Children, OnlyNCT05513235
Feasibility Study of a Mobile Digital Personal Health Record for Family-Centered Care Coordination for Children and Youth With Special Healthcare Needs
A study testing Digital personal health record in people with Children, Only and Children and Youth With Special Healthcare Needs, run by Duke University at 1 site in United States.
Trial summary
A Fast Healthcare Interoperability Resources (FHIR)-enabled digital personal health record mobile app has the potential to enhance care coordination for families of children and youth with special healthcare needs (CYSHCN) and to inform improvements in family-centered care coordination that will be highly impactful… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Children, Only, Children and Youth With Special Healthcare Needs
- What is being tested?
- Digital personal health record
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2022to 15 Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult parent/legal guardian (age 18 or older) who is a primary caregiver for a CYSHCN aged 0-16 years
- Established care for their child/youth at a participating Duke Pediatrics Primary Care clinic: North Durham, South Durham,Brier Creek or Duke Med-Peds Primary Care sites (established = one or more completed visits in the past 12 months at the clinic)
- High level of complex medical needs that could benefit from additional care coordination support (determined by clinical provider at the participating clinic site)
- Primary care provider enrolled in the study as a provider participant/clinical provider site champion
- Active Duke MyChart (online EHR patient portal) account
- Full proxy access activated/enabled for parent to the child/youth's medical record in Epic
- Apple iOS device compatible with Caremap app requirements at time of consent
Who cannot join
- Non-English speaking
- Patients living in long-term, congregate settings - e.g., living in institutionalized settings such as long-term care facility, nursing/long-term rehab facilities
- Child is a ward of the state
- Lacks requisite technology to access and use mobile app (e.g., device/tablet/smartphone, home internet, active Epic MyChart account)
- Lack of decision-making capacity (parent/caregiver or adult patient, clinician-determined)
Trial locations and contacts
1 site in 1 country.
About this study
A Fast Healthcare Interoperability Resources (FHIR)-enabled digital personal health record mobile app has the potential to enhance care coordination for families of children and youth with special healthcare needs (CYSHCN) and to inform improvements in family-centered care coordination that will be highly impactful for populations of patients with complex health needs across the age spectrum.
The purpose of this study is to evaluate the feasibility of a digital personal health record (PHR) mobile application integrated with electronic health records by FHIR data standards to enhance care coordination for families of CYSHCN. The study will enroll 40 families (adult parents/caregivers) of CYSHCN in pediatric primary care clinics to use the digital PHR mobile application as a tool for coordinating their child's care over a 6-month period. Using a single group, non-randomized study design and convergent mixed methods analyses, the study will: (a) determine the feasibility of FHIR-enabled integration of the mobile application with electronic health records for care coordination; (b) identify barriers and facilitators to implementation in real-world settings; and (c) examine associations between level of app adoption by families and family-reported outcome measures.
Read the detailed description
Coordinating complex care across multiple providers and services can be stressful and isolating for families of children and youth with special healthcare needs (CYSHCN); thus, better care coordination solutions are needed. Digital personal health records (PHRs) that allow families to securely access, manage, and share their child's health data across multiple information and electronic health record (EHR) systems are promising solutions. Fast Healthcare Interoperability Resources (FHIR)-an application programming interface (API) standard that represents and exchanges health information-are central to digital PHRs being able to fulfill their promise. Despite their importance, FHIR technologies are not yet widely adopted. The researchers previously collaborated with Boston Children's Hospital on development of Caremap, a FHIR-enabled digital PHR mobile app that was co-designed with families and clinicians, to coordinate care for CYSHCN. Caremap has been positively reviewed by families in preliminary testing, and this followup research will implement and evaluate the Caremap mobile app in a real-world setting.
The specific aims of the study are as follows:
- Evaluate the feasibility of a digital PHR mobile application with FHIR-enabled EHR integration to coordinate care for CYSHCN.
- Identify barriers and facilitators of mobile app implementation via a mixed-methods evaluation.
- Explore associations between mobile app adoption by families and family-reported outcomes.
