMed 37461117
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GERAS Frailty Rehabilitation at Home: Virtual Bundled Care for Seniors Who Are Frail to Build Strength and Resilience During COVID-19
- ClinicalTrials.gov ID
- NCT04500366
- Acronym / sponsor ID
- 11408
- Conditions
- Frailty
- Keywords
- Rehabilitation, Frailty, COVID-19, Exercise, Protein, Medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 5 Aug 2020 (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.
The coronavirus disease 2019 (COVID-19) pandemic is keeping people apart, which can take a toll on physical and mental health. Many healthcare professionals are concerned vulnerable seniors may become deconditioned, which substantially increases risk of health complications and need for hospitalization. To address the immediate impact of COVID-19 policies (i.e., physical distancing, reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors. The investigators' aim is to understand how to best build resilience among vulnerable seniors in the community through at-home rehabilitation services (socialization, exercise, nutrition, and medication support).
Detailed description
During this unprecedented time of COVID-19, many healthcare professionals are concerned that vulnerable seniors who are housebound and isolated will become deconditioned resulting in functional losses in mental status, continence and ability to complete activities of daily living. Total inactivity in seniors can result in a 10-20% decrease in muscle strength per week (1 -3% per day). Loss of muscle strength may quickly convert a vulnerable older adult who was ambulatory into a bedridden state. This will affect the health of seniors and increase demand on healthcare systems. An innovative model to deliver frailty rehabilitation services remotely is urgently needed to: 1) increase access to specialized services 2) provide added supports for seniors discharged from the hospital who are in need of rehabilitation and 3) build resilience in seniors to prevent re-hospitalization or institutionalization. Therefore, to address the immediate impact of COVID-19 policies (i.e., physical distancing and reduced access to care), the GERAS Frailty Rehabilitation model will be adapted to be delivered remotely in the homes of vulnerable seniors. This proof-of-concept, randomized control trial aims to understand how to best build resilience among vulnerable seniors through at-home rehabilitation services using socialization, exercise, nutrition, and medication support.
The short-term immediate goals for this RCT are to help vulnerable seniors who are isolated because of physical distancing measures to build strength and resilience throughout the COVID-19 pandemic. The major deliverables are 1) the adaptation of an in-person program to virtual delivery 2) the piloting of a care pathway with inter-disciplinary professionals that can be expanded to reach a larger number of individuals.
The long-term goal of the study is the seamless implementation of a new model for multimodal Frailty Rehabilitation that closes the care gap in rehabilitation for frail seniors in the immediate and foreseeable future.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two arms (35/arm based on sample size calculation) for 12-weeks of socialization only or multi-modal frailty rehabilitation. The socialization only arm will receive 1x/week phone calls from medical student volunteers. Multi-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all via a videoconferencing service.
| Arm | Type | Receives |
|---|---|---|
| Socialization | Active comparator | Behavioral: SocializationParticipants randomized to the socialization arm will receive once-weekly phone calls from medical student volunteers for a total of 12-weeks (n=35). This program pairs health professional student volunteers with older adults in the community to provide social comfort while heightened physical distancing measures are in place during the current COVID-19 pandemic. Attendance and duration of the phone calls will be logged. |
| Multi-Modal Frailty Rehabilitation | Experimental | Behavioral: Socialization, Behavioral: Virtual Group Exercise, Combination Product: Nutrition Consult and Protein Supplementation, Behavioral: Medication ReviewMulti-modal frailty rehabilitation will involve virtual care including 1x/week socialization, 2x/week exercise (small group physiotherapy live-streamed sessions), nutrition (virtual consult), and medication support (virtual pharmacist consult) all through a videoconferencing system. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Community-dwelling adults aged ≥ 65 years of age;
- Score between 4-6 (inclusive) on the clinical frailty scale;
- Able to ambulate independently with or without a walking aid; OR with caregiver supervision at home;
- Obtain clearance for exercise: For hospital referrals - average resting heart rate between 50-100 bpm and average blood pressure less than or equal to 160/90mmHg (as per Canadian Society for Exercise Physiology guidelines for exercise clearance); OR Self- referrals: Obtain exercise clearance from their family physician prior to the first intervention session.
