FrailtyTARGET-EFTNCT04291690
The TARGET-EFT Randomized Clinical Trial
A study testing Physical Component of the Intervention, Cognitive Component of the Intervention and Nutritional Component of the Intervention in people with Frailty and Cardiovascular Diseases in Old Age, run by Jonathan Afilalo at 1 site in Canada.
Trial summary
Randomized clinical trial to determine whether a multicomponent intervention will lead to improvements in mobility, self-care, mood, pain, and physical activity among frail and pre-frail older adults (as measured with the Essential Frailty Toolset; EFT) hospitalized for an acute cardiovascular illness. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty, Cardiovascular Diseases in Old Age, Geriatric Cardiology
- What is being tested?
- Physical Component of the Intervention, Cognitive Component of the Intervention and Nutritional Component of the Intervention
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteCanada
- Study dates
- 5 Mar 2020to 24 Sep 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
- Age ≥65 years
- Frail or pre-frail as defined by EFT score ≥1
- Admission to the JGH cardiovascular unit
- Signed informed consent
Who cannot join
- Expected discharge within <3 days
- Clinically unstable (unstable vital signs, low-threshold coronary ischemia, uncontrolled heart failure, uncontrolled arrhythmia)
- Awaiting cardiac surgery during the index hospitalization
- Severe dementia (MMSE ≤10/30)
- Delirium (CAM positive)
- Psychiatric condition precluding cooperation
Show all 11Show fewer
- Not English or French speaking
- Parkinson's disease
- Recent stroke <7 days
- Bed-bound or paraplegic
- End-of-life care plan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The TARGET-EFT Trial (MulTicomponent Acute Intervention in FRail GEriatric PaTients With Cardiovascular Disease Using the Essential Frailty Toolset)
Randomized clinical trial to determine whether a multicomponent intervention will lead to improvements in mobility, self-care, mood, pain, and physical activity among frail and pre-frail older adults (as measured with the Essential Frailty Toolset; EFT) hospitalized for an acute cardiovascular illness.
Read the detailed description
The investigators will conduct a single-center randomized clinical trial at the Jewish General Hospital; an academic tertiary care center in Montreal, Quebec. Researchers will pre-screen stable patients ≥65 years of age admitted to the cardiovascular unit. The investigators will target those that consent and have evidence of frailty or pre-frailty according to the EFT (score ≥1/5). The EFT consists of a chair rise test to screen for physical frailty, a mini-cog test to screen for cognitive impairment, a hemoglobin level and a serum albumin level. Patients will be randomly allocated to the usual-care control group, or the intervention group that will receive targeted treatments depending on the EFT deficits identified. All patients will be outfitted with a hip-worn accelerometer to monitor position, step count, and sleep data during the study period. Patients will undergo a structured questionnaire and physical performance assessment at baseline (upon index admission) and at discharge, and will be contacted by telephone 30 days post-discharge to assess their recovery. The primary endpoint will be represented by the EQ-5D scale (mobility, self-care, mood, pain, and physical activity) measured by blinded observers.
- Being tested
- Physical Component of the Intervention, Cognitive Component of the Intervention, Nutritional Component of the Intervention, Iron-Deficiency Anemia (IDA) Component of the Intervention
- Keywords
- Randomized Clinical Trial, Frailty, Intervention
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Component of the InterventionOther
We will encourage and assist patients to walk around the ward as tolerated and approved by their treating clinicians, to maximize the time spent out of bed, minimize the time spent in bed, and to encourage and assist them to perform chair rises to build lower extremity strength. For selected intervention patients with greater physical weakness, defined as SPPB ≤9, a Certified Exercise Physiologist will administer a supervised multicomponent exercise program combining strength, flexibility, balance and gait for the prevention of weakness and falls. The exercise program is adapted from the Vivifrail program which is an EU-funded initiative that provides a guide to prevent frailty, physical deconditioning, and incident disability in older persons. The program includes two daily sessions, one in the morning and one in the afternoon, for a duration of 20 minutes each. The morning session includes strength and flexibility exercises. The afternoon session targets balance and walking.
