Cystic FibrosisMUKADONCT05795673
Peer-supporting for Teenagers With Cystic Fibrosis in the Transition of Care From Paediatric to Adult Services
A study testing Peer support program (intervention phase) in people with Cystic Fibrosis, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
In patients with cystic fibrosis, a deterioration in lung function around age 18, the age of transfer from pediatrics to adult care services, has been observed. Transfer is only one step in a transition process from pediatric to adult care taking place from age 12 to 24. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Peer support program (intervention phase)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Sep 2023to 1 Sep 2026
- 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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patient affected by cystic fibrosis
- patient able to understand and read French
- patient from 15 to 19 years , in a process of transition on paediatric care to adult care
- with a follow-up on a paediatric Cystic Fibrosis Centers Competences (CRCM)
- did not participate in the Phase 1 co-construction workgroup
- affiliated to the social security system
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- having agreed to participate and signed the consent for an adult patient, or legal guardian having agreed to participate and signed the consent for a minor patient
- affected cystic fibrosis
- able to understand and read French
- young adult, 19 to 24 years old
- with a follow-up on the adult CRCM (transition completed)
- affiliated to the social security system
- have agreed to participate and signed the consent form
- did not participate in the Phase 1 co-construction workgroup
Who cannot join
- patient with transplant
- patient with cystic fibrosis transmembrane regulator-related disorders (CFTR RD) or Screen Positive Inconclusive Diagnosis (SPID) Cystic Fibrosis
- patient with a curator, tutor or under the protection of a conservator
- pregnant or breastfeeding patient
- Concerning the mentor/peer-supporter (post period):
- patient with transplant
Show all 9Show fewer
- patient with CFTR RD or SPID Cystic Fibrosis
- patient with a curator, tutor or under the protection of a conservator
- pregnant or breastfeeding patient
Trial locations and contacts
4 sites in 1 country.
France4 sites
CRCM Lyon pédiatrie - Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, 69500
Philippe REIX, Pr, 04.27.85.54.70 ext. +33, philippe.reix@chu-lyon.fr
CRCM Grenoble adulte - Hôpital Albert Michallon
Grenoble, 38000
Rébecca HAMIDFAR, MD, 04.76.76.75.93 ext. +33, RHamidfar@chu-grenoble.fr
CRCM Grenoble pédiatrie - Hôpital Albert Michallon
Grenoble, 38000
Catherine Llerena, MD, 04 76 76 72 19 ext. +33, CLlerena@chu-grenoble.fr
CRCM Lyon adulte - Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre-Bénite, 69495
Quitterie REYNAUD, MD, 04.78.86.15.54 ext. +33, quitterie.reynaud@chu-lyon.fr
About this study
Official title: Peer-supporting for Teenagers With Cystic Fibrosis in a Process of Transition of Care From Paediatric to Adult Services : a Mixed-method Pilot Study to Assess the Feasibility of the Peer-support Intervention
In patients with cystic fibrosis, a deterioration in lung function around age 18, the age of transfer from pediatrics to adult care services, has been observed. Transfer is only one step in a transition process from pediatric to adult care taking place from age 12 to 24. Adolescence is a period of identity construction during which the disease alters self-image and self-esteem, and a period of empowerment in the management of the disease involving a re-appropriation of it. During this period, coping strategies and psychosocial skills are important to face all the issues that the adolescent encounters. Interventions for youth with chronic illnesses rarely incorporate this dimension. Peer support or peer-mentoring is one avenue for developing these coping skills. Peer support encompasses mutual support between people who are coping or have coped with similar challenging life experiences. Individuals with similar experiences would represent more credible role models to stimulate positive change in their peers. The function of peer support are to provide emotional, experiential, informational support.The effect of peer support improves social integration, coping skills, sense of self-efficacy of the peers being helped. Promotion of healthy youth behaviors by youth is the most widely evaluated youth engagement strategy in the community health sector. Peer-assisted devices have been tested to improve medication adherence and health status with youth with juvenile arthritis, asthma, and liver transplant recipients. By sharing their experience of a successful transition, young adults with cystic fibrosis may be able to help their adolescent peers better understand this transition. Our hypothesis is that implementing peer support with adolescents with cystic fibrosis improves their sense of self-efficacy, a dimension of coping skills.To our knowledge, there are no research studies on peer support in cystic fibrosis in France or abroad. Patients are recognized as partners capable of sharing their experiential knowledge with patients with a similar disease.
