Sickle Cell DiseaseNCT03201874
iCanCope With Sickle Cell Pain
A study testing Pain self-management and Education in people with Sickle Cell Disease, run by Seattle Children's Hospital at 4 sites in 2 countries.
Trial summary
The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Pain self-management and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Jan 2018to 31 Aug 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged between 12-18 years
- diagnosed with any type of SCD
- able to speak and read English
- score at least 4 (indicating some days with pain interference over the past month) on the Sickle Cell Pain Burden Interview
- willing and able to complete online measures
Who cannot join
- significant cognitive limitations that would impair their ability to use and understand the iCanCope with SCD program, as per their healthcare provider or parent
- have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Emory University
Atlanta, Georgia, 30322
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents
The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.
Read the detailed description
Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. However, most people with SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. First, the investigators plan to apply a user-centered design approach to develop and refine the iCanCope with SCD program. Second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. The investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. Preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. Third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. These results will enable a future full-scale randomized controlled trial.
- Conditions
- Sickle Cell Disease
- Being tested
- Pain self-management, Education
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain self-managementBehavioural
The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain.
EducationBehavioural
Education about sickle cell disease to increase disease knowledge
| Study group | Role | What they receive |
|---|---|---|
| Education Control | Active comparator | In addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks. Receives: Behavioral: Education |
| Pain Self-Management Intervention | Experimental | In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks. Receives: Behavioral: Pain self-management; Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Diary - Average Daily Pain
App diary using an 11-point numerical rating scale for pain intensity for 7 days Scores range from 0-10 where higher scores indicate a worse outcome
Measured: Baseline,12 weeks, and 26 weeks
Pain Diary - Average Daily Activity Limitations
App diary using Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days Scores range from 0-100 where higher scores mean a worse outcome
Measured: Baseline,12 weeks, and 26 weeks
Adaptive Coping - Coping Attempts
Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome
Measured: Baseline,12 weeks, and 26 weeks
Secondary outcomes (19)
Treatment Acceptability
Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome
Measured: 2 months after starting treatment
Physical and Emotional Functioning - Depressive Symptoms
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Depressive Symptoms T-score, higher scores means higher depressive symptoms. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of depressive symptoms.
Measured: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Anxiety
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Anxiety T-score, higher scores means higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of anxiety.
Measured: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Mobility
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Mobility T-score, higher scores means better mobility. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical mobility limitations.
Measured: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Pain Interference
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Pain Interference T-score, higher scores means more pain interference. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of pain interference.
Measured: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Fatigue
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Fatigue T-score, higher scores means higher levels of fatigue. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of fatigue.
Measured: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Peer Relationships
Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Peer Relationships T-score, higher scores means better peer relationships. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical or reduced quality of peer relationships.
Measured: Baseline,12 weeks, and 26 weeks
Patient Global Impression of Change
Global rating for improvement in pain and functioning Scores range from 1-7 where higher scores mean a better outcome
Measured: 12 weeks and 26 weeks
Parent Protectiveness
Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome
Measured: Baseline,12 weeks, and 26 weeks
Health Services Utilization
Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits
Measured: Baseline and 26 weeks
Parent Psychological Distress
Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome
Measured: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Social Functioning
Bath Adolescent Pain Questionnaire - Parent version, Social Functioning (score range: 0-36). A higher score indicates more impaired functioning for all subscales.
Measured: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Physical Functioning
Bath Adolescent Pain Questionnaire - Parent version Physical Functioning (0-36). A higher score indicates more impaired functioning for all subscales.
Measured: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Depression
Bath Adolescent Pain Questionnaire - Parent version, Depression (0-24). A higher score indicates more impaired functioning for all subscales.
Measured: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, General Anxiety
Bath Adolescent Pain Questionnaire - Parent version, General Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.
Measured: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety
Bath Adolescent Pain Questionnaire - Parent version, Pain Specific Anxiety (0-28). A higher score indicates more impaired functioning for all subscales.