Key exclusion criteria (6 listed)
- Unable to speak or understand English and has no caregiver for translation;
- Significant cognitive impairment where they may have difficulty following two-step commands;
- Receiving palliative/end of life care;
- Unstable angina or unstable heart failure;
- Travel plans that would result in missing greater than 20% of the trial's 12-week duration;
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 |
|---|---|---|
| SocializationSocial interaction is associated with better mental and physical health, and evidence suggests that group versus individual engagement may offer unique cognitive benefits for older adults as well as peer reinforcement and encouragement. | Behavioural | Multi-Modal Frailty Rehabilitation, Socialization |
| Virtual Group ExerciseParticipants will receive twice-weekly (one hour per class) virtual exercise via small-group physiotherapy sessions for a total of 12 weeks. All exercise sessions will occur virtually via a videoconferencing system. The classes will focus on functional movements specifically designed for seniors with frailty and mobility challenges, and will include modifications for gait aids such as canes or walkers. Class sizes will be small to allow for tailoring of exercises based on challenging, safe, progressive, evidence-based exercises. In accordance with recent guidelines to achieve 3 hours/week for fall prevention practice in older adults, participants will also be provided with tailored supplemental home exercises developed by the study physiotherapist to gain an additional 1 hour of physical activity. | Behavioural | Multi-Modal Frailty Rehabilitation |
| Nutrition Consult and Protein SupplementationNutrition Consult: Participants will be scheduled for a one-on-one virtual nutrition consult. During the consultation, study staff will assess the nutritional status of the participant and will provide them with counselling and coaching to improve their nutrition. Protein Supplementation: Oral nutrition supplements commercially available from Nestle will be provided unless contraindicated. The oral nutrition supplement contains 360 calories and 14 grams of protein per serving. Participants are advised to take this with a meal or within 3 hours of exercise on activity days. | Combination product | Multi-Modal Frailty Rehabilitation |
| Medication ReviewA study pharmacist will review the participant's medication list and will utilize Beers and/or START/STOPP criteria to provide recommendations to optimize/update their medications to the participant's healthcare provider. Study geriatricians will be listed as contacts on the primary care provider recommendations and available for consultation. | Behavioural | Multi-Modal Frailty Rehabilitation |
Primary outcome
Change in Physical Function
Time frame: Baseline and 12 Weeks Post-Intervention
Assessed by the 5x Sit-to-Stand (time to complete). Faster times to complete indicate better performance.
Change in Mental Health
Time frame: Baseline and 12 Weeks Post-Intervention
Assessed by the Depression Anxiety Stress Scale (DASS-21). Higher scores indicate greater risk of depression, anxiety and stress [depression, anxiety, stress subscores range 0-21].
12 secondary outcomes
Change in Sarcopenia
Time frame: Baseline and 12 Weeks Post-Intervention
Change in Frailty
Time frame: Baseline and 12 Weeks Post-Intervention
Change in Self-Efficacy
Time frame: Baseline and 12 Weeks Post-Intervention
Self-Reported Change in Function, Health and Well-Being
Time frame: Baseline and 12 Weeks Post-Intervention
Clinician-Reported Change in Function, Health and Well-Being
Time frame: Baseline and 12 Weeks Post-Intervention
Change in Fitness
Time frame: Weekly up to 12 weeks
Program Satisfaction
Time frame: 12 Weeks Post-Intervention
Change in Health-Related Quality of Life
Time frame: Baseline and 12 Weeks Post-Intervention
Change in Nutrition
Time frame: Baseline and 12 Weeks Post-Intervention
Change in Emergency Room Visits
Time frame: Baseline and 12 Weeks Post-Intervention
Change in Hospitalizations
Time frame: Baseline and 12 Weeks Post-Intervention
Change in Number of Calls to 911
Time frame: Baseline and 12 Weeks Post-Intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Derived from this study: PubMed 37461117Okpara C, Ioannidis G, Thabane L, Adachi JD, Rabinovich A, Hewston P, Lee J, McArthur C, Kennedy C, Woo T, Boulos P, Bobba R, Wang M, Thrall S, Mangin D, Marr S, Armstrong D, Patterson C, Bray S, de Wit K, Maharaj S, Misiaszek B, Sookhoo JB, Thompson K, Papaioannou A. The Geras virtual frailty rehabilitation program to build resilience in older adults with frailty during COVID-19: a randomized feasibility trial. Pilot Feasibility Stud. 2023 Jul 17;9(1):124. doi: 10.1186/s40814-023-01346-7.
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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.
Alexandra Papaioannou, MD, MSc principal investigator
Scientific Director, GERAS Centre for Aging Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socialization, Virtual Group Exercise and Nutrition Consult and Protein Supplementation in people with Frailty, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 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 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Function (time frame: Baseline and 12 Weeks Post-Intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04500366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.