CommunicationNCT02333396
Improving Communication in the PICU: The Navigate Study
A study testing PICU Supports and Educational Brochure in people with Communication, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 sites in United States.
Trial summary
The project seeks to study the use of an navigator-based intervention called "PICU Supports." The study will test the impact of PICU Supports during and after PICU discharge on parent outcomes (satisfaction with decision making, decision regret, anxiety, depression, post-traumatic stress, health-related quality of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Communication
- What is being tested?
- PICU Supports and Educational Brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Apr 2015to 28 Apr 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Case Patients
- patients < 18 years of age admitted to the PICU
- parents are English or Spanish-speakers and who:
- are likely to require PICU care for at least 24 hours (as determined by the PICU attending physician) or
- have a Pediatric Index of Mortality 2 (PIM2) score ≥ 4% (a PIM2 score predicts risk of mortality based on clinical data collected at the time of admission to the PICU)
- Case patients will be included in the study if one of his/her parents agrees to participate in the study and signs a written consent form.
Show all 15Show fewer
- Parents of case patients
- Parent of an eligible case patient.
- PICU attending gives permission to approach the parent about the study.
- Parent is an English or Spanish speaker.
- Parent provides written consent for participation.
- Healthcare Team Members for the pre-post assessment of team communication and focus group:
- -This group will include as many clinicians in the following groups as possible (identified by the site principal investigator): PICU physicians (attendings and fellows); PICU bedside nurses; PICU Advance Practice Nurses (APNs); hospitalists; subspecialty physicians who consult on PICU patients; subspecialty APNs who consult on PICU patients; PICU respiratory therapist; PICU physical/occupational/speech therapists; and social workers (SWs), chaplains, and case managers who follow PICU patients.
- Healthcare team members for the written feedback/assessment of the intervention:
- -HTMs caring for the case patient at the time of PICU discharge: (PICU attending; PICU fellow; social worker (if involved); chaplain (if involved); bedside nurse; PICU resident, APN or hospitalist; and one to two subspecialty attendings)
Who cannot join
- PICU attending does not give permission to approach the parent about the study.
- Parent is not an English or Spanish speaker.
- Parent does not provide written consent to participate.
- The case patient does not provide assent (if able to provide assent).
- -Healthcare team member that does not regularly care for patients in the PICU.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
The University of Chicago Medicine Comer Children's Hospital
Chicago, Illinois, 60637
About this study
Official title: Improving Communication in the Pediatric Intensive Care Unit for Patients Facing Life-Changing Decisions: The Navigate Study
The project seeks to study the use of an navigator-based intervention called "PICU Supports." The study will test the impact of PICU Supports during and after PICU discharge on parent outcomes (satisfaction with decision making, decision regret, anxiety, depression, post-traumatic stress, health-related quality of life, and complicated bereavement) and on parent and healthcare team member assessments of communication and team collaboration.
Read the detailed description
Parents of children admitted to the PICU often face challenging decisions. Research demonstrates deficiencies in communication in the PICU which could impact decision making. This study team has developed a navigator-based intervention call PICU Supports. PICU Supports aims to provide the following types of support to parents of patients in the PICU: emotional; communication (between healthcare team members and parents/families as well as among healthcare team members ); decision making; transitions out of the PICU (i.e. discharge transitions to a non-PICU hospital bed, a long term care facility, or home); and information. Support is accomplished by navigator engagement with parents and healthcare team members and the guided use of navigator supported ancillary tools provided to parents and healthcare team members as needed. During the patient's PICU stay, the navigator activities and use of ancillary tools is directed by the family's needs. Thus PICU Supports uses a predefined framework of activities and tools to provide individualized support directed by the needs of the parent and the patient situation. This research will test PICU Supports in the clinical setting. This will be accomplished by conducting a pilot study of PICU Supports at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's Hospital), followed by a randomized controlled trial (RCT) comparing the intervention, PICU Supports, to a control, parental receipt of an educational brochure. The RCT will be conducted at Lurie Children's Hospital and at University of Chicago Medicine Comer Children's Hospital (Comer Children's Hospital).
- Conditions
- Communication
- Being tested
- PICU Supports, Educational Brochure
- Keywords
- Navigator, Intervention Study, Randomized Controlled Trial, Pediatric Intensive Care Unit, Decision Making
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICU SupportsOther
The PICU Supports intervention includes navigator activities and ancillary tools. The Navigator activities include: initial visits with the healthcare team members (HTMs) and parents; weekday visits with the parents and feedback to the HTMs as needed; coordination of weekly family meetings between the parents and HTMs; and support during transitions out of the unit. The ancillary tools include: a PICU handbook; a place for parents to keep track of events and their goals; a provider sheet to inform PICU HTMs about important parental issues, concerns or goals; a bedside communication log so parents know which non-PICU HTMs have visited; an end-of-life checklist; a bereavement packet for those whose child dies; and informational resources.
