AsthmaNCT03315572
Pediatric Ease of Use ELLIPTA Items
An observational study of Asthma, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
A range of devices has been developed to administer inhaled therapy for asthma, including dry powder inhaler (DPI) devices. ELLIPTA is a DPI that is preloaded with a drug therapy to treat asthmatic subjects. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Interviewer administered version of ease of use items, Self-administered version of ease of use items and Caregiver version of ease of use items
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Oct 2017to 1 Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A convenience sample of pediatric subject and caregiver dyads consisting of pediatric asthmatic subjects aged 5 to 11 years currently using a maintenance inhaler and his or her caregiver will be included.
Who may be able to join
- Child inclusion criteria
- Be 5 to 11 years of age
- Have asthma
- Currently use a maintenance inhaler to treat their asthma
- Be willing and able to provide assent
- Be willing and able to participate in a 45-minute interview in English Caregiver inclusion criteria
Show all 10Show fewer
- Above 18+ years of age
- Be a caregiver (parent or legal guardian) of a pediatric subject with asthma that meets the criteria above
- Be willing and able to provide signed and dated informed consent and parental permission in English
- Be willing and able to participate in a 45-minute interview
Who cannot join
- Nil
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Raleigh, North Carolina, 27612
GSK Investigational Site
Southfield, Michigan, 48034
About this study
Official title: Qualitative Research to Support Ellipta Ease-of-Use Questions in Pediatric Patients With Asthma
A range of devices has been developed to administer inhaled therapy for asthma, including dry powder inhaler (DPI) devices. ELLIPTA is a DPI that is preloaded with a drug therapy to treat asthmatic subjects. The objective of this study is to revise ease of use items developed for adults to be appropriate for completion by pediatric subjects in future clinical trials and to evaluate the newly developed items in subjects with asthma aged 5 to 11 years and their caregivers. This is a cross-sectional, qualitative study that will involve pediatric subjects with asthma who are currently using an asthma maintenance inhaler and their caregivers. Two rounds of repetitive cognitive interviews will be conducted with 16 subjects in each interview set. Each interview will last approximately 45 minutes. Data provided by pediatric subjects and their caregivers during interview will be collected as field notes and audio recordings which will be transcribed.
- Conditions
- Asthma
- Being tested
- Interviewer administered version of ease of use items, Self-administered version of ease of use items, Caregiver version of ease of use items
- Keywords
- caregiver, ELLIPTA, Asthma, Dry Powder Inhaler, pediatric
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviewer administered version of ease of use itemsOther
The adult ease of use items will be modified to incorporate language appropriate for pediatric subjects. The interview will be administered by trained clinic-staff for subjects aged 5 to 7 years and those aged 8 to 11 years having difficulty in reading.
Self-administered version of ease of use itemsOther
The interview will be self-administered by subjects aged 8 to 11 years.
Caregiver version of ease of use itemsOther
Caregivers will be asked questions regarding their observations and experiences while their child was using ELLIPTA inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric subject/caregiver dyads-first interview set | The first interview set will consist of eight pediatric subject/caregiver dyads including pediatric subjects with asthma currently using a maintenance inhaler and his or her caregiver. The pediatric subjects and their caregivers will be asked questions regarding ease of use of ELLIPTA inhaler. Receives: Other: Interviewer administered version of ease of use items; Other: Self-administered version of ease of use items; Other: Caregiver version of ease of use items | |
| Pediatric subject/caregiver dyads-second interview set | The second interview set will consist of eight pediatric subject/caregiver dyads including pediatric subjects with asthma currently using a maintenance inhaler and his or her caregiver. The pediatric subjects and their caregivers will be asked questions regarding ease of use of ELLIPTA inhaler. Receives: Other: Interviewer administered version of ease of use items; Other: Self-administered version of ease of use items; Other: Caregiver version of ease of use items |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews
The items for pediatric participants were developed to assess the concepts of overall ease of use of ELLIPTA and ease of evaluating remaining doses in inhaler. Pediatric participants aged 5 to 7 years were required to complete the interviewer-administered version and participants aged 8 to 11 years were administered self-completed version. Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c) and one item to assess if the pediatric participants could compare different types of inhalers (Item 3). The number of participants who had problems in understanding the item wordings has been presented. No statistical analyses were conducted for this qualitative study.
