Terminal IllnessNCT04678310
iLIVE Volunteer Study
An observational study of Terminal Illness, run by University of Liverpool at 1 site in United Kingdom.
Trial summary
The aim of this study is to develop and evaluate the implementation of an international volunteer training programme to support patients dying in the hospital setting and their families. It has the following objectives: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Terminal Illness
- What is being tested?
- Support from the hospital palliative and end of life care volunteer service (developed for this study).
- How many people
- 105 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 31 Dec 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The study population will be any patient who is admitted to a participating hospital, and who meets the inclusion criteria for the study. All patients will have an advanced, incurable illness from which they will not be cured, and will have been assessed by their clinical team as being in the last month of life.
Who may be able to join
- Patient is >18 years old;
- The patient has already been recruited to the iLIVE Cohort Study (fulfilling the eligibility criteria);
- The physician or clinical team estimates the patient's life expectancy to be one month or less, based on a modified version of the 'Surprise Question' "Would you be surprised if this patient would die within one month?"
- The physician or clinical team agrees that the patient is eligible for involvement of the hospital palliative care volunteer service.
Who cannot join
- Patient is <18 years old;
- The patient has not already been recruited to the iLIVE Cohort Study and does not fulfil the eligibility criteria;
- The physician or clinical team does not estimate the patient's life expectancy to be one month or less, based on a modified version of the 'Surprise Question' "Would you be surprised if this patient would die within one month?"
- The physician or clinical team do not agree that the patient is eligible for involvement of the hospital palliative care volunteer service.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool University Hospitals NHS Foundation Trust
Liverpool, L7 8XP
About this study
Official title: iLIVE Project: Live Well, Die Well. A Nested Volunteer Study
The aim of this study is to develop and evaluate the implementation of an international volunteer training programme to support patients dying in the hospital setting and their families. It has the following objectives:
- Explore the experience and perceptions of the international hospital palliative and end of life care volunteer programme, including care delivery, from the perspectives of:
- Patients and their family members who receive the service
- Volunteers who deliver the service
- Health care professionals caring for patients who receive the service
- Assess the implementation and impact of a hospital volunteer service for dying patients
Read the detailed description
An excess of 5 million people die in the EU each year, with 77% of deaths resulting from chronic disease and illness. Of these 4 million deaths, many people will have died in pain or symptomatic distress, died alone, and/or died without structured health or social care for the patient and/or their family. Volunteer support represents an important and necessary community resource to enhance the experience of living at the end of life, and dying, however, a Cochrane review in 2015 concluded: "research is needed on the impact of training and support for palliative care volunteers on patients, their families, volunteers and palliative care services". Palliative care volunteer services are relatively uncommon and empirical evidence of the usefulness of such services in the hospital setting remains scarce.
An EU H2020 funded study, iLIVE, will address this concern. The iLIVE Volunteer Study, one of 8 workpackages within the iLIVE project, has developed an international hospital palliative care volunteer training programme, to support the implementation of palliative care volunteer services within five hospitals in five countries. The study will evaluate the implementation, use and experience of the iLIVE Volunteer Service across the five countries, embedded within the current iLIVE Cohort Study (ClinicalTrials.giv reference number: NCT04271085).
Aim/Rationale:
The aim of this study is to develop and evaluate the implementation of an international volunteer training programme to support patients dying in the hospital setting and their families.
Objectives:
- Explore the experience and perceptions of the international hospital palliative and end of life care volunteer programme, including care delivery, from the perspectives of:
- Patients and their family members who receive the service
- Volunteers who deliver the service
- Health care professionals caring for patients who receive the service
- Assess the implementation and impact of a hospital volunteer service for dying patients
- Conditions
- Terminal Illness
- Being tested
- Support from the hospital palliative and end of life care volunteer service (developed for this study).
