Health BehaviorNCT03705221
Healthy Parent Carers Feasibility Study
A study testing Healthy Parent Carers group programme and Healthy Parent Carers online resources in people with Health Behavior, run by University of Exeter at 6 sites in United Kingdom.
Trial summary
This study is a feasibility study of a peer-led group-based health promotion intervention for parent carers. It will used a parallel group randomised controlled trial design to compare a group based intervention called Healthy Parent Carers, with online resources about improving health and wellbeing. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- What is being tested?
- Healthy Parent Carers group programme and Healthy Parent Carers online resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 29 Oct 2018to 4 Feb 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- a) Primary carers of children who identify that their children have additional needs and/or disabilities. Participants who self-identify as primary carers are eligible. The child should be up to 25 years old (this age range is consistent with the current UK Department of Health and Department of Education Special Educational Needs \& Disability (SEND) legislation and The Children's Act);
- Willing and able to attend the programme group meeting session(s) on arranged dates/times;
- Able to access online information.
Who cannot join
- a) Not able to communicate in English.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Learn Devon Bideford
Bideford, Devon, EX39 2EY
Orchard Manor School
Dawlish, Devon, EX7 9SF
The Beach Hotel
Minehead, Somerset, TA24 5AP
Woodlands School
Plymouth, Devon, PL6 5ES
Children's Hospice South West Little Harbour
St Austell, Cornwall, PL26 6AZ
Torbay Parent Carer Forum
Torquay, Devon, TQ2 5QB
About this study
Official title: Healthy Parent Carers Programme: Feasibility Study of a Peer-led Group-based Health Promotion Intervention for Parent Carers of Disabled Children Using a Parallel Group Randomised Controlled Trial Design
This study is a feasibility study of a peer-led group-based health promotion intervention for parent carers. It will used a parallel group randomised controlled trial design to compare a group based intervention called Healthy Parent Carers, with online resources about improving health and wellbeing.
Read the detailed description
The objectives of the study are:
- to evaluate whether the programme can be delivered in the community, and
- to provide information necessary to design a definitive randomised controlled trial.
The investigators aim to recruit at least 96 parent carers of children with special educational needs and disabilities aged up to 25 years in six sites in Devon, Cornwall and Somerset. Participants will be individually randomised, stratified by group delivery site when recruitment in each site is completed, to either take part in a group programme, which includes online Healthy Parent Carer programme materials (intervention), or to receive access to the online materials for self-study only (control).
The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions. Groups will consist of at least 6 parent carers. The participant materials will be provided online.
Demographics will be collected at baseline. Participants will complete measures of mental health, wellbeing, health-related quality of life, health behaviours, patient activation, protective factors, and resource use. These data will be collected before randomisation (baseline), at post-intervention (i.e. after the intervention arm completes the group programme), and at 6 months post-intervention.
Recruitment will be monitored in order to plan for a definitive trial. Facilitators' adherence to the Facilitator Manual and participant engagement will be monitored using a facilitator checklist at the end of the sessions and we will audio-record the training sessions and group sessions. Participants' will provide feedback on the programme to assess the acceptability of the outcome measures. The investigators will conduct interviews with a sample of participants in both study arms and a focus group with facilitators to provide insights into intervention content, delivery and experience.
- Conditions
- Health Behavior
- Being tested
- Healthy Parent Carers group programme, Healthy Parent Carers online resources
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Parent Carers group programmeBehavioural
Peer-led group-based weekly programme.
Healthy Parent Carers online resourcesBehavioural
Online resources related to health and wellbeing
| Study group | Role | What they receive |
|---|---|---|
| Group programme | Experimental | Healthy Parent Carers group programme: A group-based peer led manualised programme called Healthy Parent Carers. The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions. Receives: Behavioral: Healthy Parent Carers group programme |
| Online resources | Active comparator | Healthy Parent Carers online resources: Online resources from the Healthy Parent Carers programme, including materials for 12 modules and related videos and audio files to illustrate the content. Receives: Behavioral: Healthy Parent Carers online resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Warwick-Edinburgh Mental Well-being Scale
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
Measured: 6 months post-intervention
Secondary outcomes (24)
Warwick-Edinburgh Mental Well-being Scale
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
Measured: Baseline
Warwick-Edinburgh Mental Well-being Scale
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
Measured: Immediately post-intervention (up to 12 weeks)
EQ-5D-5L
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life. It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
Measured: Baseline
EQ-5D-5L
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life. It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
Measured: Immediately post-intervention (up to 12 weeks)
EQ-5D-5L
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life. It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
Measured: 6 months post-intervention
PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
Measured: Baseline
PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
Measured: Immediately post-intervention (up to 12 weeks)
PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
Measured: 6 months post-intervention
Health Promoting Activities Scale
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
Measured: Baseline
Health Promoting Activities Scale
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
Measured: Immediately post-intervention (up to 12 weeks)
Health Promoting Activities Scale
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
Measured: 6 months post-intervention
Patient Activation Measure (PAM)
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
Measured: Baseline
Patient Activation Measure (PAM)
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
Measured: Immediately post-intervention (up to 12 weeks)
Patient Activation Measure (PAM)
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
Measured: 6 months post-intervention
Parents' Assessment of Protective Factors
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme. These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
Measured: Baseline
Parents' Assessment of Protective Factors
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme. These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
Measured: Immediately post-intervention (up to 12 weeks)
Parents' Assessment of Protective Factors
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme. These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
Measured: 6 months post-intervention
ICEpop CAPability measure for Adults (ICECAP-A)
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy. A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
Measured: Baseline
ICEpop CAPability measure for Adults (ICECAP-A)
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy. A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
Measured: Immediately post-intervention (up to 12 weeks)
ICEpop CAPability measure for Adults (ICECAP-A)
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy. A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
Measured: 6 months post-intervention
Service and Resource Use questionnaire
We will develop a resource use questionnaire in collaboration with parent carers. This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
Measured: Baseline
Service and Resource Use questionnaire
We will develop a resource use questionnaire in collaboration with parent carers. This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
Measured: Immediately post-intervention (up to 12 weeks)
Service and Resource Use questionnaire
We will develop a resource use questionnaire in collaboration with parent carers. This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
Measured: 6 months post-intervention
Programme Feedback Form
We will collect feedback from treatment and control arm participants about the Healthy Parent Carer materials and delivery via a feedback form. All participants will be asked to complete the feedback form at 15 weeks post-randomisation.