Cognitive Component of the InterventionOther
We will encourage and assist them to wear their hearing and visual aids (if they have these), orient them to time and place verbally and in writing on a clearly visible white-board in their hospital room - and also encourage their family members and caregivers to do so on a regular basis, and inquire about their sleep quality and communicate with the clinical team to reduce sleep disturbances. For selected intervention patients with greater cognitive impairments, defined as MMSE ≤26, we will provide cognitive simulation twice daily during the scheduled visits. Cognitive stimulation comprises of activities with the patient, including but not limited to current news, trivia, crossword puzzles, and memory games. These cognitive interventions are adapted from the Hospital Elder Life Program (HELP) that targets risk factors for delirium.
Nutritional Component of the InterventionOther
We will reinforce proper eating habits, encourage and assist patients to wear their dentures (if they have these), and inquire about their food preferences and eating barriers and communicate with the clinical dieticians to address these issues. For selected intervention patients with greater nutritional deficits, defined as a positive PONS, we will recommend to the treating clinicians to prescribe MedPass supplementation. PONS, developed as a preoperative screening tool but also used in nonoperative medical settings, reflects low body mass index, weight loss, low dietary intake, and albumin level. MedPass is a 60 mL calorically dense (2 kcal/mL) oral nutritional supplement consumed between meals 4 times per daily. If MedPass supplementation is contraindicated, the treating team will have the full discretion not to prescribe it and/or to consider alternative supplementation strategies.
Iron-Deficiency Anemia (IDA) Component of the InterventionOther
We will verify their clinical blood test results for hemoglobin level and iron studies and apply the diagnostic criteria for iron deficiency as recommended by the Canadian Cardiovascular Society Guidelines for Heart Failure. These criteria are: (i) Hemoglobin <130g/L in men or <120g/L in women with (ii) a Ferritin <100μg/L or a Ferritin <300μg/L with a Saturation <20%. For selected intervention patients with diagnosed iron deficiency anemia, according to these established criteria, we will recommend to the treating clinicians to prescribe Venofer intravenous iron replacement therapy. The use of intravenous iron replacement therapy is a Strong Recommendation in the Canadian Cardiovascular Society Guidelines. Venofer is prescribed at a dosage of 300 mg IV daily for a total of 3 doses. If Venofer supplementation is contraindicated, the treating team will have the full discretion not to prescribe it and/or to consider alternative strategies.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Usual clinical care as prescribed by their treating clinicians; which may or may not include physiotherapy, geriatric consultation, nutritional consultation and supplementation, and treatment of anemia. |
| Intervention Group | Experimental | Multi-component intervention in addition to usual care; which may include - in a targeted fashion - physical training for those with physical weakness, cognitive stimulation for those with cognitive impairment, oral nutritional supplementation for those with malnutrition, and intravenous iron replacement therapy for those with iron deficiency anemia. Receives: Other: Physical Component of the Intervention; Other: Cognitive Component of the Intervention; Other: Nutritional Component of the Intervention; Other: Iron-Deficiency Anemia (IDA) Component of the Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health-related quality of life: EQ-5D-5L scale
Self-reported health-related quality of life is measured with EQ-5D at baseline and discharge. Items are scored level 1-5 (1 = no problems, 5 = unable/extreme problems). The visual analog scale is scored 0-100 (0 = worse imaginable health ever, 100 = best imaginable health ever). The scale generates a descriptive set that is compared to value sets to produce a value index.
Measured: Date of randomization to hospital discharge (assessed up to 6-weeks)
Secondary outcomes (8)
Change in health-related quality of life: EQ-5D-5L scale
Self-reported health-related quality of life is measured with EQ-5D at 30-days post-hospitalization. Items are scored level 1-5 (1 = no problems, 5 = unable/extreme problems). The visual analog scale is scored 0-100 (0 = worse imaginable health ever, 100 = best imaginable health ever). The scale generates a descriptive set that is compared to value sets to produce a value index.
Measured: From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks)
Change in Hospital-Acquired disability
Hospital-acquired disability will be measured using the Older Americans Resources and Services (OARS) Activities of Daily Living (ADL) Scale. ADLs will be assessed at baseline and discharge. Each item is scored 1-3 (1 = without help, 3 = completely unable to), yielding a total score of 0-7.