Measured: Up to 45 minutes
Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews
Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c) and 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c). Three response options were developed for these two concepts: Item 1a/2a-a verbal response scale with four options (Very easy, easy, hard, very hard); Item 1b/2b-the same four verbal response options accompanied by illustrations of faces for each verbal response; and Item 1c/2c-a verbal response scale with two options (Yes, No). The number of participants who had difficulty in providing item responses has been presented.
Measured: Up to 45 minutes
Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews
Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c) and one item to understand if the participants could compare different types of inhalers. Three response options were developed to assess ease of inhaler use and ease of evaluating remaining doses: Item 1a/2a-a verbal response scale with four options (Very easy, easy, hard, very hard); Item 1b/2b-the same four verbal response options accompanied by illustrations of faces for each verbal response; and Item 1c/2c-a verbal response scale with two options (Yes, No). Item 3 consisted of 3 response options (Yes, No, The same). The number of participants who had difficulty in distinguishing item responses has been presented.
Measured: Up to 45 minutes
Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews
Round 1 of the interviews for caregiver participants evaluated the concepts of ease of evaluating remaining doses (Item 1) and the likelihood of requesting inhaler from their child's physician (Item 2). A response scale with four options was developed for each item: Item 1 (Very easy, Easy, Difficult, Very difficult) and Item 2 (Very likely, Likely, Unlikely, Very unlikely). The number of caregivers who had difficulty in providing responses to caregiver items has been reported.
Measured: Up to 45 minutes
Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews
Based on the results of Round 1 interviews, the four level verbal response scale (Item 1a and Item 2a) of the pediatric versions were selected for further evaluation of ease of use and ease in evaluating remaining doses in Round 2. The second set of interviews were conducted to test if any further revision is required to optimize the items. The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with problems understanding item wording has been presented.
Measured: Up to 45 minutes
Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews
The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with difficulty in providing response to items has been presented.
Measured: Up to 45 minutes
Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews
The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants who had difficulty in distinguishing between the response to items has been presented.
Measured: Up to 45 minutes
Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews
Based on the results of Round 1 interviews, both the items of caregiver version were retained for further evaluation in Round 2. The number of caregivers who had difficulty in providing responses to caregiver version of items has been presented below.
Measured: Up to 45 minutes
Number of Additional Ease of Use Items Identified
Caregivers were asked if there were any concepts regarding ease of use that were missing from the pediatric or caregiver versions according to them. The number of ease of use items as identified by caregiver participants has been presented.
Measured: Up to 45 minutes
Secondary outcomes (2)
Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle
At the end of cognitive debriefing of the items, the interviewers demonstrated how to use the ELLIPTA whistle and then the pediatric participants were provided with a whistle and asked to produce an audible sound. The number of pediatric participants who were able to produce an audible sound using the ELLIPTA whistle has been presented.
Measured: Up to 45 minutes
Number of Participants With Attempts Required to Produce an Audible Sound
At the end of cognitive debriefing of the items, the pediatric participants were asked to use the ELLIPTA whistle to produce an audible sound. The number of pediatric participants who required one to two attempts or more than three attempts to produce an audible sound has been presented.
Measured: Up to 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start17 Oct 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315572
- Sponsor's protocol ID
- 208129
- Other IDs
- HO-17-18594
- Status last verified
- Aug 2018
- First submitted
- 17 Oct 2017
- Last updated
- 28 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Halverson P, Liem J, Heyes L, Preece A, Bareille P, Rees J, Jain R, Stanford RH, Lenney W, Collison K, Sharma R. The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma. Pediatr Pulmonol. 2021 Jan;56(1):57-64. doi: 10.1002/ppul.25149. Epub 2020 Nov 19.
