Mental StressNCT03721848
Impact of a Health and Mental Health Promotion Intervention Among Jordanians and Syrians.
A study testing Healthy community clinic NCD+MH and Healthy community clinic NCD in people with Mental Stress and Hypertension, run by University of Illinois at Urbana-Champaign at 1 site in Jordan.
Trial summary
Given the heightened risk of NCDs and mental health issues, it is critical for Jordanians and Syrian refugees to have access to prevention based health services. To address this need, the following project seeks to examine the capacity of Primary Care Health Centers to provide preventive services to empower patients… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Stress, Hypertension, Diabetes
- What is being tested?
- Healthy community clinic NCD+MH and Healthy community clinic NCD
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteJordan
- Study dates
- 30 Apr 2017to 30 Apr 2019
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Exclusion criteria:
- Renal dysfunction: also known as renal insufficiency or renal failure; assessed by self-report
- Heart failure: also known as congestive heart disease or chronic heart failure; assessed by self-report
- Functional disability: defined as any long-term activity limitation due to disease or injury; assessed by self-report
- Liver dysfunction: also known as liver failure, acute or chronic; assessed by self-report
- Uncontrolled Resistant Hypertension: defined as blood pressure remaining above the threshold despite lifestyle modifications and concurrent use of at least three antihypertensive medications from different classes with one being a diuretic10-11assessed by self-report
- Pregnant women
- Uncontrolled Hypothyroidism * Pregnant women are excluded because it would be almost impossible to find any reduction in pregnant women weight and that will show a negative impact of HCC intervention on weight reduction. Therefore, inclusion of pregnant women could be a confounding factor to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Health Promotion Interventions on the Management and Secondary Prevention of Non-Communicable Diseases Among Jordanians and Syrians in Jordan.
Given the heightened risk of NCDs and mental health issues, it is critical for Jordanians and Syrian refugees to have access to prevention based health services. To address this need, the following project seeks to examine the capacity of Primary Care Health Centers to provide preventive services to empower patients to manage NCDs and potential mental health issues for those who are experiencing distress.
The primary research question in this evaluation study is:
Read more
Does prevention-based health and mental health services in primary health clinics improve health status of Jordanians and Syrian refugees?
This research proposal will consist of three study conditions examining:
- Condition 1: an existing NCD preventive intervention consisting of 24 sessions, which are 45 minutes covering diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies and smoking;
- Condition 2: The existing NCD preventive intervention with 4 added mental health awareness sessions covering traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma;
- Condition 3: Treatment as usual
A group randomized study will be conducted in three clinics with patients of the respective clinics. The clinics will be identified prior to the study based on similar demographics, service utilization and staff capacity. Once the three clinics are identified they will be selected to one of the three study conditions. This research will be conducted in collaboration with the University of Illinois (UIUC), AmeriCares, and the Royal Health Awareness Society (RHAS) of Jordan. AmeriCares will work as the operational humanitarian organization collaborating with and providing support to RHAS and UIUC. RHAS's healthy community clinic is a community-based health project launched in 2011 conducted with the Ministry of Health (MOH). The project aims to build the capacity of participating Health Centers to provide better preventative services to empower patients to manage their diseases and reduce future complications. The Healthy Community Clinic, established within existing MOH facilities, provides medical practitioners with the training and resources necessary to implement management and prevention-based care to patients in underserved communities.
- Conditions
- Mental Stress, Hypertension, Diabetes
- Being tested
- Healthy community clinic NCD+MH, Healthy community clinic NCD
- Medical subject headings
- Stress, Psychological, Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy community clinic NCD+MHBehavioural
NCD+MH Awareness Intervention Overview:
- Patients are assigned, at minimum, one health awareness lecture per month with a total of 28 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses. iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, Smoking, Emotional Wellness, Stress Relief and Positive Coping. iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures
Healthy community clinic NCDBehavioural
- Patients are assigned, at minimum, one health awareness lecture per month with a total of 24 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses. iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, and Smoking iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures
| Study group | Role | What they receive |
|---|---|---|
| Healthy Community Clinic: NCD+MH | Experimental | The arm of this study consists of a 28 session intervention, which are 45 minutes and meet 2-3 times a month providing health awareness on non-communicable diseases diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies; smoking; traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma. Receives: Behavioral: Healthy community clinic NCD+MH |
| Healthy Community Clinic: NCD | Active comparator | The arm of this study consists of a 24 session intervention, which are 45 minutes and meet 2 times a month providing health awareness on non-communicable disease diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies; smoking. Receives: Behavioral: Healthy community clinic NCD |
| Treatment as usual | No intervention | This is treatment as usual where there is no intervention, but patients attend the clinic for treatment of non-communicable diseases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Behavior-Fruit Intake frequency (Assessing Change)
Likert 5 point question assessing frequency of fruit intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.