- Keywords
- Dying, Palliative Care, Volunteers, End-of-Life-Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Support from the hospital palliative and end of life care volunteer service (developed for this study).Other
Hospital palliative and end of life care volunteer service: a volunteer service to provide support to patients dying in the hospital and their families. The volunteer service has been designed to provide presence and companionship to dying patients at the end of life, and their families.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | A patient will be assessed as 'eligible' for participation in the iLIVE Volunteer Study if they have an advanced, incurable illness that is unlikely to be cured, and they have been assessed by their clinical team as being in the last month of life. If patients meet this criteria, they will be offered support from the hospital palliative and end of life care volunteer service (developed for this study). Patients who agree to support will be recruited to the 'Intervention Group'. Receives: Other: Support from the hospital palliative and end of life care volunteer service (developed for this study). | |
| Case Control Comparison Group | If a patient is 'eligible' to receive support from the hospital palliative and end of life care volunteer service (see 'Intervention Group'), but declines involvement, they will be approached for inclusion in the study, as part of the 'Case Control Comparison' group for comparative analysis to assess the 'impact' of the volunteer service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).
The EQ-5D-5L is made up of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on 5 levels, using a 1-digit number: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems and 5 = extreme problems. The digits for the 5 dimensions are then combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled '100 = The best health you can imagine' and '0 = The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: Baseline (recruitment)
Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).
The EQ-5D-5L is made up of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on 5 levels, using a 1-digit number: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems and 5 = extreme problems. The digits for the 5 dimensions are then combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled '100 = The best health you can imagine' and '0 = The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: Follow-up 1 (7 days [+/- 2 days] following support from volunteer service)
Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).
The EQ-5D-5L is made up of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on 5 levels, using a 1-digit number: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems and 5 = extreme problems. The digits for the 5 dimensions are then combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled '100 = The best health you can imagine' and '0 = The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: Follow-up 2 (1 month following recruitment)
Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).
ICECAP-SCM is a self-completion questionnaire developed to evaluate quality of life in palliative and supportive care.
The ICECAP-SCM comprises 7 attributes: Having a say; Being with people who care about you; Physical suffering; Emotional suffering; Dignity; Being supported; Being prepared. Each dimension is scored on 4 levels ranging from: 4 = full capability; 1 = no capability. Higher scores indicate a better outcome.
Measured: Baseline (recruitment)
Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).
ICECAP-SCM is a self-completion questionnaire developed to evaluate quality of life in palliative and supportive care.
The ICECAP-SCM comprises 7 attributes: Having a say; Being with people who care about you; Physical suffering; Emotional suffering; Dignity; Being supported; Being prepared. Each dimension is scored on 4 levels ranging from: 4 = full capability; 1 = no capability. Higher scores indicate a better outcome.
Measured: Follow-up 1 (7 days [+/- 2 days] following support from volunteer service)
Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).
ICECAP-SCM is a self-completion questionnaire developed to evaluate quality of life in palliative and supportive care.
The ICECAP-SCM comprises 7 attributes: Having a say; Being with people who care about you; Physical suffering; Emotional suffering; Dignity; Being supported; Being prepared. Each dimension is scored on 4 levels ranging from: 4 = full capability; 1 = no capability. Higher scores indicate a better outcome.
Measured: Follow-up 2 (1 month following recruitment)
Secondary outcomes (1)
Distress Thermometer (single measure questionnaire)
The Distress Thermometer is a one-item self-report screening tool for measuring psychological distress in cancer patients. The scale is measured from 0 - 10, where a higher number indicates a better outcome: 0 = No Distress and 10 = Extreme Distress.
Measured: Follow-up 1 (7 days [+/- 2 days] following support from volunteer service); follow-up 2 (1 month following recruitment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start1 Nov 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 Terminal IllnessStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- John E Ellershaw, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678310
- Sponsor's protocol ID
- UoL001538 iLIVE Volunteer
- Status last verified
- Jul 2023
- First submitted
- 8 Dec 2020
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yildiz B, van der Heide A, Bakan M, Iversen GS, Haugen DF, McGlinchey T, Smeding R, Ellershaw J, Fischer C, Simon J, Vibora-Martin E, Ruiz-Torreras I, Goossensen A; iLIVE consortium. Facilitators and barriers of implementing end-of-life care volunteering in a hospital in five European countries: the iLIVE study. BMC Palliat Care. 2024 Apr 2;23(1):88. doi: 10.1186/s12904-024-01423-5.