Educational BrochureOther
Parents will receive a short educational brochure with information about the pediatric intensive care unit.
| Study group | Role | What they receive |
|---|---|---|
| PICU Supports | Experimental | Participants will receive the PICU Supports intervention. Receives: Other: PICU Supports |
| Educational Brochure | Active comparator | Participants will receive an educational brochure about the pediatric intensive care unit. Receives: Other: Educational Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction With Decision Making (Percentage of "Excellent" Scores in the Decision Making Domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)
Percentage of "excellent" scores in the decision making domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome
Measured: 3-5 weeks following PICU discharge
Secondary outcomes (13)
Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU)
Measures satisfaction of family who have a child admitted to the Pediatric intensive care unit; Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire mean score, range 0-100, higher score is the better outcome
Measured: 3-5 weeks following PICU discharge
Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)
Subscale: Satisfaction with Care Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome
Measured: 3-5 weeks after PICU Discharge
Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)
Subscale: Satisfaction with Decision Making Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome
Measured: 3-5 weeks after PICU Discharge
Parental Decision Regret (Decision Regret Scale)
Score on the Decision Regret Scale, a 5-item Likert-scale measure of decision regret; minimum=0, maximum=100; higher score indicates more decision regret
Measured: 3-5 weeks after PICU discharge
Parental Anxiety (Anxiety SF8a)
Score on the Anxiety Short Form8a, a 8-item Likert-scale measure of anxiety, the higher the score, the worst the anxiety, T-score range of 37.1 - 83.1.
A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average.
Measured: 3-5 weeks after PICU discharge
Parental Depression (Depression SF8a)
Score on the Depression; Depression Short Form 8a, a 8-item Likert-scale measure of depression; the higher the score, the worst the depression, T-score range of 38.2 - 81.3.
A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average.
Measured: 3-5 weeks after PICU discharge
Parental Impact of Event/Post-Traumatic Distress (Impact of Event Scale-revised)
A measure of post-traumatic distress; Score on the Impact of Event Scale-revised, a 22-item Likert-scale measure of post-traumatic distress; scale range from 0 - 88; higher numbers mean higher trauma or distress; units on a scale
Measured: 3-5 weeks after PICU discharge
Parental Health-related Quality of Life (Global Health Scale) Physical
Measure of global physical health; Physical - Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life; the higher the score the worse global health, t-score range of 16.2 - 67.7.
A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average.
Measured: 3-5 weeks after PICU discharge
Parental Health-related Quality of Life (Global Health Scale) Mental
Measure of Global Mental Health; Mental - Score on the Global Health scale, a 10 item Likert-scale measure of overall health-related quality of life; high scores indicate worse mental health; T-score range 21.1 - 67.6.
A T score of 50 is the average fro the US general population. The SD is 10 with a T-score of 60 being 10 worse than the average and a T-score of 40 being 10 better than the average.
Measured: 3-5 weeks after PICU discharge
Parental Complicated Bereavement (Grief Scale)
Measure of complicated grief in parents after their child's death; Score on the Index of complicated Grief Scale, a 19-item Likert-scale measure of complicated grief; minimum 0, maximum 74; higher numbers mean more complicate grief
Measured: 3-5 weeks after PICU discharge
Parent Report of Healthcare Team Satisfaction (Collaboration and Satisfaction About Care Decisions Scale)
Measure of Satisfaction with Healthcare team collaboaration Subscale Collaboration Satisfaction Score of the Collaboration and Satisfaction about Care Decisions scale, 2 items on a 9-item Likert-scale measure of healthcare team communication satisfaction in ICUs, Score range from 2 - 14 with higher numbers meaning more satisfaction
Measured: 3-5 weeks after PICU Discharge
Parent Report of Healthcare Team Collaboration (Collaboration and Satisfaction About Care Decisions Scale)
Subscale Collaboration Score of the Collaboration and Satisfaction about Care Decisions scale, 7 items on a a 9-item Likert-scale measure of healthcare team communication in ICUs, scale range from 7 - 49. Higher numbers more collaboration.
Measured: 3-5 weeks after PICU Discharge
Parental Report of Acceptability and Perceived Effectiveness of PICU Supports (Likert-scale)
Likert-scale items measuring perceived effectiveness and acceptability of the PICU Supports intervention.