Measured: Baseline, Six Months, 12 Months, 18 months
Health Behavior-Vegetable Intake (Assessing Change)
Likert 5 point question assessing frequency of vegetable intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.
Measured: Baseline, Six Months, 12 Months, 18 months
Health Behavior-Bread Intake (Assessing Change)
Likert 5 point question assessing frequency of bread intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.
Measured: Baseline, Six Months, 12 Months, 18 months
Incidence of Smoking (Assessing Change)
Yes/no question asking participants if they smoke. If they answer yet to smoking they are prompted to ask how many cigarettes per week.
Measured: Baseline, Six Months, 12 Months, 18 months
Health Behavior- Level of Physical Activity (Assessing Change)
Question inquiring how much physical activity participants get per week. Likert question Ranging from a. 30 minutes b.30 min to 1 hour c. 1-2 hours, d. 2-5 hours, e. more than 5 hours
Measured: Baseline, Six Months, 12 Months, 18 months
Health Behavior-Amount of Red Meat Intake (Assessing Change)
Likert 5 point question assessing frequency of red meat intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.
Measured: Baseline, Six Months, 12 Months, 18 months
Secondary outcomes (9)
Duke Health Profile (Assessing Change)
Duke Health Profile: 17-item standardized self-report instrument containing six health measures (physical, mental, social, general, perceived health, and self-esteem), and four dysfunction measures (anxiety, depression, pain, and disability).
Measured: Baseline, Six Months, 12 Months, 18 months
Blood Pressure (Assessing Change)
Trained nurses will collect Blood Pressure: Patients will be asked to remain seated with their legs uncrossed for at least 5 minutes before blood pressure measurements can be taken. In a seated position, systolic and diastolic blood pressure will be measured in mmHg by sphygmomanometer. This measurement should be repeated three times and the average of the second and third measurements should be calculated for data analysis.
Measured: Baseline, Six Months, 12 Months, 18 months
BMI (Assessing Change)
Patients should be asked to remove their shoes and any outer garments, while maintaining cultural respect. Calibrated scales will be used to measure body weight to the nearest 0.5 kg. Height will be measured to the nearest 0.1 cm using the height rod attached to the scale.23The BMI will be calculated by dividing the mass in Kg over the square of the height in meters according to the equation below:
BMI = Mass (kg)/Height (m2)
Measured: Baseline, Six Months, 12 Months, 18 months
Laboratory tests: fasting blood glucose (Assessing Change)
Appointments for laboratory tests will occur in the mornings to allow for patients to fast overnight (a minimum of 8 hours). MedLabs phlebotomists will collect the samples. The amount of blood to be collected is 3 ml. Each tube is clearly marked with the volume of blood to be collected. Any specimen not meeting the test requirement in terms of volume must be rejected.
Measured: Baseline, Six Months, 12 Months, 18 months
Laboratory tests: HbA1c (Assessing Change)
Appointments for laboratory tests will occur in the mornings to allow for patients to fast overnight (a minimum of 8 hours). MedLabs phlebotomists will collect the samples. The amount of blood to be collected is 3 ml. Each tube is clearly marked with the volume of blood to be collected. Any specimen not meeting the test requirement in terms of volume must be rejected.
Measured: Baseline, Six Months, 12 Months, 18 months
Laboratory tests: total cholesterol (Assessing Change)
Appointments for laboratory tests will occur in the mornings to allow for patients to fast overnight (a minimum of 8 hours). The amount of blood to be collected is 3 ml. Each tube is clearly marked with the volume of blood to be collected. Any specimen not meeting the test requirement in terms of volume must be rejected.