Measured: Immediately post-intervention (up to 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start29 Oct 2018
- Primary completion4 Feb 2020
- Study completion4 Feb 2020
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 Health BehaviorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Chris Morris, DPhil, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705221
- Sponsor's protocol ID
- NIHR RfPB PB-PG-0317-20044
- Other IDs
- 246169
- Status last verified
- Sep 2020
- First submitted
- 10 Oct 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Borek AJ, McDonald B, Fredlund M, Bjornstad G, Logan S, Morris C. Healthy Parent Carers programme: development and feasibility of a novel group-based health-promotion intervention. BMC Public Health. 2018 Feb 20;18(1):270. doi: 10.1186/s12889-018-5168-4.
PubMed 29458355Bjornstad G, Wilkinson K, Cuffe-Fuller B, Fitzpatrick K, Borek A, Ukoumunne OC, Hawton A, Tarrant M, Berry V, Lloyd J, McDonald A, Fredlund M, Rhodes S, Logan S, Morris C. Healthy Parent Carers peer-led group-based health promotion intervention for parent carers of disabled children: protocol for a feasibility study using a parallel group randomised controlled trial design. Pilot Feasibility Stud. 2019 Nov 23;5:137. doi: 10.1186/s40814-019-0517-3. eCollection 2019.
PubMed 31788323Bjornstad G, Cuffe-Fuller B, Ukoumunne OC, Fredlund M, McDonald A, Wilkinson K, Lloyd J, Hawton A, Berry V, Tarrant M, Borek A, Fitzpatrick K, Gillett A, Rhodes S, Logan S, Morris C. Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children. Pilot Feasibility Stud. 2021 Jul 23;7:144. doi: 10.1186/s40814-021-00881-5. eCollection 2021.
PubMed 34301334
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Parent Carers Programme: Feasibility Study of a Peer-led Group-based Health Promotion Intervention for Parent Carers of Disabled Children Using a Parallel Group Randomised Controlled Trial Design
- ClinicalTrials.gov ID
- NCT03705221
- Acronym / sponsor ID
- NIHR RfPB PB-PG-0317-20044
- Conditions
- Health Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 4 Feb 2020 (actual)
- First posted
- 15 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.
This study is a feasibility study of a peer-led group-based health promotion intervention for parent carers. It will used a parallel group randomised controlled trial design to compare a group based intervention called Healthy Parent Carers, with online resources about improving health and wellbeing.
Detailed description
The objectives of the study are:
- to evaluate whether the programme can be delivered in the community, and
- to provide information necessary to design a definitive randomised controlled trial.
The investigators aim to recruit at least 96 parent carers of children with special educational needs and disabilities aged up to 25 years in six sites in Devon, Cornwall and Somerset. Participants will be individually randomised, stratified by group delivery site when recruitment in each site is completed, to either take part in a group programme, which includes online Healthy Parent Carer programme materials (intervention), or to receive access to the online materials for self-study only (control).
The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions. Groups will consist of at least 6 parent carers. The participant materials will be provided online.
Demographics will be collected at baseline. Participants will complete measures of mental health, wellbeing, health-related quality of life, health behaviours, patient activation, protective factors, and resource use. These data will be collected before randomisation (baseline), at post-intervention (i.e. after the intervention arm completes the group programme), and at 6 months post-intervention.