Measured: Date of randomization to hospital discharge (assessed up to 6-weeks)
Hospital-acquired disability
Hospital-acquired disability will be measured using the Older Americans Resources and Services (OARS) Activities of Daily Living (ADL) Scale. ADLs will be assessed at 30-days post-hospitalization. Each item is scored 1-3 (1 = without help, 3 = completely unable to), yielding a total score of 0-7.
Measured: From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks)
Number of participants with all-cause death, delirium, fall, infection, pressure ulcer
Composite endpoint
Measured: Date of randomization until date of first documented progression of all-cause death, delirium, fall, infection, pressure ulcer assessed up to hospital discharge (assessed up to 6-weeks)
Number of participants with all-cause death, discharge to healthcare facility, unplanned repeat hospital visit
Composite endpoint
Measured: Date of hospital discharge (assessed up to 6-weeks) until date of first documented progression of all-cause death, discharge to healthcare facility, unplanned repeat hospital visit assessed up to 30-days from hospital discharge
Length of stay
Number of days from cardiovascular unit admission to hospital discharge.
Measured: Date of cardiovascular unit admission to hospital discharge (assessed up to 6-weeks)
Time out of bed
Average number of hours per day out of bed recorded by actigraphy
Measured: Date of randomization to hospital discharge (assessed up to 6-weeks)
Lower extremity physical performance
Lower extremity weakness will be assessed using the Short Physical Performance Battery scale (SPPB) at baseline and discharge. SPPB is scored 0-12 (0 = worst physical performance, 12 = best physical performance).
Measured: Date of randomization to hospital discharge (assessed up to 6-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start5 Mar 2020
- Primary completion24 Sep 2021
- Study completion24 Sep 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center randomized clinical trial with parallel group design at the Jewish General Hospital (JGH); an academic tertiary care center in Montreal, Quebec, Canada.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Afilalo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan Afilalo, Jewish General Hospital
- Investigators
- Jonathan Afilalo, MD, MSc, Principal investigator, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291690
- Sponsor's protocol ID
- TARGET-EFT 2020-2077
- Acronym
- TARGET-EFT
- Status last verified
- Mar 2022
- First submitted
- 9 Jan 2020
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fountotos R, Ahmad F, Bharaj N, Munir H, Marsala J, Rudski LG, Goldfarb M, Afilalo J. Multicomponent intervention for frail and pre-frail older adults with acute cardiovascular conditions: The TARGET-EFT randomized clinical trial. J Am Geriatr Soc. 2023 May;71(5):1406-1415. doi: 10.1111/jgs.18228. Epub 2023 Jan 16.
PubMed 36645227
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TARGET-EFT Trial (MulTicomponent Acute Intervention in FRail GEriatric PaTients With Cardiovascular Disease Using the Essential Frailty Toolset)
- ClinicalTrials.gov ID
- NCT04291690
- Acronym / sponsor ID
- TARGET-EFT / TARGET-EFT 2020-2077
- Keywords
- Randomized Clinical Trial, Frailty, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Jonathan AfilaloUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 24 Sep 2021 (actual)
- Study completion
- 24 Sep 2021 (actual)
- First posted
- 2 Mar 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.
Randomized clinical trial to determine whether a multicomponent intervention will lead to improvements in mobility, self-care, mood, pain, and physical activity among frail and pre-frail older adults (as measured with the Essential Frailty Toolset; EFT) hospitalized for an acute cardiovascular illness.
