DementiaEarly Phase 1NCT05465551
Stress Management Toolkit for People Living With Dementia and Their Care Partners
A Early Phase 1 study testing Stress Management Toolkit in people with Dementia and Stress, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia, Stress, Caregiver Burden
- What is being tested?
- Stress Management Toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2022to 6 Jan 2025
- Phase
- Early Phase 1
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 60 years and over with a diagnosis of dementia of any type
- able to express self verbally
- English speaking.
- age 21 years and older
- identify as a primary care partner of someone with dementia
- English speaking
Who cannot join
- has a hearing or visual impairment that limits their ability to participate in the screening process or to participate in a focus group.
- has a hearing or visual impairment that limits their ability to participate in the screening process or to participate in a focus group.
- Dyadic eligibility criteria include:
- both the PLWD and care partner reside in the same household or personal residence in the community
- dyad has lived together for at least 1 month
- dyad has telephone or internet access
Show all 11Show fewer
- Dyads will be excluded if they reside in assisted living or other long-term care setting.
- Dyads participating in user-testing phase will also be excluded if either member:
- currently receives cytokine-based therapy
- currently receives radiation therapy to the salivary glands or thyroid
- are diagnosed with Cushing or Addison's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Caregiver and dementia community support organizations
Durham, North Carolina, 27705
About this study
Official title: Development of a Dyadic Stress Management Toolkit for People Living With Dementia and Their Care Partners
The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home.
A human-centered design approach will be used to develop and user-test a prototype of a dyadic, tangible stress-management toolkit with and for PLWD and their care partners; and to explore the feasibility of collecting several stress-related outcomes. A total of 4 focus groups (n=3-4 dyads/group) will be convened to explore the experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. Ten dyads who were not involved in prototype development will then use the toolkit for 2 weeks. Feedback on usability, feasibility, and acceptability will be collected through questionnaires (end of weeks 1 and 2) and 3 focus groups (3-4 dyads/group at end of week 2). We will collect stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and saliva biospecimens from participants with dementia and their care partners at baseline and end of week 2, to explore their utility as endpoints in a future toolkit intervention that uses a single-arm, pre-post study design. Results will yield valuable data to support development and preliminary testing of a stress management toolkit intervention in a future pilot study.
This study involves human subjects and is expected to yield no more than minimal risk. Tools eligible for the toolkit must have demonstrated high degrees of safety in prior research. Major risks for participation include the potential for negative emotional responses to focus group discussions and surveys pertaining to stress, excess time burden to participate in the study, and breach of confidentiality. It is not anticipated, but there is a potential for physical discomfort if tools are not used as directed, which is why the toolkits will include a user guide outlining safety information, which a research team member will review with each participant prior to use.
- Conditions
- Dementia, Stress, Caregiver Burden
- Being tested
- Stress Management Toolkit
- Keywords
- Nonpharmacological interventions
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress Management ToolkitCombination product
The toolkit will be a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home. Potential tools for the toolkit includes low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. The tookit will also include user-safety guidelines and directions on how to use each tool. Tools will be included for participants with dementia and care partners.
| Study group | Role | What they receive |
|---|---|---|
| Stress Management Toolkit Prototype Development | No intervention | 3-4 qualitative focus groups (n=3-4 dyads/group) will be held to explore experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools (e.g., weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy, bright light therapy devices, massage and acupressure tools). |
| Stress Management Toolkit Prototype User Testing | Experimental | 10 dyads will use the toolkit for 2 weeks in their own homes. Feedback on usability, feasibility, and acceptability will be collected through questionnaires and focus groups. Stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and salivary cortisol biospecimens will be collected at baseline and end of week 2, to explore their utility as endpoints in a future pilot study to examine efficacy. Receives: Combination Product: Stress Management Toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of toolkit use
Number of days toolkit was used over the last week (range 0-7) will be assessed among participants enrolled in user-testing arm.
Measured: End of week 1 of user-testing period
Frequency of toolkit use
Number of days toolkit was used over the last week (range 0-7) will be assessed among participants enrolled in user-testing arm.
Measured: End of week 2 of user-testing period
Enrollment rate
Percentage of participant dyads enrolled/dyads screened in user-testing arm.
Measured: Through study completion, an average of 1 year
Withdrawal rate
Percentage of dyads that withdraw/dyads enrolled in user-testing arm.
Measured: Through study completion, an average of 1 year
Frequency of adverse events and injuries
Number of adverse events and injuries reported in user-testing arm.