Measured: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Family Functioning
Bath Adolescent Pain Questionnaire - Parent, Family Functioning (0-48). A higher score indicates more impaired functioning for all subscales.
Measured: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Development
Bath Adolescent Pain Questionnaire - Parent version, Development (0-44). A higher score indicates more impaired functioning for all subscales.
Measured: Baseline,12 weeks, and 26 weeks
Treatment Experiences - Child
Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported.
Measured: 12 weeks and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start1 Jan 2018
- Primary completion31 Aug 2022
- Study completion31 Aug 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 Sickle Cell DiseaseStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Emory University, Connecticut Children's Medical Center, University of Mississippi Medical Center, University of Florida, Boston Medical Center, Northwestern University
- Responsible party
- Principal investigator, Tonya Palermo, Seattle Children's Hospital
- Investigators
- Tonya M Palermo, PhD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201874
- Sponsor's protocol ID
- R01HD086978
- Status last verified
- Nov 2023
- First submitted
- 23 Jun 2017
- Last updated
- 13 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Palermo TM, Srinakarin K, Zhou C, Lalloo C, Dampier C, Zempsky WT, Badawy SM, Bakshi N, Ko YJ, Nishat F, Stinson JN. Moderators of digital cognitive-behavioral therapy for youth with sickle cell disease pain: secondary analysis of a randomized controlled trial. Pain. 2025 Mar 13;166(9):e233-e243. doi: 10.1097/j.pain.0000000000003583.
PubMed 40839690Li R, Srinakarin K, Vega R, Murray CB, Palermo TM. Treatment expectations and pain-related outcomes in clinical trials of digital cognitive-behavioral therapy for youth with chronic pain. J Pain. 2025 Mar;28:104791. doi: 10.1016/j.jpain.2025.104791. Epub 2025 Jan 16.
PubMed 39826678Palermo TM, Lalloo C, Zhou C, Dampier C, Zempsky W, Badawy SM, Bakshi N, Ko YJ, Nishat F, Stinson JN. A cognitive-behavioral digital health intervention for sickle cell disease pain in adolescents: a randomized, controlled, multicenter trial. Pain. 2024 Jan 1;165(1):164-176. doi: 10.1097/j.pain.0000000000003009. Epub 2023 Sep 21.
PubMed 37733479Lalloo C, Nishat F, Zempsky W, Bakshi N, Badawy S, Ko YJ, Dampier C, Stinson J, Palermo TM. Characterizing User Engagement With a Digital Intervention for Pain Self-management Among Youth With Sickle Cell Disease and Their Caregivers: Subanalysis of a Randomized Controlled Trial. J Med Internet Res. 2022 Aug 30;24(8):e40096. doi: 10.2196/40096.
PubMed 36040789
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents
- ClinicalTrials.gov ID
- NCT03201874
- Acronym / sponsor ID
- R01HD086978
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, Emory University, Connecticut Children's Medical Center, University of Mississippi Medical Center, University of Florida, Boston Medical Center, Northwestern University
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Posted 13 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.
Detailed description
Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. However, most people with SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. First, the investigators plan to apply a user-centered design approach to develop and refine the iCanCope with SCD program. Second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. The investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. Preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. Third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. These results will enable a future full-scale randomized controlled trial.
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 |
|---|---|---|
| Education Control | Active comparator | Behavioral: EducationIn addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks. |
| Pain Self-Management Intervention | Experimental | Behavioral: Pain self-management, Behavioral: EducationIn addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- aged between 12-18 years
- diagnosed with any type of SCD
- able to speak and read English
- score at least 4 (indicating some days with pain interference over the past month) on the Sickle Cell Pain Burden Interview
- willing and able to complete online measures
Key exclusion criteria (2 listed)
- significant cognitive limitations that would impair their ability to use and understand the iCanCope with SCD program, as per their healthcare provider or parent
- have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.