Detailed description
The investigators will conduct a single-center randomized clinical trial at the Jewish General Hospital; an academic tertiary care center in Montreal, Quebec. Researchers will pre-screen stable patients ≥65 years of age admitted to the cardiovascular unit. The investigators will target those that consent and have evidence of frailty or pre-frailty according to the EFT (score ≥1/5). The EFT consists of a chair rise test to screen for physical frailty, a mini-cog test to screen for cognitive impairment, a hemoglobin level and a serum albumin level. Patients will be randomly allocated to the usual-care control group, or the intervention group that will receive targeted treatments depending on the EFT deficits identified. All patients will be outfitted with a hip-worn accelerometer to monitor position, step count, and sleep data during the study period. Patients will undergo a structured questionnaire and physical performance assessment at baseline (upon index admission) and at discharge, and will be contacted by telephone 30 days post-discharge to assess their recovery. The primary endpoint will be represented by the EQ-5D scale (mobility, self-care, mood, pain, and physical activity) measured by blinded observers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-center randomized clinical trial with parallel group design at the Jewish General Hospital (JGH); an academic tertiary care center in Montreal, Quebec, Canada.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Usual clinical care as prescribed by their treating clinicians; which may or may not include physiotherapy, geriatric consultation, nutritional consultation and supplementation, and treatment of anemia. |
| Intervention Group | Experimental | Other: Physical Component of the Intervention, Other: Cognitive Component of the Intervention, Other: Nutritional Component of the Intervention, Other: Iron-Deficiency Anemia (IDA) Component of the InterventionMulti-component intervention in addition to usual care; which may include - in a targeted fashion - physical training for those with physical weakness, cognitive stimulation for those with cognitive impairment, oral nutritional supplementation for those with malnutrition, and intravenous iron replacement therapy for those with iron deficiency anemia. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥65 years
- Frail or pre-frail as defined by EFT score ≥1
- Admission to the JGH cardiovascular unit
- Signed informed consent
Key exclusion criteria (11 listed)
- Expected discharge within <3 days
- Clinically unstable (unstable vital signs, low-threshold coronary ischemia, uncontrolled heart failure, uncontrolled arrhythmia)
- Awaiting cardiac surgery during the index hospitalization
- Severe dementia (MMSE ≤10/30)
- Delirium (CAM positive)
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 |
|---|---|---|
| Physical Component of the InterventionWe will encourage and assist patients to walk around the ward as tolerated and approved by their treating clinicians, to maximize the time spent out of bed, minimize the time spent in bed, and to encourage and assist them to perform chair rises to build lower extremity strength. For selected intervention patients with greater physical weakness, defined as SPPB ≤9, a Certified Exercise Physiologist will administer a supervised multicomponent exercise program combining strength, flexibility, balance and gait for the prevention of weakness and falls. The exercise program is adapted from the Vivifrail program which is an EU-funded initiative that provides a guide to prevent frailty, physical deconditioning, and incident disability in older persons. The program includes two daily sessions, one in the morning and one in the afternoon, for a duration of 20 minutes each. The morning session includes strength and flexibility exercises. The afternoon session targets balance and walking. | Other | Intervention Group |
| Cognitive Component of the InterventionWe will encourage and assist them to wear their hearing and visual aids (if they have these), orient them to time and place verbally and in writing on a clearly visible white-board in their hospital room - and also encourage their family members and caregivers to do so on a regular basis, and inquire about their sleep quality and communicate with the clinical team to reduce sleep disturbances. For selected intervention patients with greater cognitive impairments, defined as MMSE ≤26, we will provide cognitive simulation twice daily during the scheduled visits. Cognitive stimulation comprises of activities with the patient, including but not limited to current news, trivia, crossword puzzles, and memory games. These cognitive interventions are adapted from the Hospital Elder Life Program (HELP) that targets risk factors for delirium. | Other | Intervention Group |