The study will enroll 40 families (adult parents/caregivers) of CYSHCN in pediatric primary care clinics to use the digital PHR mobile application as a tool for coordinating their child's care over a 6-month period. Using a mixed-methods design, researchers will evaluate quantitative feasibility data and qualitative data from semi-structured interviews with families and providers and family stakeholder engagement panels to identify implementation barriers and facilitators. Using pre/post analyses of baseline and 6-month family-reported survey measures, they will explore associations between app adoption and family-reported outcomes.
If successful, the findings will support a future multisite, randomized trial to evaluate the effectiveness of enhanced care coordination with a digital PHR mobile app compared to usual care coordination. Due to similarities in needs between CYSHCN and adults with multiple chronic conditions, the study's findings will inform improvements in family-centered care coordination that will be highly impactful for complex populations across the age spectrum.
- Being tested
- Digital personal health record
- Keywords
- Care coordination, Digital health, Mobile application, Primary care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital personal health recordOther
The digital personal health record is a mobile application ('app') entitled Caremap. The mobile app will be downloaded and accessible by parents/caregivers to help coordinate care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Parents of eligible children and youth with special healthcare needs will use a digital personal record mobile application to coordinate care for six months. Receives: Other: Digital personal health record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical feasibility (FHIR data transfer EHR to app)
Quantitative measurement of technical feasibility assessed by success rate of FHIR-enabled EHR data transfer to app
Measured: Up to 6 months
Technical feasibility (FHIR data transfer app to provider dashboard)
Quantitative measurement of technical feasibility processes assessed by success rate of FHIR-enabled transfer of family-reported health insights from app to EHR provider dashboard
Measured: Up to 6 months
Implementation (feasibility)
User-reported surveys of implementation outcomes assessed by the Feasibility of Intervention Measure (FIM), a 4-item scale that assesses whether a given method or condition can be successfully used in a specific setting. Responses to all survey items use a 5-point Likert scale from minimum 1 (completely disagree) to maximum 5 (completely agree). Higher scores are correlated with more positive responses.
Measured: End of study (6 months)
Implementation (acceptability)
User-reported surveys of implementation outcomes assessed by the Acceptability of Intervention Measure (AIM), a 4-item scale that assesses whether a treatment or condition is satisfactory or agreeable to stakeholders. Responses to all survey items use a 5-point Likert scale from minimum 1 (completely disagree) to maximum 5 (completely agree). Higher scores are correlated with more positive responses.
Measured: End of study (6 months)
Implementation (appropriateness)
User-reported surveys of implementation outcomes assessed by the Intervention Appropriateness Measure (IAM), a 4-item scale that assesses perceived compatibility or fit of a treatment or condition for a given setting or issue. Responses to all survey items use a 5-point Likert scale from minimum 1 (completely disagree) to maximum 5 (completely agree). Higher scores are correlated with more positive responses.
Measured: End of study (6 months)
Change in parent/caregiver-reported degree of care integration, as measured by Pediatric Integrated Care Survey (PIC)
Parent/caregiver report of experiences with care integration will be measured using the validated core 19-item PICS instrument. A composite score is calculated separately for each of the 5 survey constructs: access, communication, family impact, care goal creation, and team functioning.
Measured: Baseline, 6 months
Change in health-related quality of life (HR-QOL)
Parent/caregiver report of child's health-related QOL using the 9-item PROMIS Global 7+2 HR-QOL instrument, as well as a 2-item instrument assessing parent/caregiver perspectives on the impact of the child's conditions on their own and the parent/caregiver's usual activities and routines
Measured: Baseline, 3 months, 6 months
Change in usability, as measured by the System Usability Scale (SUS) (provider)
Provider report of experience and usability of the mobile app's provider dashboard using the 10-item SUS. This scale assesses participants' views of the usability of the app using a 5-point Likert scale from strongly agree to strongly disagree. Baseline version assesses their views on how usable they think the app will be, while the post version assesses their views on how usable the app actually was.
