Acute Respiratory Failurem-CCRPNCT03053245
Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors
A study testing Mobile Critical Care Program in people with Acute Respiratory Failure and Post-Intensive Care Syndrome, run by Indiana University at 3 sites in United States.
Trial summary
The m-CCRP randomized controlled trial will evaluate the efficacy of a collaborative critical care recovery program from acute respiratory failure (ARF) survivors in accomplishing the Institute of Healthcare Improvement's triple aims of better health, better care, at lower cost. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure, Post-Intensive Care Syndrome
- What is being tested?
- Mobile Critical Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 503 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2017to 31 Oct 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Hospitalized in the ICU
- Diagnosed with Acute Respiratory Failure (ARF) requiring greater than or equal to 24 hours of mechanical ventilation or noninvasive positive pressure ventilation or high flow nasal canula.
- Discharged to home, skilled nursing facility, sub-acute rehabilitation care, or long-term acute care
- English speaking
- Able to consent either in-person or through legally authorized representative
- Have access to a telephone
Who cannot join
- Hospitalized to a regular non-ICU ward
- Diagnosis of cancer with life expectancy less than 1 year
- Admitted with ischemic or hemorrhagic cerebrovascular accident, traumatic brain injury, or undergoing neurosurgery
- History of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease, Parkinson's disease, or vascular dementia
- Unable to complete study questionnaire due to severe hearing loss
- Legally blind
Show all 14Show fewer
- Pregnant (assessed by urine pregnancy test) or nursing
- Living outside the greater Indianapolis area
- Recent history of alcohol or substance abuse
- Status post tracheostomy and not eligible for a speaking valve
- Incarcerated at the time of study enrollment
- Schizophrenia or bipolar disorder (confirmed by EMR)
- Homelessness
- Illiterate
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Eskenazi Hospital
Indianapolis, Indiana, 46202
Methodist Hospital
Indianapolis, Indiana, 46202
University Hospital
Indianapolis, Indiana, 46202
About this study
The m-CCRP randomized controlled trial will evaluate the efficacy of a collaborative critical care recovery program from acute respiratory failure (ARF) survivors in accomplishing the Institute of Healthcare Improvement's triple aims of better health, better care, at lower cost.
Primary Aim:
Read more
To assess the efficacy of m-CCRP in improving the QOL of ARF survivors compared to attention control at twelve months post hospital discharge.
Secondary Aims:
- To evaluate the efficacy of m-CCRP in improving cognitive, physical, and psychological function of ARF survivors at twelve months post hospital discharge when compared to attention control.
- To evaluate the efficacy of m-CCRP in reducing health-care utilization, defined as time from enrollment to emergency department visits and/or hospital re-admission, by ARF survivors as compared to attention control at twelve months post hospital discharge.
Read the detailed description
Five million Americans require admission to intensive care units (ICU) annually due to life threatening illnesses, and this number is expected to rise.4 Two million of these ICU admissions are secondary to Acute Respiratory Failure (ARF) with more than half requiring mechanical ventilation. Greater than 50% of the patients with ARF who survive their ICU stay suffer from long-term morbidity in the form of functional disability, cognitive disability, major or minor depression, and anxiety. These complications negatively impact the quality of life (QOL) of ARF survivors, interfere with their physical and emotional recovery, and lead to long-term disability with less than half of ARF survivors returning to the work force. Ongoing care for ARF survivors has been estimated to cost $3.5 million per ARF survivor at 1 year. This constellation of ICU sequelae with attendant morbidity has been designated as the post-intensive care syndrome (PICS). There are community resources and rehabilitation services available to ARF survivors, but the current fragmented nature of our healthcare system is unable to integrate and coordinate care in order to provide the most meaningful recovery.
The Institute of Medicine recommends the development of care coordination programs to deliver patient-centered and interdisciplinary-based medical care. Indiana University Center for Aging Research (IUCAR) has over 20 years of experience in delivering interdisciplinary, collaborative care through pragmatic interventions utilizing care coordinators. Care coordinator delivery models have improved care of patients with dementia, depression, functional decline and PICS. Our PICS clinic, the Critical Care Recovery Center (CCRC) was developed in 2011 to enhance cognitive, physical, and psychological recovery of ICU survivors.