Measured: Through study completion, an average of 1 year
Participant satisfaction with toolkit, as assessed using a toolkit satisfaction scale
Investigator developed multi-item satisfaction scale will include Likert-scaled items pertaining to satisfaction with design and delivery of the toolkit among participants in the user-testing arm; item ranges 1=not satisfied at all to 5 very satisfied). Scores will be averaged to yield and overall satisfaction score with higher scores indicating a greater degree of satisfaction.
Measured: Within 1 week after user-testing period
Participant perceived benefit with toolkit, as assessed using a toolkit benefit scale
Investigator developed multi-item benefit scale will include Likert-scaled items pertaining to perceived benefit from the toolkit among participants in the user-testing arm; item ranges 1=not beneficial at all to 5 very beneficial). Scores will be averaged to yield and overall benefit score with higher scores indicating a greater degree of benefit.
Measured: Within 1 week after user-testing period
Secondary outcomes (8)
Percentage of participant completion of neuropsychiatric symptoms of dementia outcome measure, as assessed using the Neuropsychiatric Inventory-Questionnaire
Percentage of participant completion for this measure will be calculated for participants enrolled in the user-testing arm (Number of participants who complete the measure at baseline/total number of participants enrolled in user-testing arm). NPI assesses severity (1=mild, 2=moderate, 3=severe) and caregiver distress (range 0=not distressing at all to 5 extreme or very severe) of 12 domains of neuropsychiatric symptoms of dementia. Higher scores indicate more severe or distressing symptoms.
Measured: Baseline, pre user-testing period
Percentage of participant completion of neuropsychiatric symptoms of dementia outcome measure, as assessed using the Neuropsychiatric Inventory-Questionnaire
Percentage of participant completion for this measure will be calculated for participants enrolled in the user-testing arm (Number of participants who complete the measure at post user-testing/total number of participants enrolled in user-testing arm). NPI assesses severity (1=mild, 2=moderate, 3=severe) and caregiver distress (range 0=not distressing at all to 5 extreme or very severe) of 12 domains of neuropsychiatric symptoms of dementia. Higher scores indicate more severe or distressing symptoms.
Measured: Within 1 week after user-testing period
Percentage of participant completion of caregiver stress outcome measure, as assessed using the Perceived Stress Scale
Percentage of participant completion for this measure will be calculated for participants enrolled in the user-testing arm (Number of participants who complete the measure at baseline/total number of participants enrolled in user-testing arm). The Perceived Stress Scale is a 10-item measure that assesses recent stress-related thoughts and feelings on 5-point scale with higher scores indicating higher levels of stress.
Measured: Baseline, pre user-testing period
Percentage of participant completion of caregiver stress outcome measure, as assessed using the Perceived Stress Scale
Percentage of participant completion for this measure will be calculated for participants enrolled in the user-testing arm (Number of participants who complete the measure at post user-testing/total number of participants enrolled in user-testing arm). The Perceived Stress Scale is a 10-item measure that assesses recent stress-related thoughts and feelings on 5-point scale with higher scores indicating higher levels of stress.
Measured: Within 1 week after user-testing period
Percentage of participant completion of dyadic relationship strain outcome measure, as assessed using the Dyadic Relationship Scale
Percentage of participant completion for this measure will be calculated for participants enrolled in the user-testing arm (Number of participants who complete the measure at baseline/total number of participants enrolled in user-testing arm). The Dyadic Relationship Scale includes a care recipient 10-item version and care partner specific 11-item version. Both scales measure dyadic strain and positive dyadic interaction. Total scores range from 0-30 for the care recipient version, and 0-33 for care partner specific, with higher scores indicative of higher levels of dyadic strain.
Measured: Baseline, pre user-testing period
Percentage of participant completion of dyadic relationship strain outcome measure, as assessed using the Dyadic Relationship Scale
Percentage of participant completion for this measure will be calculated for participants enrolled in the user-testing arm (Number of participants who complete the measure at post user-testing/total number of participants enrolled in user-testing arm). The Dyadic Relationship Scale includes a care recipient 10-item version and care partner specific 11-item version. Both scales measure dyadic strain and positive dyadic interaction. Total scores range from 0-30 for the care recipient version, and 0-33 for care partner specific, with higher scores indicative of higher levels of dyadic strain.
Measured: Within 1 week after user-testing period
Percentage of participant completion of physiologic stress outcome measure, as assessed through salivary cortisol biospecimens
Percentage of participant completion for this measure will be calculated for participants enrolled in the user-testing arm (Total number of biospecimen samples collected among participants at baseline/total number of participants enrolled in user-testing arm*5).