PubMed 33124762
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative Research to Support Ellipta Ease-of-Use Questions in Pediatric Patients With Asthma
- ClinicalTrials.gov ID
- NCT03315572
- Acronym / sponsor ID
- 208129
- Conditions
- Asthma
- Keywords
- caregiver, ELLIPTA, Asthma, Dry Powder Inhaler, pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Study start
- 17 Oct 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Posted 28 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A range of devices has been developed to administer inhaled therapy for asthma, including dry powder inhaler (DPI) devices. ELLIPTA is a DPI that is preloaded with a drug therapy to treat asthmatic subjects. The objective of this study is to revise ease of use items developed for adults to be appropriate for completion by pediatric subjects in future clinical trials and to evaluate the newly developed items in subjects with asthma aged 5 to 11 years and their caregivers. This is a cross-sectional, qualitative study that will involve pediatric subjects with asthma who are currently using an asthma maintenance inhaler and their caregivers. Two rounds of repetitive cognitive interviews will be conducted with 16 subjects in each interview set. Each interview will last approximately 45 minutes. Data provided by pediatric subjects and their caregivers during interview will be collected as field notes and audio recordings which will be transcribed.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric subject/caregiver dyads-first interview set | – | Other: Interviewer administered version of ease of use items, Other: Self-administered version of ease of use items, Other: Caregiver version of ease of use itemsThe first interview set will consist of eight pediatric subject/caregiver dyads including pediatric subjects with asthma currently using a maintenance inhaler and his or her caregiver. The pediatric subjects and their caregivers will be asked questions regarding ease of use of ELLIPTA inhaler. |
| Pediatric subject/caregiver dyads-second interview set | – | Other: Interviewer administered version of ease of use items, Other: Self-administered version of ease of use items, Other: Caregiver version of ease of use itemsThe second interview set will consist of eight pediatric subject/caregiver dyads including pediatric subjects with asthma currently using a maintenance inhaler and his or her caregiver. The pediatric subjects and their caregivers will be asked questions regarding ease of use of ELLIPTA inhaler. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A convenience sample of pediatric subject and caregiver dyads consisting of pediatric asthmatic subjects aged 5 to 11 years currently using a maintenance inhaler and his or her caregiver will be included.
Key inclusion criteria (10 listed)
- Child inclusion criteria
- Be 5 to 11 years of age
- Have asthma
- Currently use a maintenance inhaler to treat their asthma
- Be willing and able to provide assent
Key exclusion criteria (1 listed)
- Nil
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 |
|---|---|---|
| Interviewer administered version of ease of use itemsThe adult ease of use items will be modified to incorporate language appropriate for pediatric subjects. The interview will be administered by trained clinic-staff for subjects aged 5 to 7 years and those aged 8 to 11 years having difficulty in reading. | Other | Pediatric subject/caregiver dyads-first interview set, Pediatric subject/caregiver dyads-second interview set |
| Self-administered version of ease of use itemsThe interview will be self-administered by subjects aged 8 to 11 years. | Other | Pediatric subject/caregiver dyads-first interview set, Pediatric subject/caregiver dyads-second interview set |
| Caregiver version of ease of use itemsCaregivers will be asked questions regarding their observations and experiences while their child was using ELLIPTA inhaler. | Other | Pediatric subject/caregiver dyads-first interview set, Pediatric subject/caregiver dyads-second interview set |
Primary outcome
Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews
Time frame: Up to 45 minutes
The items for pediatric participants were developed to assess the concepts of overall ease of use of ELLIPTA and ease of evaluating remaining doses in inhaler. Pediatric participants aged 5 to 7 years were required to complete the interviewer-administered version and participants aged 8 to 11 years were administered self-completed version. Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c) and one item to assess if the pediatric participants could compare different types of inhalers (Item 3). The number of participants who had problems in understanding the item wordings has been presented. No statistical analyses were conducted for this qualitative study.
Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 1 Interviews
Time frame: Up to 45 minutes
Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c) and 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c). Three response options were developed for these two concepts: Item 1a/2a-a verbal response scale with four options (Very easy, easy, hard, very hard); Item 1b/2b-the same four verbal response options accompanied by illustrations of faces for each verbal response; and Item 1c/2c-a verbal response scale with two options (Yes, No). The number of participants who had difficulty in providing item responses has been presented.