Since then, CCRC has provided care to over 200 survivors with a high burden of PICS (88% had cognitive impairment; 60% had depression). CCRC showed feasibility and initial efficacy in managing PICS. However given its traditional outpatient clinic structure, CCRC has limited physical access to ARF survivors, leading to delayed evaluation and an added travel burden on ARF survivors. Building from the experience of the CCRC and our other successful care coordinator based programs; we now propose a mobile model of post-ICU collaborative care with greater access to enhance the recovery of ARF survivors.
The overarching aim of the proposed program is to improve the QOL of patients who survived an episode of ARF by maximizing their cognitive, physical, and psychological recovery utilizing a mobile care coordinator. The care coordinator will bring the intervention to the patient irrespective of the patient's physical location and will be supported by an interdisciplinary team of a critical care physician, a health services scientist, an ICU nurse, and a psychologist, with input from other consultants as needed. In addition, dynamic feedback through process measurement tools and care coordination support software will inform the recovery process. We propose to evaluate the efficacy of our collaborative care intervention termed the "Mobile Critical Care Recovery Program (m-CCRP)" through a randomized clinical trial among survivors of ARF.
- Being tested
- Mobile Critical Care Program, Attention Control
- Keywords
- Collaborative Care Model, Intensive Care Unit
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Critical Care ProgramBehavioural
The m-CCRP revolves around the central figure of a care coordinator who will organize and align recovery resources. The care coordinator is a registered nurse whose scope of practice includes health coaching, case managing, community organizing, and nursing care provider. The m-CCRP support team will consist of a critical care physician (Dr. Khan), a geriatrician with expertise in collaborative care (Dr. Boustani), an ICU collaborative care nurse (Dr. Lasiter), and a psychologist (Dr. Unverzagt). This team will meet weekly with the care coordinator. Drs. Khan and Boustani will be accessible to the coordinator through phone or pager at all times.
Attention ControlBehavioural
Patients in this group will receive regular wellness calls from the research team.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Critical Care Recovery Program | Experimental | The group will receive the Mobile Critical Care Recovery Program (m-CCRP) intervention which includes care coordination and collaborative care model for one year post enrollment. Receives: Behavioral: Mobile Critical Care Program |
| Attention Control | Active comparator | The attention control group will receive telephone based check ins related to their health from the research study team. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Reported Quality of Life PCS: Physical Component Score at 1 Year
Utilizing SF-36 The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) consists of eight domains. It yields two summary scores (PCS: physical component score, and MCS: mental component score). MCS and PCS range from 0 to 100, and higher scores indicate better health status. A difference of 2 or more points is considered clinically meaningful for both the PCS and MCS subscales of SF-36.
Measured: 1 year
Self Reported Quality of Life MCS: Mental Component Score at 1 Year
Utilizing SF-36 The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) consists of eight domains. It yields two summary scores (PCS: physical component score, and MCS: mental component score). MCS and PCS range from 0 to 100, and higher scores indicate better health status. A difference of 2 or more points is considered clinically meaningful for both the PCS and MCS subscales of SF-36.
Measured: 1 year
Cognitive Assessment Score at 1 Year
Utilizing RBANS: Repeatable Battery for the Assessment of Neuropsychological Status.
The overall RBANS z-score is the mean of the 7-item (RBANS subscale) z-scores that could be collected in person and by phone. The 7 subscales are: List Learning, Story Memory, Semantic fluency, Digit Span, List Recall, List Recognition, Story Recall.
A Z-Score of 0 is the population mean. Values above 0 represent better outcomes.
Measured: 1 year
Secondary outcomes (3)
Depression Symptoms at 1 Year
PHQ-9 (Patient Health Questionnaire-9) Scores range from 0 to 27 on the PHQ-9 with higher scores indicating greater severity of depression.