One likert scale item based on previous work. White DB, Cua SM, Walk R, et al. Nurse-led intervention to improve surrogate decision making for patients with advanced critical illness. Am J Crit Care. Nov 2012;21(6):396-409.
How well did the PICU Supports help with communication in the PICU? scale "Not at all helpful" "Not very helpful" "Somewhat helpful" "Extremely Helpful" "Unable to assess" Scored based on percentage of participants who responded "Somewhat Helpful" or Extremely Helpful"
Measured: 3-5 weeks after PICU Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study start6 Apr 2015
- Primary completion28 Apr 2017
- Study completion28 Apr 2017
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 (2)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 442 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Kelly Michelson, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Kelly N Michelson, MD, Principal investigator, Ann & Robert H. Lurie Childrens Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333396
- Sponsor's protocol ID
- The Navigate Study
- Status last verified
- Mar 2025
- First submitted
- 2 Jan 2015
- Last updated
- 26 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ashworth RC, Malone JR, Franklin D, Sorce LR, Clayman ML, Frader J, White DB, Michelson KN. Associations of Patient and Parent Characteristics With Parental Decision Regret in the PICU: A Secondary Analysis of the 2015-2017 Navigate Randomized Comparative Trial. Pediatr Crit Care Med. 2024 Sep 1;25(9):795-803. doi: 10.1097/PCC.0000000000003534. Epub 2024 May 10.
PubMed 38727516Tager JB, Hinojosa JT, LiaBraaten BM, Balistreri KA, Aniciete D, Charleston E, Frader JE, White DB, Clayman ML, Sorce LR, Davies WH, Rothschild CB, Michelson KN; Navigate Study Investigators. Challenges of Families of Patients Hospitalized in the PICU: A Preplanned Secondary Analysis From the Navigate Dataset. Pediatr Crit Care Med. 2024 Feb 1;25(2):128-138. doi: 10.1097/PCC.0000000000003385. Epub 2023 Oct 27.
PubMed 37889100
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Communication in the Pediatric Intensive Care Unit for Patients Facing Life-Changing Decisions: The Navigate Study
- ClinicalTrials.gov ID
- NCT02333396
- Acronym / sponsor ID
- The Navigate Study
- Conditions
- Communication
- Keywords
- Navigator, Intervention Study, Randomized Controlled Trial, Pediatric Intensive Care Unit, Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 442 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 6 Apr 2015 (actual)
- Primary completion
- 28 Apr 2017 (actual)
- Study completion
- 28 Apr 2017 (actual)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Posted 26 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project seeks to study the use of an navigator-based intervention called "PICU Supports." The study will test the impact of PICU Supports during and after PICU discharge on parent outcomes (satisfaction with decision making, decision regret, anxiety, depression, post-traumatic stress, health-related quality of life, and complicated bereavement) and on parent and healthcare team member assessments of communication and team collaboration.
Detailed description
Parents of children admitted to the PICU often face challenging decisions. Research demonstrates deficiencies in communication in the PICU which could impact decision making. This study team has developed a navigator-based intervention call PICU Supports. PICU Supports aims to provide the following types of support to parents of patients in the PICU: emotional; communication (between healthcare team members and parents/families as well as among healthcare team members ); decision making; transitions out of the PICU (i.e. discharge transitions to a non-PICU hospital bed, a long term care facility, or home); and information. Support is accomplished by navigator engagement with parents and healthcare team members and the guided use of navigator supported ancillary tools provided to parents and healthcare team members as needed. During the patient's PICU stay, the navigator activities and use of ancillary tools is directed by the family's needs. Thus PICU Supports uses a predefined framework of activities and tools to provide individualized support directed by the needs of the parent and the patient situation. This research will test PICU Supports in the clinical setting. This will be accomplished by conducting a pilot study of PICU Supports at Ann \& Robert H. Lurie Children's Hospital of Chicago (Lurie Children's Hospital), followed by a randomized controlled trial (RCT) comparing the intervention, PICU Supports, to a control, parental receipt of an educational brochure. The RCT will be conducted at Lurie Children's Hospital and at University of Chicago Medicine Comer Children's Hospital (Comer Children's Hospital).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICU Supports | Experimental | Other: PICU SupportsParticipants will receive the PICU Supports intervention. |
| Educational Brochure | Active comparator | Other: Educational BrochureParticipants will receive an educational brochure about the pediatric intensive care unit. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- Case Patients
- patients < 18 years of age admitted to the PICU
- parents are English or Spanish-speakers and who:
- are likely to require PICU care for at least 24 hours (as determined by the PICU attending physician) or
- have a Pediatric Index of Mortality 2 (PIM2) score ≥ 4% (a PIM2 score predicts risk of mortality based on clinical data collected at the time of admission to the PICU)
Key exclusion criteria (5 listed)
- PICU attending does not give permission to approach the parent about the study.