Salivary cortisol biospecimens will be collected using salivary sample kits sent to participants' homes by mail. Participants with dementia and care partners will each be asked to collect 5 samples at baseline and will collect samples themselves in their own homes with guidance and support from research team. Samples will be mailed back to research team using preaddressed, prestamped envelopes.
Measured: Baseline, pre user-testing period
Percentage of participant completion of physiologic stress outcome measure, as assessed through salivary cortisol biospecimens
Percentage of participant completion for this measure will be calculated for participants enrolled in the user-testing arm (Total number of biospecimen samples collected among participants at post user-testing/total number of participants enrolled in user-testing arm*5).
Salivary cortisol biospecimens will be collected using salivary sample kits sent to participants' homes by mail. Participants with dementia and care partners will each be asked to collect 5 samples at post user-testing and will collect samples themselves in their own homes with guidance and support from research team. Samples will be mailed back to research team using preaddressed, prestamped envelopes.
Measured: Within 1 week after user-testing period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start20 Dec 2022
- Primary completion6 Jan 2025
- Study completion6 Jan 2025
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 DementiaStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Melissa L Harris, PhD, Principal investigator, Duke University School of NursingSusan N Hastings, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465551
- Sponsor's protocol ID
- Pro00110944
- Other IDs
- P30AG072958
- Status last verified
- Feb 2025
- First submitted
- 27 Jun 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harris M, Van Houtven C, Hastings S. Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. JMIR Res Protoc. 2022 Dec 14;11(12):e43098. doi: 10.2196/43098.
PubMed 36399169
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Dyadic Stress Management Toolkit for People Living With Dementia and Their Care Partners
- ClinicalTrials.gov ID
- NCT05465551
- Acronym / sponsor ID
- Pro00110944
- Conditions
- Dementia, Stress, Caregiver Burden
- Keywords
- Nonpharmacological interventions
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Dec 2022 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 20 Jul 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.
The purpose of this study is to develop a prototype of a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home.
A human-centered design approach will be used to develop and user-test a prototype of a dyadic, tangible stress-management toolkit with and for PLWD and their care partners; and to explore the feasibility of collecting several stress-related outcomes. A total of 4 focus groups (n=3-4 dyads/group) will be convened to explore the experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. Ten dyads who were not involved in prototype development will then use the toolkit for 2 weeks. Feedback on usability, feasibility, and acceptability will be collected through questionnaires (end of weeks 1 and 2) and 3 focus groups (3-4 dyads/group at end of week 2). We will collect stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and saliva biospecimens from participants with dementia and their care partners at baseline and end of week 2, to explore their utility as endpoints in a future toolkit intervention that uses a single-arm, pre-post study design. Results will yield valuable data to support development and preliminary testing of a stress management toolkit intervention in a future pilot study.
This study involves human subjects and is expected to yield no more than minimal risk. Tools eligible for the toolkit must have demonstrated high degrees of safety in prior research. Major risks for participation include the potential for negative emotional responses to focus group discussions and surveys pertaining to stress, excess time burden to participate in the study, and breach of confidentiality. It is not anticipated, but there is a potential for physical discomfort if tools are not used as directed, which is why the toolkits will include a user guide outlining safety information, which a research team member will review with each participant prior to use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Management Toolkit Prototype Development | No intervention | –3-4 qualitative focus groups (n=3-4 dyads/group) will be held to explore experiences, perceptions, preferences, and recommendations of dementia-caring dyads regarding stress, stress management, and key components and features of a stress management toolkit. Eligible tools for the toolkit include low burden, high safety tools (e.g., weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy, bright light therapy devices, massage and acupressure tools). |
| Stress Management Toolkit Prototype User Testing | Experimental | Combination Product: Stress Management Toolkit10 dyads will use the toolkit for 2 weeks in their own homes. Feedback on usability, feasibility, and acceptability will be collected through questionnaires and focus groups. Stress-related, participant-reported outcomes (e.g., neuropsychiatric symptoms of dementia, caregiver stress, dyadic relationship strain), and salivary cortisol biospecimens will be collected at baseline and end of week 2, to explore their utility as endpoints in a future pilot study to examine efficacy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 60 years and over with a diagnosis of dementia of any type
- able to express self verbally
- English speaking.
- age 21 years and older
- identify as a primary care partner of someone with dementia
Key exclusion criteria (11 listed)
- has a hearing or visual impairment that limits their ability to participate in the screening process or to participate in a focus group.