Measured: 1 year
Anxiety Symptoms at 1 Year
GAD-7 (Generalized Anxiety Disorder-7) Scores range from 0 to 21 on the GAD-7 with higher scores greater anxiety.
Measured: 1 year
Physical Performance at 1 Year
Utilizing SPPB The Short Physical Performance Battery (SPPB) will measure physical training effects on balance and strength.
Ranges from 0-12: higher score is better outcome
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start1 Mar 2017
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 503 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Babar Khan, MD, MS, Indiana University
- Investigators
- Babar A Khan, MD, MS, Principal investigator, Indiana University Center for Aging Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053245
- Sponsor's protocol ID
- R01HL131730
- Acronym
- m-CCRP
- Status last verified
- Jun 2024
- First submitted
- 1 Feb 2017
- Last updated
- 24 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Publications
Ferguson H, Sanjuan A, Perkins AJ, Elias M, Wang S, Mekala SN, Devine B, Koehler Z, Chi R, Gao S, Khan B, Khan S. Relationship Between ICU Delirium and Change in Quality of Life, Mood, and Cognition Over 12 Months in Survivors of Acute Respiratory Failure. CHEST Crit Care. 2026 Mar;4(1):100242. doi: 10.1016/j.chstcc.2026.100242. Epub 2026 Feb 26.
PubMed 41938652Savsani PK, Khan SH, Perkins AJ, Wang S, Jawaid S, Moiz S, Monahan PO, Kroenke K, Gao S, Khan BA. Performance of the Healthy Aging Brain Care Monitor Self Report in Monitoring Post-Intensive Care Syndrome Among Acute Respiratory Failure Survivors. Crit Care Med. 2025 Feb 1;53(2):e341-e352. doi: 10.1097/CCM.0000000000006522. Epub 2024 Nov 11.
PubMed 39526840Khan BA, Perkins AJ, Khan SH, Unverzagt FW, Lasiter S, Gao S, Wang S, Zarzaur BL, Rahman O, Eltarras A, Qureshi H, Boustani MA. Mobile Critical Care Recovery Program for Survivors of Acute Respiratory Failure: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2353158. doi: 10.1001/jamanetworkopen.2023.53158.
PubMed 38289602Khan S, Biju A, Wang S, Gao S, Irfan O, Harrawood A, Martinez S, Brewer E, Perkins A, Unverzagt FW, Lasiter S, Zarzaur B, Rahman O, Boustani M, Khan B. Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial. Trials. 2018 Feb 7;19(1):94. doi: 10.1186/s13063-018-2449-2.
PubMed 29415760
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Critical Care Recovery Program for Acute Respiratory Failure Survivors
- ClinicalTrials.gov ID
- NCT03053245
- Acronym / sponsor ID
- m-CCRP / R01HL131730
- Keywords
- Collaborative Care Model, Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 503 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Posted 24 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The m-CCRP randomized controlled trial will evaluate the efficacy of a collaborative critical care recovery program from acute respiratory failure (ARF) survivors in accomplishing the Institute of Healthcare Improvement's triple aims of better health, better care, at lower cost.
Primary Aim:
To assess the efficacy of m-CCRP in improving the QOL of ARF survivors compared to attention control at twelve months post hospital discharge.
Secondary Aims:
- To evaluate the efficacy of m-CCRP in improving cognitive, physical, and psychological function of ARF survivors at twelve months post hospital discharge when compared to attention control.
- To evaluate the efficacy of m-CCRP in reducing health-care utilization, defined as time from enrollment to emergency department visits and/or hospital re-admission, by ARF survivors as compared to attention control at twelve months post hospital discharge.
