AsthmaPACKBrazilRNCT02786030
Integrated Primary Care for Chronic Lung Disease: PACK Brazil
A study testing Outreach education training and No outreach education training in people with Asthma and Chronic Obstructive Pulmonary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Outreach education training and No outreach education training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,950 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2017to 31 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic lower respiratory diseases (ICD10: J40-J47) recorded in electronic medical records since January 1st 2010
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Florianopolis City Health Department
Florianópolis, Santa Catarina, 88.040-400
Matheus Pacheco de Andrade, MD, +55 48 3239-1547, mpandrade.trabalho@gmail.com
Ronaldo Zonta, MD, +55 48 3239-1545, ronaldozonta@gmail.com
About this study
Official title: Integrated Primary Care for Chronic Lung Diseases in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit in Brazil (PACK Brazil)
This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of respiratory care and respiratory health outcomes, and comorbid conditions, in adults with asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 1250 patients known to have been diagnosed with asthma and 700 with COPD in participating clinics and will be included in the study. The primary endpoints for patients with asthma and COPD, respectively, will be composite scores indicating appropriate prescribing and diagnostic testing. The third primary endpoint, among all adult clinic users, will be rates of new diagnoses of asthma and COPD in each clinic. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate management of comorbid conditions such as cardiovascular risk factors. Eligible patients will be identified and outcomes measured using electronic medical records.
Read the detailed description
Long-lasting lung diseases like asthma and chronic obstructive lung disease (COPD) - collectively called chronic respiratory disease (CRD) - place a heavy and growing burden on people living in low and middle income countries. Many of them could be healthier if their disease was accurately diagnosed and correctly treated, but many are not. Doctors and nurses working in primary health care clinic are best placed people to diagnose and treat CRD, especially where local clinics are near and free. But this raises three questions: 1. How to ensure that CRDs get the priority they need in overloaded clinics? 2. How to train clinicians to diagnose and manage CRDs without special test equipment? 3. How to ensure rational evidence-based diagnosis and prescribing for CRD?
The investigators have developed a way of improving primary health care for people who have CRD, who often also have other long term health conditions. It is a patient management tool (PMT), that is, a printed manual of flowcharts taking doctors and nurses from symptoms to diagnoses to treatments, tests or referrals, with advice on how to make decisions along the way about diagnoses, tests, treatments and referrals. They are prompted to think of other diseases and health problems that might be undetected or neglected. The package also includes a method of training known as outreach education. First trainers are trained, then trainers train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions. The investigators' research in Africa has shown that this approach can be effective, cost effective, feasible and sustainable. It has been rolled out throughout South Africa and other African countries. But it has have not yet been shown to be effective for this combination of diseases (CRDs together with cardiovascular disease, diabetes, tuberculosis and back pain). The investigators have also not tried or evaluate it in Latin American countries, which have different health systems, and have many more doctors providing primary health care. Now co-investigators in the Brazilian city of Florianopolis have decided to put this educational package in place throughout the city, and have agreed to do so as a randomised controlled trial. This will clearly show whether PACK Brazil is effective, cost effective and feasible under Brazilian conditions.
The core of the research will be the randomised controlled trial. 48 primary care clinics in the city will be randomly chosen either 1) to get the whole package of patient management tool plus training, or 2) only to get the patient management tool (which we expect will make little difference without training). The investigators will compare patients in these two groups of clinics to see the effects of the training. They will use the clinics' electronic medical records to identify about 2000 adults diagnosed with asthma or COPD. After the training starts they will follow these patients up for a year, and assess whether they are being appropriately treated and tested. They will also compare the rates of new diagnoses of asthma and COPD in each clinic, and various health indicators.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Being tested
- Outreach education training, No outreach education training
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outreach education trainingBehavioural
Printed copies of the patient management tool (PMT) and outreach education training
No outreach education trainingBehavioural
Printed copies of the patient management tool (PMT) without outreach education training
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) and outreach education training. First trainers will be trained, then trainers will train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions. Receives: Behavioral: Outreach education training |
| Control | Active comparator | Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will not receive outreach education training. Receives: Behavioral: No outreach education training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma composite score
For participants with asthma the composite score will comprise points awarded for: i) a first prescription of an inhaled corticosteroid (ICS) or ICS+ long-acting bronchodilator (LABA) combination, or a change in prescription, stepping up from short acting bronchodilator (SABA) to ICS or from ICS to long acting bronchodilator(LABA)+ICS combination; or stepping down from LABA+ICS to ICS, or from ICS to SABA (scoring one point if at least one of these occurs); and ii) request for spirometry (one point). The composite score will be the sum of these points, and will thus range from 0-2. The composite scores for each patient for all visits during the year will be averaged.