- has a hearing or visual impairment that limits their ability to participate in the screening process or to participate in a focus group.
- both the PLWD and care partner reside in the same household or personal residence in the community
- dyad has lived together for at least 1 month
- dyad has telephone or internet access
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 |
|---|---|---|
| Stress Management ToolkitThe toolkit will be a home-based, dyadic tangible toolkit comprised of simple tools to help people living with dementia (PLWD) and their care partners manage stress at home. Potential tools for the toolkit includes low burden, high safety tools such as weighted blankets, robotic pets and baby dolls, guided journals, aromatherapy and bright light therapy devices, and massage and acupressure tools. The tookit will also include user-safety guidelines and directions on how to use each tool. Tools will be included for participants with dementia and care partners. | Combination product | Stress Management Toolkit Prototype User Testing |
Primary outcome
Frequency of toolkit use
Time frame: End of week 1 of user-testing period
Number of days toolkit was used over the last week (range 0-7) will be assessed among participants enrolled in user-testing arm.
Frequency of toolkit use
Time frame: End of week 2 of user-testing period
Number of days toolkit was used over the last week (range 0-7) will be assessed among participants enrolled in user-testing arm.
Enrollment rate
Time frame: Through study completion, an average of 1 year
Percentage of participant dyads enrolled/dyads screened in user-testing arm.
Withdrawal rate
Time frame: Through study completion, an average of 1 year
Percentage of dyads that withdraw/dyads enrolled in user-testing arm.
Frequency of adverse events and injuries
Time frame: Through study completion, an average of 1 year
Number of adverse events and injuries reported in user-testing arm.
Participant satisfaction with toolkit, as assessed using a toolkit satisfaction scale
Time frame: Within 1 week after user-testing period
Investigator developed multi-item satisfaction scale will include Likert-scaled items pertaining to satisfaction with design and delivery of the toolkit among participants in the user-testing arm; item ranges 1=not satisfied at all to 5 very satisfied). Scores will be averaged to yield and overall satisfaction score with higher scores indicating a greater degree of satisfaction.
Participant perceived benefit with toolkit, as assessed using a toolkit benefit scale
Time frame: Within 1 week after user-testing period
Investigator developed multi-item benefit scale will include Likert-scaled items pertaining to perceived benefit from the toolkit among participants in the user-testing arm; item ranges 1=not beneficial at all to 5 very beneficial). Scores will be averaged to yield and overall benefit score with higher scores indicating a greater degree of benefit.
8 secondary outcomes
Percentage of participant completion of neuropsychiatric symptoms of dementia outcome measure, as assessed using the Neuropsychiatric Inventory-Questionnaire
Time frame: Baseline, pre user-testing period
Percentage of participant completion of neuropsychiatric symptoms of dementia outcome measure, as assessed using the Neuropsychiatric Inventory-Questionnaire
Time frame: Within 1 week after user-testing period
Percentage of participant completion of caregiver stress outcome measure, as assessed using the Perceived Stress Scale
Time frame: Baseline, pre user-testing period
Percentage of participant completion of caregiver stress outcome measure, as assessed using the Perceived Stress Scale
Time frame: Within 1 week after user-testing period
Percentage of participant completion of dyadic relationship strain outcome measure, as assessed using the Dyadic Relationship Scale
Time frame: Baseline, pre user-testing period
Percentage of participant completion of dyadic relationship strain outcome measure, as assessed using the Dyadic Relationship Scale
Time frame: Within 1 week after user-testing period
Percentage of participant completion of physiologic stress outcome measure, as assessed through salivary cortisol biospecimens
Time frame: Baseline, pre user-testing period
Percentage of participant completion of physiologic stress outcome measure, as assessed through salivary cortisol biospecimens
Time frame: Within 1 week after user-testing period
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 7 Mar 2025.
- Derived from this study: PubMed 36399169Harris M, Van Houtven C, Hastings S. Development of a Home-Based Stress Management Toolkit for Dementia Caring Dyads: Protocol for a Pilot Intervention Development and Feasibility Study. JMIR Res Protoc. 2022 Dec 14;11(12):e43098. doi: 10.2196/43098.
- 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.
Melissa L Harris, PhD principal investigator
Duke University School of Nursing
Susan N Hastings, 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 Early Phase 1 study testing Stress Management Toolkit in people with Dementia and Stress, 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 6 inclusion and 11 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 7 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 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Frequency of toolkit use (time frame: End of week 1 of user-testing period). The study lists 7 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 NCT05465551, 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 7 Mar 2025.