Measured: Baseline, Six Months, 12 Months, 18 months
Health Behavior (Hypertension, Diabetes, Mental health, Nutrition) Knowledge Survey (Assessing Change)
22 item questionnaire developed to measure knowledge of risk and management of: hypertension, diabetes, mental health, nutrition. Participant can report yes/no/I don't know to each question. The correct items will then be summed to identify the levels of knowledge change across time.
Measured: Baseline, Six Months, 12 Months, 18 months
Brief Trauma Questionnaire (Assessing Change)
Brief Trauma Questionnaire:
The BTQ is a 10 item self-report questionnaire derived from the Brief Trauma Interview.
Measured: Baseline, Six Months, 12 Months, 18 months
Primary Care PTSD (Assessing Change)
Six item screen derived from the PTSD Checklist-Civilian Version to help primary care settings screen for persons with possible PTSD symptoms. The five point Likert Scale ranges from not at all to extremely inquiring on prevalence of PTSD symptoms (e.g. had repeated disturbing memories about an event; c) Avoided activities or situations because they reminded you of a stressful experience)
Measured: Baseline, Six Months, 12 Months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start30 Apr 2017
- Primary completion30 Jul 2017
- Study completion30 Apr 2019
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 Mental StressStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- * Condition 1: an existing NCD preventive intervention consisting of 24 sessions, which are 45 minutes covering diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies and smoking; * Condition 2: The existing NCD preventive intervention with 4 added mental health awareness sessions covering traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma; * Condition 3: Treatment as usual
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Americares, Royal Health Awareness Society
- Responsible party
- Principal investigator, Tara Powell, University of Illinois at Urbana-Champaign
- Investigators
- Tara Powell, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721848
- Sponsor's protocol ID
- 17390
- Status last verified
- Aug 2019
- First submitted
- 21 Aug 2018
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Powell TM, Shin OJ, Li SJ, Hsiao Y. Post-traumatic stress, social, and physical health: A mediation and moderation analysis of Syrian refugees and Jordanians in a border community. PLoS One. 2020 Oct 23;15(10):e0241036. doi: 10.1371/journal.pone.0241036. eCollection 2020.
PubMed 33095832
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Health Promotion Interventions on the Management and Secondary Prevention of Non-Communicable Diseases Among Jordanians and Syrians in Jordan.
- ClinicalTrials.gov ID
- NCT03721848
- Acronym / sponsor ID
- 17390
- Conditions
- Mental Stress, Hypertension, Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Americares, Royal Health Awareness Society
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 26 Oct 2018 (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.
Given the heightened risk of NCDs and mental health issues, it is critical for Jordanians and Syrian refugees to have access to prevention based health services. To address this need, the following project seeks to examine the capacity of Primary Care Health Centers to provide preventive services to empower patients to manage NCDs and potential mental health issues for those who are experiencing distress.
The primary research question in this evaluation study is:
Does prevention-based health and mental health services in primary health clinics improve health status of Jordanians and Syrian refugees?