Measured: Baseline, 6 months
Net promoter score (NPS) (provider)
Provider-reported degree to which they would recommend the mobile app for use by others. NPS is a single item that measures the loyalty of customers to a company. NPS scores are measured with a single-question survey and reported with a number from the range -100 to +100, a higher score is desirable.
Measured: End of study (6 months)
Secondary outcomes (8)
Change in usability, as measured by the System Usability Scale (SUS) (parent/caregiver)
Parent/caregiver report of experience and usability of the mobile app using the 10-item SUS. This scale assesses participants' views of the usability of the app using a 5-point Likert scale from strongly agree to strongly disagree. Baseline version assesses their views on how usable they think the app will be, while the post version assesses their views on how usable the app actually was.
Measured: Baseline, 6 months
Change in caregiver strain, as measured by the Caregiver Strain Questionnaire (Short Form 7; CGSQ-SF7)
Parent/caregiver report of degree of strain experienced as a result of their child's health with responses on a 5-point scale (1=not a problem at all; 5=very much a problem).
Measured: Baseline, 3 months, 6 months
Change in confidence in avoiding hospitalization
Parent/caregiver-reported confidence in ability to avoid unplanned hospitalization in the next one month
Measured: Baseline, 3 months, 6 months
Net promoter score (NPS) (parent/caregiver)
Parent/caregiver-reported degree to which they would recommend the mobile app for use by others. NPS is a single item that measures the loyalty of customers to a company. NPS scores are measured with a single-question survey and reported with a number from the range -100 to +100, a higher score is desirable.
Measured: End of study (6 months)
Change in global health status
Parent/caregiver report of their child's overall health status on a single item: 1 (poor) to 10 (excellent) numeric rating scale.
Measured: Weekly, up to 6 months
Adoption (family engagement)
Quantitative measurement of family engagement with the app, assessed by weekly app log-ins by families.
Measured: Up to 6 months
Adoption (provider engagement)
Quantitative measurement of provider engagement, assessed by count of views of EHR provider dashboard.
Measured: Up to 6 months
Adoption (app prescriptions)
Quantitative measurement of prescription of the app to patients, assessed by count of times mobile app prescribed by provider for use.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start6 Oct 2022
- Primary completion30 Sep 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Children, OnlyStudies of the same condition, open and under way.
- More trials run by Duke 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
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized single group feasibility study design
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- David Y Ming, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513235
- Sponsor's protocol ID
- Pro00109514
- Other IDs
- R21HS028699
- Status last verified
- Nov 2024
- First submitted
- 18 Aug 2022
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ming DY, Wong W, Jones KA, Antonelli RC, Gujral N, Gonzales S, Rogers U, Ratliff W, Shah N, King HA. Feasibility of Implementation of a Mobile Digital Personal Health Record to Coordinate Care for Children and Youth With Special Health Care Needs in Primary Care: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2023 Sep 20;12:e46847. doi: 10.2196/46847.
PubMed 37728977
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Mobile Digital Personal Health Record for Family-Centered Care Coordination for Children and Youth With Special Healthcare Needs
- ClinicalTrials.gov ID
- NCT05513235
- Acronym / sponsor ID
- Pro00109514
- Keywords
- Care coordination, Digital health, Mobile application, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Boston Children's Hospital
- Study start
- 6 Oct 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 24 Aug 2022 (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.
A Fast Healthcare Interoperability Resources (FHIR)-enabled digital personal health record mobile app has the potential to enhance care coordination for families of children and youth with special healthcare needs (CYSHCN) and to inform improvements in family-centered care coordination that will be highly impactful for populations of patients with complex health needs across the age spectrum.
The purpose of this study is to evaluate the feasibility of a digital personal health record (PHR) mobile application integrated with electronic health records by FHIR data standards to enhance care coordination for families of CYSHCN. The study will enroll 40 families (adult parents/caregivers) of CYSHCN in pediatric primary care clinics to use the digital PHR mobile application as a tool for coordinating their child's care over a 6-month period. Using a single group, non-randomized study design and convergent mixed methods analyses, the study will: (a) determine the feasibility of FHIR-enabled integration of the mobile application with electronic health records for care coordination; (b) identify barriers and facilitators to implementation in real-world settings; and (c) examine associations between level of app adoption by families and family-reported outcome measures.