Recruitment will be monitored in order to plan for a definitive trial. Facilitators' adherence to the Facilitator Manual and participant engagement will be monitored using a facilitator checklist at the end of the sessions and we will audio-record the training sessions and group sessions. Participants' will provide feedback on the programme to assess the acceptability of the outcome measures. The investigators will conduct interviews with a sample of participants in both study arms and a focus group with facilitators to provide insights into intervention content, delivery and experience.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group programme | Experimental | Behavioral: Healthy Parent Carers group programmeHealthy Parent Carers group programme: A group-based peer led manualised programme called Healthy Parent Carers. The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions. |
| Online resources | Active comparator | Behavioral: Healthy Parent Carers online resourcesHealthy Parent Carers online resources: Online resources from the Healthy Parent Carers programme, including materials for 12 modules and related videos and audio files to illustrate the content. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- a) Primary carers of children who identify that their children have additional needs and/or disabilities. Participants who self-identify as primary carers are eligible. The child should be up to 25 years old (this age range is consistent with the current UK Department of Health and Department of Education Special Educational Needs \& Disability (SEND) legislation and The Children's Act);
Key exclusion criteria (1 listed)
- a) Not able to communicate in English.
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 Parent Carers group programmePeer-led group-based weekly programme. | Behavioural | Group programme |
| Healthy Parent Carers online resourcesOnline resources related to health and wellbeing | Behavioural | Online resources |
Primary outcome
Warwick-Edinburgh Mental Well-being Scale
Time frame: 6 months post-intervention
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
24 secondary outcomes
Warwick-Edinburgh Mental Well-being Scale
Time frame: Baseline
Warwick-Edinburgh Mental Well-being Scale
Time frame: Immediately post-intervention (up to 12 weeks)
EQ-5D-5L
Time frame: Baseline
EQ-5D-5L
Time frame: Immediately post-intervention (up to 12 weeks)
EQ-5D-5L
Time frame: 6 months post-intervention
PHQ-9
Time frame: Baseline
PHQ-9
Time frame: Immediately post-intervention (up to 12 weeks)
PHQ-9
Time frame: 6 months post-intervention
Health Promoting Activities Scale
Time frame: Baseline
Health Promoting Activities Scale
Time frame: Immediately post-intervention (up to 12 weeks)
Health Promoting Activities Scale
Time frame: 6 months post-intervention
Patient Activation Measure (PAM)
Time frame: Baseline
Patient Activation Measure (PAM)
Time frame: Immediately post-intervention (up to 12 weeks)
Patient Activation Measure (PAM)
Time frame: 6 months post-intervention
Parents' Assessment of Protective Factors
Time frame: Baseline
Parents' Assessment of Protective Factors
Time frame: Immediately post-intervention (up to 12 weeks)
Parents' Assessment of Protective Factors
Time frame: 6 months post-intervention
ICEpop CAPability measure for Adults (ICECAP-A)
Time frame: Baseline
ICEpop CAPability measure for Adults (ICECAP-A)
Time frame: Immediately post-intervention (up to 12 weeks)
ICEpop CAPability measure for Adults (ICECAP-A)
Time frame: 6 months post-intervention
Service and Resource Use questionnaire
Time frame: Baseline
Service and Resource Use questionnaire
Time frame: Immediately post-intervention (up to 12 weeks)
Service and Resource Use questionnaire
Time frame: 6 months post-intervention
Programme Feedback Form
Time frame: Immediately post-intervention (up to 12 weeks)
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 16 Sep 2020.
- Background: PubMed 29458355Borek AJ, McDonald B, Fredlund M, Bjornstad G, Logan S, Morris C. Healthy Parent Carers programme: development and feasibility of a novel group-based health-promotion intervention. BMC Public Health. 2018 Feb 20;18(1):270. doi: 10.1186/s12889-018-5168-4.
- Background: PubMed 31788323Bjornstad G, Wilkinson K, Cuffe-Fuller B, Fitzpatrick K, Borek A, Ukoumunne OC, Hawton A, Tarrant M, Berry V, Lloyd J, McDonald A, Fredlund M, Rhodes S, Logan S, Morris C. Healthy Parent Carers peer-led group-based health promotion intervention for parent carers of disabled children: protocol for a feasibility study using a parallel group randomised controlled trial design. Pilot Feasibility Stud. 2019 Nov 23;5:137. doi: 10.1186/s40814-019-0517-3. eCollection 2019.
- Derived from this study: PubMed 34301334Bjornstad G, Cuffe-Fuller B, Ukoumunne OC, Fredlund M, McDonald A, Wilkinson K, Lloyd J, Hawton A, Berry V, Tarrant M, Borek A, Fitzpatrick K, Gillett A, Rhodes S, Logan S, Morris C. Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children. Pilot Feasibility Stud. 2021 Jul 23;7:144. doi: 10.1186/s40814-021-00881-5. eCollection 2021.
- Healthy Parent Carers study websiteLink provided by the sponsor.
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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.
Chris Morris, DPhil principal investigator
University of Exeter
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Parent Carers group programme and Healthy Parent Carers online resources in people with Health Behavior, run by University of Exeter at 6 sites 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 3 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Warwick-Edinburgh Mental Well-being Scale (time frame: 6 months post-intervention). 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 NCT03705221, 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 16 Sep 2020.