This research proposal will consist of three study conditions examining:
- Condition 1: an existing NCD preventive intervention consisting of 24 sessions, which are 45 minutes covering diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies and smoking;
- Condition 2: The existing NCD preventive intervention with 4 added mental health awareness sessions covering traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma;
- Condition 3: Treatment as usual
A group randomized study will be conducted in three clinics with patients of the respective clinics. The clinics will be identified prior to the study based on similar demographics, service utilization and staff capacity. Once the three clinics are identified they will be selected to one of the three study conditions. This research will be conducted in collaboration with the University of Illinois (UIUC), AmeriCares, and the Royal Health Awareness Society (RHAS) of Jordan. AmeriCares will work as the operational humanitarian organization collaborating with and providing support to RHAS and UIUC. RHAS's healthy community clinic is a community-based health project launched in 2011 conducted with the Ministry of Health (MOH). The project aims to build the capacity of participating Health Centers to provide better preventative services to empower patients to manage their diseases and reduce future complications. The Healthy Community Clinic, established within existing MOH facilities, provides medical practitioners with the training and resources necessary to implement management and prevention-based care to patients in underserved communities.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- * Condition 1: an existing NCD preventive intervention consisting of 24 sessions, which are 45 minutes covering diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies and smoking; * Condition 2: The existing NCD preventive intervention with 4 added mental health awareness sessions covering traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma; * Condition 3: Treatment as usual
| Arm | Type | Receives |
|---|---|---|
| Healthy Community Clinic: NCD+MH | Experimental | Behavioral: Healthy community clinic NCD+MHThe arm of this study consists of a 28 session intervention, which are 45 minutes and meet 2-3 times a month providing health awareness on non-communicable diseases diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies; smoking; traumatic stress reactions, individual strategies for coping with stress and traumatic events and collective strategies for coping with stress and trauma. |
| Healthy Community Clinic: NCD | Active comparator | Behavioral: Healthy community clinic NCDThe arm of this study consists of a 24 session intervention, which are 45 minutes and meet 2 times a month providing health awareness on non-communicable disease diabetes, hypertension, obesity, reproductive health, cardiovascular diseases, allergies; smoking. |
| Treatment as usual | No intervention | –This is treatment as usual where there is no intervention, but patients attend the clinic for treatment of non-communicable diseases. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Exclusion criteria:
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 |
|---|---|---|
| Healthy community clinic NCD+MHNCD+MH Awareness Intervention Overview: i. Patients are assigned, at minimum, one health awareness lecture per month with a total of 28 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses. iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, Smoking, Emotional Wellness, Stress Relief and Positive Coping. iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures | Behavioural | Healthy Community Clinic: NCD+MH |
| Healthy community clinic NCDi. Patients are assigned, at minimum, one health awareness lecture per month with a total of 24 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses. iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, and Smoking iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures | Behavioural | Healthy Community Clinic: NCD |
Primary outcome
Health Behavior-Fruit Intake frequency (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Likert 5 point question assessing frequency of fruit intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.
Health Behavior-Vegetable Intake (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Likert 5 point question assessing frequency of vegetable intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.
Health Behavior-Bread Intake (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Likert 5 point question assessing frequency of bread intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.
Incidence of Smoking (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Yes/no question asking participants if they smoke. If they answer yet to smoking they are prompted to ask how many cigarettes per week.
Health Behavior- Level of Physical Activity (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Question inquiring how much physical activity participants get per week. Likert question Ranging from a. 30 minutes b.30 min to 1 hour c. 1-2 hours, d. 2-5 hours, e. more than 5 hours
Health Behavior-Amount of Red Meat Intake (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Likert 5 point question assessing frequency of red meat intake within a week (a. none, b. 1-2 times per week, c. 3-4 times per week, d. 5 + times per week.
9 secondary outcomes
Duke Health Profile (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Blood Pressure (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
BMI (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Laboratory tests: fasting blood glucose (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Laboratory tests: HbA1c (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Laboratory tests: total cholesterol (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Health Behavior (Hypertension, Diabetes, Mental health, Nutrition) Knowledge Survey (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Brief Trauma Questionnaire (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 months
Primary Care PTSD (Assessing Change)
Time frame: Baseline, Six Months, 12 Months, 18 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 26 Aug 2019.
- Derived from this study: PubMed 33095832Powell TM, Shin OJ, Li SJ, Hsiao Y. Post-traumatic stress, social, and physical health: A mediation and moderation analysis of Syrian refugees and Jordanians in a border community. PLoS One. 2020 Oct 23;15(10):e0241036. doi: 10.1371/journal.pone.0241036. eCollection 2020.
- 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.
Tara Powell, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy community clinic NCD+MH and Healthy community clinic NCD in people with Mental Stress and Hypertension, run by University of Illinois at Urbana-Champaign at 1 site in Jordan.
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 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2019. 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 Jordan. 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?
Health Behavior-Fruit Intake frequency (Assessing Change) (time frame: Baseline, Six Months, 12 Months, 18 months). 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 NCT03721848, 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 26 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.