PubMed 38561727
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iLIVE Project: Live Well, Die Well. A Nested Volunteer Study
- ClinicalTrials.gov ID
- NCT04678310
- Acronym / sponsor ID
- UoL001538 iLIVE Volunteer
- Conditions
- Terminal Illness
- Keywords
- Dying, Palliative Care, Volunteers, End-of-Life-Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Dec 2020 (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 aim of this study is to develop and evaluate the implementation of an international volunteer training programme to support patients dying in the hospital setting and their families. It has the following objectives:
- Explore the experience and perceptions of the international hospital palliative and end of life care volunteer programme, including care delivery, from the perspectives of:
- Patients and their family members who receive the service
- Volunteers who deliver the service
- Health care professionals caring for patients who receive the service
- Assess the implementation and impact of a hospital volunteer service for dying patients
Detailed description
An excess of 5 million people die in the EU each year, with 77% of deaths resulting from chronic disease and illness. Of these 4 million deaths, many people will have died in pain or symptomatic distress, died alone, and/or died without structured health or social care for the patient and/or their family. Volunteer support represents an important and necessary community resource to enhance the experience of living at the end of life, and dying, however, a Cochrane review in 2015 concluded: "research is needed on the impact of training and support for palliative care volunteers on patients, their families, volunteers and palliative care services". Palliative care volunteer services are relatively uncommon and empirical evidence of the usefulness of such services in the hospital setting remains scarce.
An EU H2020 funded study, iLIVE, will address this concern. The iLIVE Volunteer Study, one of 8 workpackages within the iLIVE project, has developed an international hospital palliative care volunteer training programme, to support the implementation of palliative care volunteer services within five hospitals in five countries. The study will evaluate the implementation, use and experience of the iLIVE Volunteer Service across the five countries, embedded within the current iLIVE Cohort Study (ClinicalTrials.giv reference number: NCT04271085).
Aim/Rationale:
The aim of this study is to develop and evaluate the implementation of an international volunteer training programme to support patients dying in the hospital setting and their families.
Objectives:
- Explore the experience and perceptions of the international hospital palliative and end of life care volunteer programme, including care delivery, from the perspectives of:
- Patients and their family members who receive the service
- Volunteers who deliver the service
- Health care professionals caring for patients who receive the service
- Assess the implementation and impact of a hospital volunteer service for dying patients
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Other: Support from the hospital palliative and end of life care volunteer service (developed for this study).A patient will be assessed as 'eligible' for participation in the iLIVE Volunteer Study if they have an advanced, incurable illness that is unlikely to be cured, and they have been assessed by their clinical team as being in the last month of life. If patients meet this criteria, they will be offered support from the hospital palliative and end of life care volunteer service (developed for this study). Patients who agree to support will be recruited to the 'Intervention Group'. |
| Case Control Comparison Group | – | –If a patient is 'eligible' to receive support from the hospital palliative and end of life care volunteer service (see 'Intervention Group'), but declines involvement, they will be approached for inclusion in the study, as part of the 'Case Control Comparison' group for comparative analysis to assess the 'impact' of the volunteer service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will be any patient who is admitted to a participating hospital, and who meets the inclusion criteria for the study. All patients will have an advanced, incurable illness from which they will not be cured, and will have been assessed by their clinical team as being in the last month of life.
Key inclusion criteria (4 listed)
- Patient is >18 years old;
- The patient has already been recruited to the iLIVE Cohort Study (fulfilling the eligibility criteria);
- The physician or clinical team estimates the patient's life expectancy to be one month or less, based on a modified version of the 'Surprise Question' "Would you be surprised if this patient would die within one month?"
- The physician or clinical team agrees that the patient is eligible for involvement of the hospital palliative care volunteer service.
Key exclusion criteria (4 listed)
- Patient is <18 years old;
- The patient has not already been recruited to the iLIVE Cohort Study and does not fulfil the eligibility criteria;
- The physician or clinical team does not estimate the patient's life expectancy to be one month or less, based on a modified version of the 'Surprise Question' "Would you be surprised if this patient would die within one month?"
