FamilyICU-CARENCT05157919
Mobile App to Promote Family Caregiver Engagement in the Intensive Care Unit
A study testing ICU-Care in people with Family and Critical Care, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this randomized controlled pilot trial is to develop and test mobile app, Intensive Care Unit-Caregiver Activation Response, and Engagement (ICU-CARE). ICU-CARE provides a simulated learning environment to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Family, Critical Care, Mobile Applications
- What is being tested?
- ICU-Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 1 Jun 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Caregivers of mechanically ventilated ICU patients who are:
- Age 19 or older
- Able to understand English
- Able and willing to use the hospital-provided tablet devices
- Can view images on a screen and hear audio through a standard headset
- Have basic reading skills and the ability to read aloud
Show all 14Show fewer
- Critically ill patients in the ICU who are:
- Age 19 or older
- Mechanically ventilated
- Expected to require> 72 consecutive hours of mechanical ventilation during their ICU stay
- Calm, cooperative (a Richmond Agitation-Sedation Scale score between -5 and +1)
- Able to reliably report symptoms of thirst and anxiety per nursing assessment
- Have no documented hearing deficits
- Have a designated caregiver who visits frequently (daily for a minimum of 1 hour)
Who cannot join
- Adult Caregivers of mechanically ventilated ICU patients who are:
- Caregivers of patients who are not currently undergoing mechanical ventilation
- Caregivers of patients who are not calm, cooperative (a Richmond Agitation- - Sedation Scale score between +2 and +4),
- Caregivers of patients who cannot reliably report symptoms of thirst and anxiety
- Caregivers of patients who have a documented hearing deficit.
- Caregivers who do not visit the patient frequently (at least once per day for a minimum of 1 hour as described by nursing staff)
Show all 12Show fewer
- Critically ill patients in the ICU who are:
- Recovering from any of the following surgeries: Glossectomy, Maxillectomy, Neck Dissection, Facial/neck flap
- Receiving aggressive ventilator support such as positive end expiratory pressure> 15cm of water, prone ventilation
- Not alert per nursing assessment (Richmond Agitation-Sedation Scale Score +2 or greater)
- Severe cognition or communication problems (i.e. coma as the main reason for intubation, dementia, severe delirium)
- Deafness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Mobile App to Promote Family Caregiver Engagement in Symptom Assessment and Management During Mechanical Ventilation in the Intensive Care Unit
The purpose of this randomized controlled pilot trial is to develop and test mobile app, Intensive Care Unit-Caregiver Activation Response, and Engagement (ICU-CARE). ICU-CARE provides a simulated learning environment to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic comfort measures to help alleviate patient symptom burden.
Read the detailed description
Critical care guidelines call for the liberal inclusion of family caregivers into bedside care, but despite convincing evidence that active family participation improves the patient and family experience as well as safety, quality, and delivery of care, critical care nurses have few evidence-based strategies to engage family caregivers as active participants in the provision of care in the intensive care unit (ICU). The broad objective of this proposal is to develop and test a mobile app, Intensive Care Unit-Caregiver Activation Response and Engagement [ICU-CARE]. ICU-CARE provides a simulated learning environment that incorporates established motivational learning theories to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic symptom management techniques to help alleviate the patient's symptom burden. This project, guided by the Individual and Family Self-Management Theory, aims to (1) Establish the feasibility and acceptability of the ICU-CARE intervention for family caregivers enrolled in the experimental arm; and (2) Determine the influence of the ICU-CARE intervention on the caregiver process characteristics, proximal caregiving outcomes, and distal caregiving outcomes as compared to family caregivers enrolled in the control arm. To address these study aims, a convenience sample of 60 family caregivers of mechanically ventilated patients will be recruited into this randomized controlled pilot trial. 30 participants will be enrolled to the control group which will receive usual care with routine caregiver support practices. Intervention participants (n=30) will be enrolled to an experimental condition ICU-CARE, that will consist of a theoretically grounded mobile app program to promote caregiver engagement in symptom assessment and management in the ICU. This project will help further define the scope, extent, and nature of patient and family engagement in the ICU, and if proven feasible, our intervention holds the potential to shift the ICU nursing practice paradigm by integrating family caregivers as dynamic partners in ICU care.
- Conditions
- Family, Critical Care, Mobile Applications
- Being tested
- ICU-Care
- Keywords
- Caregiver, Critical Illness, Family, Psychological Distress, Family-Centered Nursing
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU-CareBehavioural
The mobile app intervention, ICU-CARE, will consist of 3 separate education modules, each approximately 5-7 minutes in length: (Module #1) ICU orientation, (Module #2) Symptom Assessment, (Module #3) Symptom Management
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Usual care continues. The caregiver will not get to use the app. The caregiver will be asked daily measures and the patient will be asked about thirst and anxiety daily when the patient is awake enough to answer these questions. The caregiver will be asked questions at 3 different times: Day 1, 24-48 hours after enrollment, and 2-4 weeks after the patient is discharged from the ICU. |
| Intervention with App | Experimental | The caregiver gets access to use the app. Each day, investigators will ask the patient to rate their thirst and anxiety and the caregiver to answer daily measures through the application. The caregiver will be asked questions at 3 different times: Day 1, 24-48 hours after enrollment, and 2-4 weeks after the patient is discharged from the ICU. The caregiver will be taught how to use the app. The caregiver will be given the supplies that the caregiver needs to perform the symptom management intervention. Investigators will ask the caregiver to use the app at least once a day, but the caregiver can use it as much as desired while the patient is in the ICU. Receives: Behavioral: ICU-Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Feasibility of ICU-CARE
Total subjects screened, approached, consented and refused
Measured: Through study completion, estimated 3 years.