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 |
|---|---|---|
| Pain self-managementThe program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain. | Behavioural | Pain Self-Management Intervention |
| EducationEducation about sickle cell disease to increase disease knowledge | Behavioural | Education Control, Pain Self-Management Intervention |
Primary outcome
Pain Diary - Average Daily Pain
Time frame: Baseline,12 weeks, and 26 weeks
App diary using an 11-point numerical rating scale for pain intensity for 7 days Scores range from 0-10 where higher scores indicate a worse outcome
Pain Diary - Average Daily Activity Limitations
Time frame: Baseline,12 weeks, and 26 weeks
App diary using Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days Scores range from 0-100 where higher scores mean a worse outcome
Adaptive Coping - Coping Attempts
Time frame: Baseline,12 weeks, and 26 weeks
Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome
19 secondary outcomes
Treatment Acceptability
Time frame: 2 months after starting treatment
Physical and Emotional Functioning - Depressive Symptoms
Time frame: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Anxiety
Time frame: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Mobility
Time frame: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Pain Interference
Time frame: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Fatigue
Time frame: Baseline,12 weeks, and 26 weeks
Physical and Emotional Functioning - Peer Relationships
Time frame: Baseline,12 weeks, and 26 weeks
Patient Global Impression of Change
Time frame: 12 weeks and 26 weeks
Parent Protectiveness
Time frame: Baseline,12 weeks, and 26 weeks
Health Services Utilization
Time frame: Baseline and 26 weeks
Parent Psychological Distress
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Social Functioning
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Physical Functioning
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Depression
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, General Anxiety
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Family Functioning
Time frame: Baseline,12 weeks, and 26 weeks
Child Physical and Emotional Functioning - Parent Report, Development
Time frame: Baseline,12 weeks, and 26 weeks
Treatment Experiences - Child
Time frame: 12 weeks and 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40839690Palermo TM, Srinakarin K, Zhou C, Lalloo C, Dampier C, Zempsky WT, Badawy SM, Bakshi N, Ko YJ, Nishat F, Stinson JN. Moderators of digital cognitive-behavioral therapy for youth with sickle cell disease pain: secondary analysis of a randomized controlled trial. Pain. 2025 Mar 13;166(9):e233-e243. doi: 10.1097/j.pain.0000000000003583.
- Derived from this study: PubMed 39826678Li R, Srinakarin K, Vega R, Murray CB, Palermo TM. Treatment expectations and pain-related outcomes in clinical trials of digital cognitive-behavioral therapy for youth with chronic pain. J Pain. 2025 Mar;28:104791. doi: 10.1016/j.jpain.2025.104791. Epub 2025 Jan 16.
- Derived from this study: PubMed 37733479Palermo TM, Lalloo C, Zhou C, Dampier C, Zempsky W, Badawy SM, Bakshi N, Ko YJ, Nishat F, Stinson JN. A cognitive-behavioral digital health intervention for sickle cell disease pain in adolescents: a randomized, controlled, multicenter trial. Pain. 2024 Jan 1;165(1):164-176. doi: 10.1097/j.pain.0000000000003009. Epub 2023 Sep 21.
- Derived from this study: PubMed 36040789Lalloo C, Nishat F, Zempsky W, Bakshi N, Badawy S, Ko YJ, Dampier C, Stinson J, Palermo TM. Characterizing User Engagement With a Digital Intervention for Pain Self-management Among Youth With Sickle Cell Disease and Their Caregivers: Subanalysis of a Randomized Controlled Trial. J Med Internet Res. 2022 Aug 30;24(8):e40096. doi: 10.2196/40096.
- Individual participant dataSharing planned: Undecided
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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.
Tonya M Palermo, PhD principal investigator
Seattle Children's Hospital
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain self-management and Education in people with Sickle Cell Disease, run by Seattle Children's Hospital at 4 sites in 2 countries.
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 5 inclusion and 2 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 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, 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?
Yes. Results are posted in the registry (first posted 13 Dec 2023). 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?
Pain Diary - Average Daily Pain (time frame: Baseline,12 weeks, and 26 weeks). 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 NCT03201874, 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 13 Dec 2023.