Detailed description
Coordinating complex care across multiple providers and services can be stressful and isolating for families of children and youth with special healthcare needs (CYSHCN); thus, better care coordination solutions are needed. Digital personal health records (PHRs) that allow families to securely access, manage, and share their child's health data across multiple information and electronic health record (EHR) systems are promising solutions. Fast Healthcare Interoperability Resources (FHIR)-an application programming interface (API) standard that represents and exchanges health information-are central to digital PHRs being able to fulfill their promise. Despite their importance, FHIR technologies are not yet widely adopted. The researchers previously collaborated with Boston Children's Hospital on development of Caremap, a FHIR-enabled digital PHR mobile app that was co-designed with families and clinicians, to coordinate care for CYSHCN. Caremap has been positively reviewed by families in preliminary testing, and this followup research will implement and evaluate the Caremap mobile app in a real-world setting.
The specific aims of the study are as follows:
- Evaluate the feasibility of a digital PHR mobile application with FHIR-enabled EHR integration to coordinate care for CYSHCN.
- Identify barriers and facilitators of mobile app implementation via a mixed-methods evaluation.
- Explore associations between mobile app adoption by families and family-reported outcomes.
The study will enroll 40 families (adult parents/caregivers) of CYSHCN in pediatric primary care clinics to use the digital PHR mobile application as a tool for coordinating their child's care over a 6-month period. Using a mixed-methods design, researchers will evaluate quantitative feasibility data and qualitative data from semi-structured interviews with families and providers and family stakeholder engagement panels to identify implementation barriers and facilitators. Using pre/post analyses of baseline and 6-month family-reported survey measures, they will explore associations between app adoption and family-reported outcomes.
If successful, the findings will support a future multisite, randomized trial to evaluate the effectiveness of enhanced care coordination with a digital PHR mobile app compared to usual care coordination. Due to similarities in needs between CYSHCN and adults with multiple chronic conditions, the study's findings will inform improvements in family-centered care coordination that will be highly impactful for complex populations across the age spectrum.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized single group feasibility study design
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Digital personal health recordParents of eligible children and youth with special healthcare needs will use a digital personal record mobile application to coordinate care for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult parent/legal guardian (age 18 or older) who is a primary caregiver for a CYSHCN aged 0-16 years
- Established care for their child/youth at a participating Duke Pediatrics Primary Care clinic: North Durham, South Durham,Brier Creek or Duke Med-Peds Primary Care sites (established = one or more completed visits in the past 12 months at the clinic)
- High level of complex medical needs that could benefit from additional care coordination support (determined by clinical provider at the participating clinic site)
- Primary care provider enrolled in the study as a provider participant/clinical provider site champion
- Active Duke MyChart (online EHR patient portal) account
Key exclusion criteria (5 listed)
- Non-English speaking
- Patients living in long-term, congregate settings - e.g., living in institutionalized settings such as long-term care facility, nursing/long-term rehab facilities
- Child is a ward of the state
- Lacks requisite technology to access and use mobile app (e.g., device/tablet/smartphone, home internet, active Epic MyChart account)
- Lack of decision-making capacity (parent/caregiver or adult patient, clinician-determined)
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 |
|---|---|---|
| Digital personal health recordThe digital personal health record is a mobile application ('app') entitled Caremap. The mobile app will be downloaded and accessible by parents/caregivers to help coordinate care. | Other | Intervention |
Primary outcome
Technical feasibility (FHIR data transfer EHR to app)
Time frame: Up to 6 months
Quantitative measurement of technical feasibility assessed by success rate of FHIR-enabled EHR data transfer to app
Technical feasibility (FHIR data transfer app to provider dashboard)
Time frame: Up to 6 months
Quantitative measurement of technical feasibility processes assessed by success rate of FHIR-enabled transfer of family-reported health insights from app to EHR provider dashboard
Implementation (feasibility)
Time frame: End of study (6 months)
User-reported surveys of implementation outcomes assessed by the Feasibility of Intervention Measure (FIM), a 4-item scale that assesses whether a given method or condition can be successfully used in a specific setting. Responses to all survey items use a 5-point Likert scale from minimum 1 (completely disagree) to maximum 5 (completely agree). Higher scores are correlated with more positive responses.