Sustainability of ICU-CARE enrollment
Differential attrition rates - the number of subjects in each group that complete all study follow-up measures
Measured: Through study completion, estimated 3 years.
Dosage of ICU-CARE
Number of doses of the intervention per participant
Measured: Through study completion, estimated 3 years.
Acceptability of ICU-CARE
Total score of a modified version of the Educational Material Acceptability Instrument. Minimum Score = 11; Maximum Score = 55. Higher score indicates greater acceptance.
Measured: Through study completion, estimated 3 years.
Secondary outcomes (16)
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Activation
Caregiver activation as measured by Patient Activation Measure for Family Caregivers (CG-PAM). Minimum score = 1; Maximum Score = 4. Higher score indicates greater activation.
Measured: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Self-efficacy
Caregiver self-efficacy as measured by the Caregiver Self-Efficacy Scale (CaSES). Scale contains four sub-scales that are scored separately. Minimum Score =1; Maximal Score = 5. Higher scores indicate greater self-efficacy.
Measured: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Preparedness
Caregiver Preparedness as measured by the Preparedness for Caregiving Scale (Prep Scale). Minimum score = 0; Maximum score = 32. The higher the score the more prepared the caregiver feels for caregiving.
Measured: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Assessment
Rate of symptom assessment behaviors - the number of times in a 24 hour period that the subject records a patient symptom assessment in the ICU-CARE app
Measured: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Management
Rate of symptom management behaviors - the number of times in a 24 hour period that the subject records a patient symptom management technique in the ICU-CARE app
Measured: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Caregiver Anxiety
Caregiver anxiety as measured by the State-Trait Anxiety Inventory (STAI-State). Minimum score = 0; Maximum score = 6. Higher scores indicate greater anxiety.
Measured: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Thirst
Patient thirst as measured by a 0-100 visual analogue scale for thirst (VAS-Thirst)
Measured: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Anxiety
Patient anxiety as measured by a 0-100 visual analogue scale for anxiety (VAS-Anxiety)
Measured: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Global Health Status
Caregiver Global Health Status as measured by the Patient-Reported Outcome Measure (PROMIS-10). 5 questions each on 2 (1-5) subscales (Global Physical Health, Global Mental Health). Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks. Higher scores indicate a healthier patient.
Measured: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Anxiety & Depressive Symptoms
Caregiver anxiety and depressive symptoms as measured by the Hospital Anxiety and Depression Scale (HADS). Two sub-scales (Anxiety \& Depression) scored separately. Minimum Score = 0; Maximum Score = 21. Higher score = higher anxiety and/or depression.
Measured: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Satisfaction
Caregiver satisfaction as measured by the Critical Care Family Satisfaction Survey (CCFSS). Minimum Score = 5; Maximum score = 25. Higher scores indicate greater satisfaction.
Measured: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver ICU Experience
Overall impact of ICU experience for caregivers as measured by the Impact of Events Scale-Revised. Minimum Score = 0; Maximum Score = 88. Higher score indicates great impact of life event.
Measured: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Agitation
Nurse documentation of patient agitation in the electronic health record
Measured: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Pain
Nurse documentation of patient pain in the electronic health record
Measured: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Duration of Ventilation
Duration of mechanical ventilation
Measured: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Sedative Exposure
Sedative exposure (sedation intensity and sedation frequency)
Measured: Through study completion, estimated 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start6 Jan 2020
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FamilyStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Breanna D Hetland, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157919
- Sponsor's protocol ID
- 0625-17-EP
- Acronym
- ICU-CARE
- Status last verified
- Jan 2024
- First submitted
- 16 Jul 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Mobile App to Promote Family Caregiver Engagement in Symptom Assessment and Management During Mechanical Ventilation in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05157919
- Acronym / sponsor ID
- ICU-CARE / 0625-17-EP
- Conditions
- Family, Critical Care, Mobile Applications
- Keywords
- Caregiver, Critical Illness, Family, Psychological Distress, Family-Centered Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 15 Dec 2021 (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 purpose of this randomized controlled pilot trial is to develop and test mobile app, Intensive Care Unit-Caregiver Activation Response, and Engagement (ICU-CARE). ICU-CARE provides a simulated learning environment to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic comfort measures to help alleviate patient symptom burden.