Detailed description
Five million Americans require admission to intensive care units (ICU) annually due to life threatening illnesses, and this number is expected to rise.4 Two million of these ICU admissions are secondary to Acute Respiratory Failure (ARF) with more than half requiring mechanical ventilation. Greater than 50% of the patients with ARF who survive their ICU stay suffer from long-term morbidity in the form of functional disability, cognitive disability, major or minor depression, and anxiety. These complications negatively impact the quality of life (QOL) of ARF survivors, interfere with their physical and emotional recovery, and lead to long-term disability with less than half of ARF survivors returning to the work force. Ongoing care for ARF survivors has been estimated to cost $3.5 million per ARF survivor at 1 year. This constellation of ICU sequelae with attendant morbidity has been designated as the post-intensive care syndrome (PICS). There are community resources and rehabilitation services available to ARF survivors, but the current fragmented nature of our healthcare system is unable to integrate and coordinate care in order to provide the most meaningful recovery.
The Institute of Medicine recommends the development of care coordination programs to deliver patient-centered and interdisciplinary-based medical care. Indiana University Center for Aging Research (IUCAR) has over 20 years of experience in delivering interdisciplinary, collaborative care through pragmatic interventions utilizing care coordinators. Care coordinator delivery models have improved care of patients with dementia, depression, functional decline and PICS. Our PICS clinic, the Critical Care Recovery Center (CCRC) was developed in 2011 to enhance cognitive, physical, and psychological recovery of ICU survivors.
Since then, CCRC has provided care to over 200 survivors with a high burden of PICS (88% had cognitive impairment; 60% had depression). CCRC showed feasibility and initial efficacy in managing PICS. However given its traditional outpatient clinic structure, CCRC has limited physical access to ARF survivors, leading to delayed evaluation and an added travel burden on ARF survivors. Building from the experience of the CCRC and our other successful care coordinator based programs; we now propose a mobile model of post-ICU collaborative care with greater access to enhance the recovery of ARF survivors.
The overarching aim of the proposed program is to improve the QOL of patients who survived an episode of ARF by maximizing their cognitive, physical, and psychological recovery utilizing a mobile care coordinator. The care coordinator will bring the intervention to the patient irrespective of the patient's physical location and will be supported by an interdisciplinary team of a critical care physician, a health services scientist, an ICU nurse, and a psychologist, with input from other consultants as needed. In addition, dynamic feedback through process measurement tools and care coordination support software will inform the recovery process. We propose to evaluate the efficacy of our collaborative care intervention termed the "Mobile Critical Care Recovery Program (m-CCRP)" through a randomized clinical trial among survivors of ARF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Critical Care Recovery Program | Experimental | Behavioral: Mobile Critical Care ProgramThe group will receive the Mobile Critical Care Recovery Program (m-CCRP) intervention which includes care coordination and collaborative care model for one year post enrollment. |
| Attention Control | Active comparator | Behavioral: Attention ControlThe attention control group will receive telephone based check ins related to their health from the research study team. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age
- Hospitalized in the ICU
- Diagnosed with Acute Respiratory Failure (ARF) requiring greater than or equal to 24 hours of mechanical ventilation or noninvasive positive pressure ventilation or high flow nasal canula.
- Discharged to home, skilled nursing facility, sub-acute rehabilitation care, or long-term acute care
- English speaking
Key exclusion criteria (14 listed)
- Hospitalized to a regular non-ICU ward
- Diagnosis of cancer with life expectancy less than 1 year
- Admitted with ischemic or hemorrhagic cerebrovascular accident, traumatic brain injury, or undergoing neurosurgery
- History of dementing illnesses and other neurodegenerative disease such as Alzheimer's disease, Parkinson's disease, or vascular dementia
- Unable to complete study questionnaire due to severe hearing loss
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 |
|---|---|---|
| Mobile Critical Care ProgramThe m-CCRP revolves around the central figure of a care coordinator who will organize and align recovery resources. The care coordinator is a registered nurse whose scope of practice includes health coaching, case managing, community organizing, and nursing care provider. The m-CCRP support team will consist of a critical care physician (Dr. Khan), a geriatrician with expertise in collaborative care (Dr. Boustani), an ICU collaborative care nurse (Dr. Lasiter), and a psychologist (Dr. Unverzagt). This team will meet weekly with the care coordinator. Drs. Khan and Boustani will be accessible to the coordinator through phone or pager at all times. | Behavioural | Mobile Critical Care Recovery Program |
| Attention ControlPatients in this group will receive regular wellness calls from the research team. | Behavioural | Attention Control |
Primary outcome
Self Reported Quality of Life PCS: Physical Component Score at 1 Year
Time frame: 1 year
Utilizing SF-36 The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) consists of eight domains. It yields two summary scores (PCS: physical component score, and MCS: mental component score). MCS and PCS range from 0 to 100, and higher scores indicate better health status. A difference of 2 or more points is considered clinically meaningful for both the PCS and MCS subscales of SF-36.