- Parent is not an English or Spanish speaker.
- Parent does not provide written consent to participate.
- The case patient does not provide assent (if able to provide assent).
- -Healthcare team member that does not regularly care for patients in the PICU.
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 |
|---|---|---|
| PICU SupportsThe PICU Supports intervention includes navigator activities and ancillary tools. The Navigator activities include: initial visits with the healthcare team members (HTMs) and parents; weekday visits with the parents and feedback to the HTMs as needed; coordination of weekly family meetings between the parents and HTMs; and support during transitions out of the unit. The ancillary tools include: a PICU handbook; a place for parents to keep track of events and their goals; a provider sheet to inform PICU HTMs about important parental issues, concerns or goals; a bedside communication log so parents know which non-PICU HTMs have visited; an end-of-life checklist; a bereavement packet for those whose child dies; and informational resources. | Other | PICU Supports |
| Educational BrochureParents will receive a short educational brochure with information about the pediatric intensive care unit. | Other | Educational Brochure |
Primary outcome
Satisfaction With Decision Making (Percentage of "Excellent" Scores in the Decision Making Domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)
Time frame: 3-5 weeks following PICU discharge
Percentage of "excellent" scores in the decision making domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) questionnaire; minimum=0, maximum=100, higher score is better outcome
13 secondary outcomes
Pediatric Family Decision Making Satisfaction in the Intensive Care Unit (pFS-ICU)
Time frame: 3-5 weeks following PICU discharge
Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)
Time frame: 3-5 weeks after PICU Discharge
Parental Satisfaction in the PICU (Score on the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire)
Time frame: 3-5 weeks after PICU Discharge
Parental Decision Regret (Decision Regret Scale)
Time frame: 3-5 weeks after PICU discharge
Parental Anxiety (Anxiety SF8a)
Time frame: 3-5 weeks after PICU discharge
Parental Depression (Depression SF8a)
Time frame: 3-5 weeks after PICU discharge
Parental Impact of Event/Post-Traumatic Distress (Impact of Event Scale-revised)
Time frame: 3-5 weeks after PICU discharge
Parental Health-related Quality of Life (Global Health Scale) Physical
Time frame: 3-5 weeks after PICU discharge
Parental Health-related Quality of Life (Global Health Scale) Mental
Time frame: 3-5 weeks after PICU discharge
Parental Complicated Bereavement (Grief Scale)
Time frame: 3-5 weeks after PICU discharge
Parent Report of Healthcare Team Satisfaction (Collaboration and Satisfaction About Care Decisions Scale)
Time frame: 3-5 weeks after PICU Discharge
Parent Report of Healthcare Team Collaboration (Collaboration and Satisfaction About Care Decisions Scale)
Time frame: 3-5 weeks after PICU Discharge
Parental Report of Acceptability and Perceived Effectiveness of PICU Supports (Likert-scale)
Time frame: 3-5 weeks after PICU Discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38727516Ashworth RC, Malone JR, Franklin D, Sorce LR, Clayman ML, Frader J, White DB, Michelson KN. Associations of Patient and Parent Characteristics With Parental Decision Regret in the PICU: A Secondary Analysis of the 2015-2017 Navigate Randomized Comparative Trial. Pediatr Crit Care Med. 2024 Sep 1;25(9):795-803. doi: 10.1097/PCC.0000000000003534. Epub 2024 May 10.
- Derived from this study: PubMed 37889100Tager JB, Hinojosa JT, LiaBraaten BM, Balistreri KA, Aniciete D, Charleston E, Frader JE, White DB, Clayman ML, Sorce LR, Davies WH, Rothschild CB, Michelson KN; Navigate Study Investigators. Challenges of Families of Patients Hospitalized in the PICU: A Preplanned Secondary Analysis From the Navigate Dataset. Pediatr Crit Care Med. 2024 Feb 1;25(2):128-138. doi: 10.1097/PCC.0000000000003385. Epub 2023 Oct 27.
- 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.
Kelly N Michelson, MD principal investigator
Ann & Robert H. Lurie Childrens Hospital of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICU Supports and Educational Brochure in people with Communication, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 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 15 inclusion and 5 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 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 26 Mar 2025). 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?
Satisfaction With Decision Making (Percentage of "Excellent" Scores in the Decision Making Domain of the Pediatric Family Satisfaction in the Intensive Care Unit (pFS-ICU) Questionnaire) (time frame: 3-5 weeks following PICU discharge). 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 NCT02333396, which also lists 2 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 26 Mar 2025.