Measured: During first year of follow-up
COPD composite score
For participants with COPD the composite score with comprise points awarded for: i) a first prescription of SABA, ICS, or ICS+LABA; or a change in prescription, stepping up from SABA to LABA or LABA to ICS+LABA, or stepping down from LABA+ICS to LABA, or from LABA to SABA (scoring one point if at least one of these occurs) and ii) request for spirometry (one point). The composite score will be the sum of these, and will thus also range from 0-2.
Measured: During first year of follow-up
Asthma-or-COPD diagnosis rate
Among all participants aged 18 years and over attending each clinic, the number of patients in whom either asthma or COPD is diagnosed for the first time
Measured: During first year of follow-up
Secondary outcomes (9)
Hospital admission rate for asthma
Hospital admission rate for asthma in each clinic
Measured: During first year of follow-up
Hospital admission rate for COPD
Hospital admission rate for COPD in each clinic
Measured: During first year of follow-up
Cardiovascular disease diagnoses
Number of patients with asthma or COPD in whom cardiovascular disease (ICD10 code I00-I99) is diagnosed for the first time
Measured: During first year of follow-up
Diabetes mellitus diagnosis
Number of patients with asthma or COPD in whom diabetes mellitus (ICD10 code E10-E14) is diagnosed for the first time
Measured: During first year of follow-up
Smoking cessation prescriptions
Number of participants in whom nicotine replacement therapy, nortryptiline, or bupropion are prescribed
Measured: During first year of follow-up
CVD risk assessment
Number of participants in whom blood pressure is recorded, or for whom cholesterol, glucose, or electrocardiogram tests are recorded
Measured: During first year of follow-up
Depression diagnosis
Number of participants in whom depression (ICD10 code F32-F34) is diagnosed for the first time
Measured: During first year of follow-up
Depression treatment
Number of participants in whom medication for depression (tricyclic and related antidepressants, selective serotonin re-uptake inhibitors, and monoamine oxidase inhibitors) is prescribed for the first time
Measured: During first year of follow-up
Death
Number of participants who died
Measured: During first year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study start1 Apr 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Santa Catarina Federal University, University of Cape Town, Federal University of Bahia, Medical Research Council, South Africa, University of East Anglia
- Responsible party
- Sponsor
- Investigators
- Max Bachmann, MBChB PhD, Principal investigator, University of East AngliaEric Bateman, MBChB MD, Principal investigator, University of Cape TownRafael Stelmach, MD PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786030
- Sponsor's protocol ID
- PACKBrazil1
- Acronym
- PACKBrazilR
- Status last verified
- Apr 2018
- First submitted
- 25 May 2016
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shekar S, Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Zonta R, Pacheco de Andrade M, Zepeda J, Cornick RV, Wattrus C, Georgeu-Pepper D, Anderson LF, Lombard C, Fairall LR. Effects of PACK training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians during 2 years of implementation in Florianopolis, Brazil: extended follow-up after a pragmatic cluster randomised controlled trial with a stepped-wedge design. BMJ Glob Health. 2024 Oct 28;9(Suppl 3):e013819. doi: 10.1136/bmjgh-2023-013819.
PubMed 39467591Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Pacheco de Andrade M, Zonta R, Zepeda J, Natal S, Cornick RV, Wattrus C, Anderson L, Georgeu-Pepper D, Lombard C, Fairall LR. Effects of PACK guide training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians: a pragmatic cluster randomised controlled trial in Florianopolis, Brazil. BMJ Glob Health. 2019 Dec 16;4(6):e001921. doi: 10.1136/bmjgh-2019-001921. eCollection 2019.