| Nutritional Component of the InterventionWe will reinforce proper eating habits, encourage and assist patients to wear their dentures (if they have these), and inquire about their food preferences and eating barriers and communicate with the clinical dieticians to address these issues. For selected intervention patients with greater nutritional deficits, defined as a positive PONS, we will recommend to the treating clinicians to prescribe MedPass supplementation. PONS, developed as a preoperative screening tool but also used in nonoperative medical settings, reflects low body mass index, weight loss, low dietary intake, and albumin level. MedPass is a 60 mL calorically dense (2 kcal/mL) oral nutritional supplement consumed between meals 4 times per daily. If MedPass supplementation is contraindicated, the treating team will have the full discretion not to prescribe it and/or to consider alternative supplementation strategies. | Other | Intervention Group |
| Iron-Deficiency Anemia (IDA) Component of the InterventionWe will verify their clinical blood test results for hemoglobin level and iron studies and apply the diagnostic criteria for iron deficiency as recommended by the Canadian Cardiovascular Society Guidelines for Heart Failure. These criteria are: (i) Hemoglobin <130g/L in men or <120g/L in women with (ii) a Ferritin <100μg/L or a Ferritin <300μg/L with a Saturation <20%. For selected intervention patients with diagnosed iron deficiency anemia, according to these established criteria, we will recommend to the treating clinicians to prescribe Venofer intravenous iron replacement therapy. The use of intravenous iron replacement therapy is a Strong Recommendation in the Canadian Cardiovascular Society Guidelines. Venofer is prescribed at a dosage of 300 mg IV daily for a total of 3 doses. If Venofer supplementation is contraindicated, the treating team will have the full discretion not to prescribe it and/or to consider alternative strategies. | Other | Intervention Group |
Primary outcome
Change in health-related quality of life: EQ-5D-5L scale
Time frame: Date of randomization to hospital discharge (assessed up to 6-weeks)
Self-reported health-related quality of life is measured with EQ-5D at baseline and discharge. Items are scored level 1-5 (1 = no problems, 5 = unable/extreme problems). The visual analog scale is scored 0-100 (0 = worse imaginable health ever, 100 = best imaginable health ever). The scale generates a descriptive set that is compared to value sets to produce a value index.
8 secondary outcomes
Change in health-related quality of life: EQ-5D-5L scale
Time frame: From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks)
Change in Hospital-Acquired disability
Time frame: Date of randomization to hospital discharge (assessed up to 6-weeks)
Hospital-acquired disability
Time frame: From date of hospital discharge (assessed up to 6-weeks) to 30-days post-discharge (assessed up to 10 weeks)
Number of participants with all-cause death, delirium, fall, infection, pressure ulcer
Time frame: Date of randomization until date of first documented progression of all-cause death, delirium, fall, infection, pressure ulcer assessed up to hospital discharge (assessed up to 6-weeks)
Number of participants with all-cause death, discharge to healthcare facility, unplanned repeat hospital visit
Time frame: Date of hospital discharge (assessed up to 6-weeks) until date of first documented progression of all-cause death, discharge to healthcare facility, unplanned repeat hospital visit assessed up to 30-days from hospital discharge
Length of stay
Time frame: Date of cardiovascular unit admission to hospital discharge (assessed up to 6-weeks)
Time out of bed
Time frame: Date of randomization to hospital discharge (assessed up to 6-weeks)
Lower extremity physical performance
Time frame: Date of randomization to hospital discharge (assessed up to 6-weeks)
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 31 Mar 2022.
- Derived from this study: PubMed 36645227Fountotos R, Ahmad F, Bharaj N, Munir H, Marsala J, Rudski LG, Goldfarb M, Afilalo J. Multicomponent intervention for frail and pre-frail older adults with acute cardiovascular conditions: The TARGET-EFT randomized clinical trial. J Am Geriatr Soc. 2023 May;71(5):1406-1415. doi: 10.1111/jgs.18228. Epub 2023 Jan 16.
Related trials for Frailty
Not yet recruiting
PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty
Frailty, Sarcopenia
Recruiting
The VICTORY Trial: Virtual, Innovative, Postsurgical Care To Optimize Return Home for Older People With frailtY
Surgery, Frailty
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Recruiting
Frailty Training for Emergency Nurses: A Cluster RCT in Morocco
Frail Elderly, Frailty
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.
Jonathan Afilalo, MD, MSc principal investigator
Jewish General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Component of the Intervention, Cognitive Component of the Intervention and Nutritional Component of the Intervention in people with Frailty and Cardiovascular Diseases in Old Age, run by Jonathan Afilalo 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 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 31 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 health-related quality of life: EQ-5D-5L scale (time frame: Date of randomization to hospital discharge (assessed up to 6-weeks)). 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 NCT04291690, 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 31 Mar 2022.