Implementation (acceptability)
Time frame: End of study (6 months)
User-reported surveys of implementation outcomes assessed by the Acceptability of Intervention Measure (AIM), a 4-item scale that assesses whether a treatment or condition is satisfactory or agreeable to stakeholders. Responses to all survey items use a 5-point Likert scale from minimum 1 (completely disagree) to maximum 5 (completely agree). Higher scores are correlated with more positive responses.
Implementation (appropriateness)
Time frame: End of study (6 months)
User-reported surveys of implementation outcomes assessed by the Intervention Appropriateness Measure (IAM), a 4-item scale that assesses perceived compatibility or fit of a treatment or condition for a given setting or issue. Responses to all survey items use a 5-point Likert scale from minimum 1 (completely disagree) to maximum 5 (completely agree). Higher scores are correlated with more positive responses.
Change in parent/caregiver-reported degree of care integration, as measured by Pediatric Integrated Care Survey (PIC)
Time frame: Baseline, 6 months
Parent/caregiver report of experiences with care integration will be measured using the validated core 19-item PICS instrument. A composite score is calculated separately for each of the 5 survey constructs: access, communication, family impact, care goal creation, and team functioning.
Change in health-related quality of life (HR-QOL)
Time frame: Baseline, 3 months, 6 months
Parent/caregiver report of child's health-related QOL using the 9-item PROMIS Global 7+2 HR-QOL instrument, as well as a 2-item instrument assessing parent/caregiver perspectives on the impact of the child's conditions on their own and the parent/caregiver's usual activities and routines
Change in usability, as measured by the System Usability Scale (SUS) (provider)
Time frame: Baseline, 6 months
Provider report of experience and usability of the mobile app's provider dashboard using the 10-item SUS. This scale assesses participants' views of the usability of the app using a 5-point Likert scale from strongly agree to strongly disagree. Baseline version assesses their views on how usable they think the app will be, while the post version assesses their views on how usable the app actually was.
Net promoter score (NPS) (provider)
Time frame: End of study (6 months)
Provider-reported degree to which they would recommend the mobile app for use by others. NPS is a single item that measures the loyalty of customers to a company. NPS scores are measured with a single-question survey and reported with a number from the range -100 to +100, a higher score is desirable.
8 secondary outcomes
Change in usability, as measured by the System Usability Scale (SUS) (parent/caregiver)
Time frame: Baseline, 6 months
Change in caregiver strain, as measured by the Caregiver Strain Questionnaire (Short Form 7; CGSQ-SF7)
Time frame: Baseline, 3 months, 6 months
Change in confidence in avoiding hospitalization
Time frame: Baseline, 3 months, 6 months
Net promoter score (NPS) (parent/caregiver)
Time frame: End of study (6 months)
Change in global health status
Time frame: Weekly, up to 6 months
Adoption (family engagement)
Time frame: Up to 6 months
Adoption (provider engagement)
Time frame: Up to 6 months
Adoption (app prescriptions)
Time frame: Up to 6 months
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 19 Nov 2024.
- Derived from this study: PubMed 37728977Ming DY, Wong W, Jones KA, Antonelli RC, Gujral N, Gonzales S, Rogers U, Ratliff W, Shah N, King HA. Feasibility of Implementation of a Mobile Digital Personal Health Record to Coordinate Care for Children and Youth With Special Health Care Needs in Primary Care: Protocol for a Mixed Methods Study. JMIR Res Protoc. 2023 Sep 20;12:e46847. doi: 10.2196/46847.
- 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.
David Y Ming, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital personal health record in people with Children, Only and Children and Youth With Special Healthcare Needs, run by Duke University 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 7 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 19 Nov 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?
Technical feasibility (FHIR data transfer EHR to app) (time frame: Up to 6 months). The study lists 9 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 NCT05513235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.