PubMed 31908865Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Pacheco de Andrade M, Zonta R, Zepeda J, Natal S, Cornick R, Wattrus C, Anderson L, Lombard C, Fairall LR. Integrating primary care of chronic respiratory disease, cardiovascular disease and diabetes in Brazil: Practical Approach to Care Kit (PACK Brazil): study protocol for randomised controlled trials. J Thorac Dis. 2018 Jul;10(7):4667-4677. doi: 10.21037/jtd.2018.07.34.
PubMed 30174920
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Primary Care for Chronic Lung Diseases in Less Developed Countries: Pragmatic Trial of the Practical Approach to Care Kit in Brazil (PACK Brazil)
- ClinicalTrials.gov ID
- NCT02786030
- Acronym / sponsor ID
- PACKBrazilR / PACKBrazil1
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,950 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Santa Catarina Federal University, University of Cape Town, Federal University of Bahia, Medical Research Council, South Africa, University of East Anglia
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 30 May 2016 (estimated)
- 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.
This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of respiratory care and respiratory health outcomes, and comorbid conditions, in adults with asthma and chronic obstructive pulmonary disease (COPD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 1250 patients known to have been diagnosed with asthma and 700 with COPD in participating clinics and will be included in the study. The primary endpoints for patients with asthma and COPD, respectively, will be composite scores indicating appropriate prescribing and diagnostic testing. The third primary endpoint, among all adult clinic users, will be rates of new diagnoses of asthma and COPD in each clinic. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate management of comorbid conditions such as cardiovascular risk factors. Eligible patients will be identified and outcomes measured using electronic medical records.
Detailed description
Long-lasting lung diseases like asthma and chronic obstructive lung disease (COPD) - collectively called chronic respiratory disease (CRD) - place a heavy and growing burden on people living in low and middle income countries. Many of them could be healthier if their disease was accurately diagnosed and correctly treated, but many are not. Doctors and nurses working in primary health care clinic are best placed people to diagnose and treat CRD, especially where local clinics are near and free. But this raises three questions: 1. How to ensure that CRDs get the priority they need in overloaded clinics? 2. How to train clinicians to diagnose and manage CRDs without special test equipment? 3. How to ensure rational evidence-based diagnosis and prescribing for CRD?
The investigators have developed a way of improving primary health care for people who have CRD, who often also have other long term health conditions. It is a patient management tool (PMT), that is, a printed manual of flowcharts taking doctors and nurses from symptoms to diagnoses to treatments, tests or referrals, with advice on how to make decisions along the way about diagnoses, tests, treatments and referrals. They are prompted to think of other diseases and health problems that might be undetected or neglected. The package also includes a method of training known as outreach education. First trainers are trained, then trainers train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions. The investigators' research in Africa has shown that this approach can be effective, cost effective, feasible and sustainable. It has been rolled out throughout South Africa and other African countries. But it has have not yet been shown to be effective for this combination of diseases (CRDs together with cardiovascular disease, diabetes, tuberculosis and back pain). The investigators have also not tried or evaluate it in Latin American countries, which have different health systems, and have many more doctors providing primary health care. Now co-investigators in the Brazilian city of Florianopolis have decided to put this educational package in place throughout the city, and have agreed to do so as a randomised controlled trial. This will clearly show whether PACK Brazil is effective, cost effective and feasible under Brazilian conditions.
The core of the research will be the randomised controlled trial. 48 primary care clinics in the city will be randomly chosen either 1) to get the whole package of patient management tool plus training, or 2) only to get the patient management tool (which we expect will make little difference without training). The investigators will compare patients in these two groups of clinics to see the effects of the training. They will use the clinics' electronic medical records to identify about 2000 adults diagnosed with asthma or COPD. After the training starts they will follow these patients up for a year, and assess whether they are being appropriately treated and tested. They will also compare the rates of new diagnoses of asthma and COPD in each clinic, and various health indicators.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Outreach education trainingDoctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) and outreach education training. First trainers will be trained, then trainers will train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions. |
| Control | Active comparator | Behavioral: No outreach education trainingDoctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will not receive outreach education training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of chronic lower respiratory diseases (ICD10: J40-J47) recorded in electronic medical records since January 1st 2010
Key exclusion criteria (1 listed)
- No 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 |
|---|---|---|
| Outreach education trainingPrinted copies of the patient management tool (PMT) and outreach education training | Behavioural | Intervention |
| No outreach education trainingPrinted copies of the patient management tool (PMT) without outreach education training | Behavioural | Control |
Primary outcome
Asthma composite score
Time frame: During first year of follow-up
For participants with asthma the composite score will comprise points awarded for: i) a first prescription of an inhaled corticosteroid (ICS) or ICS+ long-acting bronchodilator (LABA) combination, or a change in prescription, stepping up from short acting bronchodilator (SABA) to ICS or from ICS to long acting bronchodilator(LABA)+ICS combination; or stepping down from LABA+ICS to ICS, or from ICS to SABA (scoring one point if at least one of these occurs); and ii) request for spirometry (one point). The composite score will be the sum of these points, and will thus range from 0-2. The composite scores for each patient for all visits during the year will be averaged.