Number of Pediatric Participants With Difficulty in Distinguishing Between the Item Responses-Round 1 Interviews
Time frame: Up to 45 minutes
Round 1 of the interviews evaluated 3 items to evaluate ease of use of inhaler (Items 1a, 1b and 1c), 3 items to assess the ease in evaluating remaining doses (Items 2a, 2b, 2c) and one item to understand if the participants could compare different types of inhalers. Three response options were developed to assess ease of inhaler use and ease of evaluating remaining doses: Item 1a/2a-a verbal response scale with four options (Very easy, easy, hard, very hard); Item 1b/2b-the same four verbal response options accompanied by illustrations of faces for each verbal response; and Item 1c/2c-a verbal response scale with two options (Yes, No). Item 3 consisted of 3 response options (Yes, No, The same). The number of participants who had difficulty in distinguishing item responses has been presented.
Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 1 Interviews
Time frame: Up to 45 minutes
Round 1 of the interviews for caregiver participants evaluated the concepts of ease of evaluating remaining doses (Item 1) and the likelihood of requesting inhaler from their child's physician (Item 2). A response scale with four options was developed for each item: Item 1 (Very easy, Easy, Difficult, Very difficult) and Item 2 (Very likely, Likely, Unlikely, Very unlikely). The number of caregivers who had difficulty in providing responses to caregiver items has been reported.
Number of Pediatric Participants With Problems Understanding Item Wording-Round 2 Interviews
Time frame: Up to 45 minutes
Based on the results of Round 1 interviews, the four level verbal response scale (Item 1a and Item 2a) of the pediatric versions were selected for further evaluation of ease of use and ease in evaluating remaining doses in Round 2. The second set of interviews were conducted to test if any further revision is required to optimize the items. The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with problems understanding item wording has been presented.
Number of Pediatric Participants With Difficulty Providing Responses to Items-Round 2 Interviews
Time frame: Up to 45 minutes
The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants with difficulty in providing response to items has been presented.
Number of Pediatric Participants With Difficulty in Distinguishing Between the Responses to Items-Round 2 Interviews
Time frame: Up to 45 minutes
The items for evaluation in Round 2 included: Item 1 and Item 2 for ease of ELLIPTA use and ease of evaluating remaining doses with a verbal scale of four options (Very easy, Easy, Hard, Very hard) and Item 3 for evaluation of the ability of participants to differentiate between inhalers consisting of three options (Yes, No, The same). The number of pediatric participants who had difficulty in distinguishing between the response to items has been presented.
Number of Caregiver Participants Who Had Difficulty Providing Responses to Caregiver Items-Round 2 Interviews
Time frame: Up to 45 minutes
Based on the results of Round 1 interviews, both the items of caregiver version were retained for further evaluation in Round 2. The number of caregivers who had difficulty in providing responses to caregiver version of items has been presented below.
Number of Additional Ease of Use Items Identified
Time frame: Up to 45 minutes
Caregivers were asked if there were any concepts regarding ease of use that were missing from the pediatric or caregiver versions according to them. The number of ease of use items as identified by caregiver participants has been presented.
2 secondary outcomes
Number of Pediatric Participants Who Were Able to Use ELLIPTA Whistle
Time frame: Up to 45 minutes
Number of Participants With Attempts Required to Produce an Audible Sound
Time frame: Up to 45 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33124762Halverson P, Liem J, Heyes L, Preece A, Bareille P, Rees J, Jain R, Stanford RH, Lenney W, Collison K, Sharma R. The evaluation of the correct use and ease-of use of the ELLIPTA DPI in children with asthma. Pediatr Pulmonol. 2021 Jan;56(1):57-64. doi: 10.1002/ppul.25149. Epub 2020 Nov 19.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline at 2 sites 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 10 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: finished, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Pediatric Participants With Problems Understanding Item Wording-Round 1 Interviews (time frame: Up to 45 minutes). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315572, 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 Jan 2019.