- The physician or clinical team do not agree that the patient is eligible for involvement of the hospital palliative care volunteer service.
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 |
|---|---|---|
| Support from the hospital palliative and end of life care volunteer service (developed for this study).Hospital palliative and end of life care volunteer service: a volunteer service to provide support to patients dying in the hospital and their families. The volunteer service has been designed to provide presence and companionship to dying patients at the end of life, and their families. | Other | Intervention Group |
Primary outcome
Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).
Time frame: Baseline (recruitment)
The EQ-5D-5L is made up of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on 5 levels, using a 1-digit number: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems and 5 = extreme problems. The digits for the 5 dimensions are then combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled '100 = The best health you can imagine' and '0 = The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).
Time frame: Follow-up 1 (7 days [+/- 2 days] following support from volunteer service)
The EQ-5D-5L is made up of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on 5 levels, using a 1-digit number: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems and 5 = extreme problems. The digits for the 5 dimensions are then combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled '100 = The best health you can imagine' and '0 = The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L).
Time frame: Follow-up 2 (1 month following recruitment)
The EQ-5D-5L is made up of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on 5 levels, using a 1-digit number: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems and 5 = extreme problems. The digits for the 5 dimensions are then combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled '100 = The best health you can imagine' and '0 = The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).
Time frame: Baseline (recruitment)
ICECAP-SCM is a self-completion questionnaire developed to evaluate quality of life in palliative and supportive care. The ICECAP-SCM comprises 7 attributes: Having a say; Being with people who care about you; Physical suffering; Emotional suffering; Dignity; Being supported; Being prepared. Each dimension is scored on 4 levels ranging from: 4 = full capability; 1 = no capability. Higher scores indicate a better outcome.
Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).
Time frame: Follow-up 1 (7 days [+/- 2 days] following support from volunteer service)
ICECAP-SCM is a self-completion questionnaire developed to evaluate quality of life in palliative and supportive care. The ICECAP-SCM comprises 7 attributes: Having a say; Being with people who care about you; Physical suffering; Emotional suffering; Dignity; Being supported; Being prepared. Each dimension is scored on 4 levels ranging from: 4 = full capability; 1 = no capability. Higher scores indicate a better outcome.
Assessment of change over time, using the Patient Capability Measure: ICECAP Supportive Care Measure (ICECAP-SCM).
Time frame: Follow-up 2 (1 month following recruitment)
ICECAP-SCM is a self-completion questionnaire developed to evaluate quality of life in palliative and supportive care. The ICECAP-SCM comprises 7 attributes: Having a say; Being with people who care about you; Physical suffering; Emotional suffering; Dignity; Being supported; Being prepared. Each dimension is scored on 4 levels ranging from: 4 = full capability; 1 = no capability. Higher scores indicate a better outcome.
1 secondary outcome
Distress Thermometer (single measure questionnaire)
Time frame: Follow-up 1 (7 days [+/- 2 days] following support from volunteer service); follow-up 2 (1 month following recruitment)
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 28 Feb 2024.
- Derived from this study: PubMed 38561727Yildiz B, van der Heide A, Bakan M, Iversen GS, Haugen DF, McGlinchey T, Smeding R, Ellershaw J, Fischer C, Simon J, Vibora-Martin E, Ruiz-Torreras I, Goossensen A; iLIVE consortium. Facilitators and barriers of implementing end-of-life care volunteering in a hospital in five European countries: the iLIVE study. BMC Palliat Care. 2024 Apr 2;23(1):88. doi: 10.1186/s12904-024-01423-5.
- 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.
John E Ellershaw principal investigator
University of Liverpool
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Terminal Illness, run by University of Liverpool at 1 site in United Kingdom.
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 4 inclusion and 4 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 28 Feb 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 Kingdom. 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?
Assessment of change over time, using the EuroQol Group 5-level EQ-5D version questionnaire (EQ-5D-5L). (time frame: Baseline (recruitment)). The study lists 6 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 NCT04678310, 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 28 Feb 2024; AzTrials last refreshed its copy on 27 Oct 2026.