COPD composite score
Time frame: During first year of follow-up
For participants with COPD the composite score with comprise points awarded for: i) a first prescription of SABA, ICS, or ICS+LABA; or a change in prescription, stepping up from SABA to LABA or LABA to ICS+LABA, or stepping down from LABA+ICS to LABA, or from LABA to SABA (scoring one point if at least one of these occurs) and ii) request for spirometry (one point). The composite score will be the sum of these, and will thus also range from 0-2.
Asthma-or-COPD diagnosis rate
Time frame: During first year of follow-up
Among all participants aged 18 years and over attending each clinic, the number of patients in whom either asthma or COPD is diagnosed for the first time
9 secondary outcomes
Hospital admission rate for asthma
Time frame: During first year of follow-up
Hospital admission rate for COPD
Time frame: During first year of follow-up
Cardiovascular disease diagnoses
Time frame: During first year of follow-up
Diabetes mellitus diagnosis
Time frame: During first year of follow-up
Smoking cessation prescriptions
Time frame: During first year of follow-up
CVD risk assessment
Time frame: During first year of follow-up
Depression diagnosis
Time frame: During first year of follow-up
Depression treatment
Time frame: During first year of follow-up
Death
Time frame: During first year of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Derived from this study: PubMed 39467591Shekar S, Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Zonta R, Pacheco de Andrade M, Zepeda J, Cornick RV, Wattrus C, Georgeu-Pepper D, Anderson LF, Lombard C, Fairall LR. Effects of PACK training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians during 2 years of implementation in Florianopolis, Brazil: extended follow-up after a pragmatic cluster randomised controlled trial with a stepped-wedge design. BMJ Glob Health. 2024 Oct 28;9(Suppl 3):e013819. doi: 10.1136/bmjgh-2023-013819.
- Derived from this study: PubMed 31908865Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Pacheco de Andrade M, Zonta R, Zepeda J, Natal S, Cornick RV, Wattrus C, Anderson L, Georgeu-Pepper D, Lombard C, Fairall LR. Effects of PACK guide training on the management of asthma and chronic obstructive pulmonary disease by primary care clinicians: a pragmatic cluster randomised controlled trial in Florianopolis, Brazil. BMJ Glob Health. 2019 Dec 16;4(6):e001921. doi: 10.1136/bmjgh-2019-001921. eCollection 2019.
- Derived from this study: PubMed 30174920Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Pacheco de Andrade M, Zonta R, Zepeda J, Natal S, Cornick R, Wattrus C, Anderson L, Lombard C, Fairall LR. Integrating primary care of chronic respiratory disease, cardiovascular disease and diabetes in Brazil: Practical Approach to Care Kit (PACK Brazil): study protocol for randomised controlled trials. J Thorac Dis. 2018 Jul;10(7):4667-4677. doi: 10.21037/jtd.2018.07.34.
- 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.
Max Bachmann, MBChB PhD principal investigator
University of East Anglia
Eric Bateman, MBChB MD principal investigator
University of Cape Town
Rafael Stelmach, MD PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outreach education training and No outreach education training in people with Asthma and Chronic Obstructive Pulmonary Disease, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 27 Apr 2018. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matheus Andrade, MD (+55 48 3239-1547, mpandradetrabalho@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma composite score (time frame: During first year of follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02786030, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.