Self Reported Quality of Life MCS: Mental Component Score at 1 Year
Time frame: 1 year
Utilizing SF-36 The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) consists of eight domains. It yields two summary scores (PCS: physical component score, and MCS: mental component score). MCS and PCS range from 0 to 100, and higher scores indicate better health status. A difference of 2 or more points is considered clinically meaningful for both the PCS and MCS subscales of SF-36.
Cognitive Assessment Score at 1 Year
Time frame: 1 year
Utilizing RBANS: Repeatable Battery for the Assessment of Neuropsychological Status. The overall RBANS z-score is the mean of the 7-item (RBANS subscale) z-scores that could be collected in person and by phone. The 7 subscales are: List Learning, Story Memory, Semantic fluency, Digit Span, List Recall, List Recognition, Story Recall. A Z-Score of 0 is the population mean. Values above 0 represent better outcomes.
3 secondary outcomes
Depression Symptoms at 1 Year
Time frame: 1 year
Anxiety Symptoms at 1 Year
Time frame: 1 year
Physical Performance at 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41938652Ferguson H, Sanjuan A, Perkins AJ, Elias M, Wang S, Mekala SN, Devine B, Koehler Z, Chi R, Gao S, Khan B, Khan S. Relationship Between ICU Delirium and Change in Quality of Life, Mood, and Cognition Over 12 Months in Survivors of Acute Respiratory Failure. CHEST Crit Care. 2026 Mar;4(1):100242. doi: 10.1016/j.chstcc.2026.100242. Epub 2026 Feb 26.
- Derived from this study: PubMed 39526840Savsani PK, Khan SH, Perkins AJ, Wang S, Jawaid S, Moiz S, Monahan PO, Kroenke K, Gao S, Khan BA. Performance of the Healthy Aging Brain Care Monitor Self Report in Monitoring Post-Intensive Care Syndrome Among Acute Respiratory Failure Survivors. Crit Care Med. 2025 Feb 1;53(2):e341-e352. doi: 10.1097/CCM.0000000000006522. Epub 2024 Nov 11.
- Derived from this study: PubMed 38289602Khan BA, Perkins AJ, Khan SH, Unverzagt FW, Lasiter S, Gao S, Wang S, Zarzaur BL, Rahman O, Eltarras A, Qureshi H, Boustani MA. Mobile Critical Care Recovery Program for Survivors of Acute Respiratory Failure: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2353158. doi: 10.1001/jamanetworkopen.2023.53158.
- Derived from this study: PubMed 29415760Khan S, Biju A, Wang S, Gao S, Irfan O, Harrawood A, Martinez S, Brewer E, Perkins A, Unverzagt FW, Lasiter S, Zarzaur B, Rahman O, Boustani M, Khan B. Mobile critical care recovery program (m-CCRP) for acute respiratory failure survivors: study protocol for a randomized controlled trial. Trials. 2018 Feb 7;19(1):94. doi: 10.1186/s13063-018-2449-2.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
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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.
Babar A Khan, MD, MS principal investigator
Indiana University Center for Aging Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Critical Care Program in people with Acute Respiratory Failure and Post-Intensive Care Syndrome, run by Indiana University at 3 sites 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 7 inclusion and 14 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 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 24 Jun 2024). 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?
Self Reported Quality of Life PCS: Physical Component Score at 1 Year (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT03053245, which also lists 4 linked publications.
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 24 Jun 2024.