Detailed description
Critical care guidelines call for the liberal inclusion of family caregivers into bedside care, but despite convincing evidence that active family participation improves the patient and family experience as well as safety, quality, and delivery of care, critical care nurses have few evidence-based strategies to engage family caregivers as active participants in the provision of care in the intensive care unit (ICU). The broad objective of this proposal is to develop and test a mobile app, Intensive Care Unit-Caregiver Activation Response and Engagement [ICU-CARE]. ICU-CARE provides a simulated learning environment that incorporates established motivational learning theories to encourage family caregivers of mechanically ventilated patients to assess two patient symptoms, thirst and anxiety, and perform specific nonpharmacologic symptom management techniques to help alleviate the patient's symptom burden. This project, guided by the Individual and Family Self-Management Theory, aims to (1) Establish the feasibility and acceptability of the ICU-CARE intervention for family caregivers enrolled in the experimental arm; and (2) Determine the influence of the ICU-CARE intervention on the caregiver process characteristics, proximal caregiving outcomes, and distal caregiving outcomes as compared to family caregivers enrolled in the control arm. To address these study aims, a convenience sample of 60 family caregivers of mechanically ventilated patients will be recruited into this randomized controlled pilot trial. 30 participants will be enrolled to the control group which will receive usual care with routine caregiver support practices. Intervention participants (n=30) will be enrolled to an experimental condition ICU-CARE, that will consist of a theoretically grounded mobile app program to promote caregiver engagement in symptom assessment and management in the ICU. This project will help further define the scope, extent, and nature of patient and family engagement in the ICU, and if proven feasible, our intervention holds the potential to shift the ICU nursing practice paradigm by integrating family caregivers as dynamic partners in ICU care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Usual care continues. The caregiver will not get to use the app. The caregiver will be asked daily measures and the patient will be asked about thirst and anxiety daily when the patient is awake enough to answer these questions. The caregiver will be asked questions at 3 different times: Day 1, 24-48 hours after enrollment, and 2-4 weeks after the patient is discharged from the ICU. |
| Intervention with App | Experimental | Behavioral: ICU-CareThe caregiver gets access to use the app. Each day, investigators will ask the patient to rate their thirst and anxiety and the caregiver to answer daily measures through the application. The caregiver will be asked questions at 3 different times: Day 1, 24-48 hours after enrollment, and 2-4 weeks after the patient is discharged from the ICU. The caregiver will be taught how to use the app. The caregiver will be given the supplies that the caregiver needs to perform the symptom management intervention. Investigators will ask the caregiver to use the app at least once a day, but the caregiver can use it as much as desired while the patient is in the ICU. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 19 or older
- Able to understand English
- Able and willing to use the hospital-provided tablet devices
- Can view images on a screen and hear audio through a standard headset
- Have basic reading skills and the ability to read aloud
Key exclusion criteria (12 listed)
- Caregivers of patients who are not currently undergoing mechanical ventilation
- Caregivers of patients who are not calm, cooperative (a Richmond Agitation- - Sedation Scale score between +2 and +4),
- Caregivers of patients who cannot reliably report symptoms of thirst and anxiety
- Caregivers of patients who have a documented hearing deficit.
- Caregivers who do not visit the patient frequently (at least once per day for a minimum of 1 hour as described by nursing staff)
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 |
|---|---|---|
| ICU-CareThe mobile app intervention, ICU-CARE, will consist of 3 separate education modules, each approximately 5-7 minutes in length: (Module #1) ICU orientation, (Module #2) Symptom Assessment, (Module #3) Symptom Management | Behavioural | Intervention with App |
Primary outcome
Enrollment Feasibility of ICU-CARE
Time frame: Through study completion, estimated 3 years.
Total subjects screened, approached, consented and refused
Sustainability of ICU-CARE enrollment
Time frame: Through study completion, estimated 3 years.
Differential attrition rates - the number of subjects in each group that complete all study follow-up measures
Dosage of ICU-CARE
Time frame: Through study completion, estimated 3 years.
Number of doses of the intervention per participant
Acceptability of ICU-CARE
Time frame: Through study completion, estimated 3 years.
Total score of a modified version of the Educational Material Acceptability Instrument. Minimum Score = 11; Maximum Score = 55. Higher score indicates greater acceptance.
16 secondary outcomes
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Activation
Time frame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Self-efficacy
Time frame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Caregiver Process Characteristics - Caregiver Preparedness
Time frame: At study enrollment, 24-48 hours after study enrollment, and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Assessment
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Symptom Management
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Caregiver Anxiety
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Thirst
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Proximal Caregiving Outcomes - Patient Anxiety
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Global Health Status
Time frame: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Anxiety & Depressive Symptoms
Time frame: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver Satisfaction
Time frame: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Caregiver ICU Experience
Time frame: At study enrollment and 2-4 weeks after ICU discharge
Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Agitation
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Patient Pain
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Duration of Ventilation
Time frame: Once every 24 hours from the date the patient is enrolled in the trial to the date the patient is discharged from the ICU, an average of 2 weeks.
Influence of ICU-CARE on Distal Caregiving Outcomes - Sedative Exposure
Time frame: Through study completion, estimated 3 years.
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 3 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Breanna D Hetland, PhD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICU-Care in people with Family and Critical Care, run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 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 3 Jan 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 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?
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?
Enrollment Feasibility of ICU-CARE (time frame: Through study completion, estimated 3 years.). The study lists 4 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 3 Jan 2024.