But this raises questions about the recruitment, supervision, preparation for peer-help and the role of these patients; about the effects of their involvement for themselves (valorization, anxiety) and for their peers (re-assurance, feeling of personal effectiveness). This justifies conducting an exploratory study to assess the feasibility of a peer-support intervention for youth with cystic fibrosis.
- Conditions
- Cystic Fibrosis
- Being tested
- Peer support program (intervention phase)
- Keywords
- Cystic Fibrosis, Peer helping, Transition
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support program (intervention phase)Other
Implementation and Evaluation:
Intervention of mentor to provide peer support targeting psychosocial skills, coping and quality of life of adolescents with cystic fibrosis during the pediatric-adult transition The evaluation of the feasibility of the peer support program consists of assessing the effectiveness of its implementation in terms of its effect on the target audience, its acceptability to participants, and its implementation.
The mentor and the mentee will be in contact once a month for a minimum of 3 months and a maximum of 6 months by telephone.
The mentor will know the themes that the teenager would like to address in the context of peer support.
The mentee will complete the various questionnaires provided in the protocol to answer the primary and secondary endpoints.
| Study group | Role | What they receive |
|---|---|---|
| Group Peer support | Other | Intervention of mentor to provide peer support Receives: Other: Peer support program (intervention phase) |
| Group Control | No intervention | Usual practices of accompaniment of the pediatric-adult transition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 6 months
Change in Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 6 months. The CFQ-R includes 34 cystic fibrosis-specific quality of life items, scored on a 4-modality scale, and exploring 9 dimensions including perceived health, burden of treatment, self-image (and body image in particular), emotional state, and social interaction that are particularly impacted by the transition period. The responses allow us to establish a score on a scale of 0 to 100, the higher the score the better the quality of life.
Measured: Baseline ; at 6 months
Change from baseline Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 3 months
Change in Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 3 months. The CFQ-R includes 34 cystic fibrosis-specific quality of life items, scored on a 4-modality scale, and exploring 9 dimensions including perceived health, burden of treatment, self-image (and body image in particular), emotional state, and social interaction that are particularly impacted by the transition period. The responses allow us to establish a score on a scale of 0 to 100, the higher the score the better the quality of life.
Measured: Baseline ; at 3 months
Secondary outcomes (11)
Effect of peer support model during pediatric-adult transition, assessed in adolescents (comparison between sponsored adolescents and non-sponsored adolescents) on their sense of self-efficacy
Adolescents' sense of self-efficacy (Phase 2 primary endpoint), measured by the French version of the generic 10-item General Self-Efficacy Scale (GSE) rated on a 4-modality scale (not at all true, barely true, moderately true, totally true).
Measured: Measurement at inclusion, 3 months and 6 months
Effect of peer support model during pediatric-adult transition, assessed in adolescents (comparison between sponsored adolescents, included in post period, and non-sponsored adolescents, included in pre period) on management and therapeutic adherence
Management and therapeutic adherence, measured by a cystic fibrosis-specific adherence self-assessment questionnaire and focusing on the patient's perceived adherence to the respiratory (physical therapy and therapeutics), digestive and nutritional components of cystic fibrosis management. This Cystic Fibrosis Compliance questionnaire will be used in its French version. Indeed, it has already been translated according to a standard translation-re translation procedure by the same research study in a previous study (N° 2019-A01029-48, favorable opinion of the Ethic committee West IV - Nantes on 10/09/2019). This previous study is still in progress and will be published at the end of the study.
Measured: Measurement at inclusion, 3 months and 6 months
Effect of peer support model during the pediatric-adult transition, assessed in adolescents (comparison between sponsored adolescents, included in the post period, and non-sponsored adolescents, included in the pre period) on sense of social integration.
Sense of social integration, measured by the 5 items of the "social integration and support" dimension of the validated French version of the Health Education Impact Questionnaire (heiQ).
The items are: 22) If I need help, I have people I can count on; 28) I have enough friends to help me cope with my health problems;31) When I feel sick, my family and the people who take care of me understand what I am going through;35) In general, I feel that my friends and family look after me well;37) I have enough opportunities to talk about my health problems with people who understand me. Responses are rated on a 4-way agreement scale (strongly disagree, disagree, agree, strongly agree).
Measured: Measurement at inclusion, 3 months and 6 months
Fidelity of peer-assistance process in relation to what was planned (criteria collected in the "after" period only).
Fidelity of the peer-assistance process in relation to what was planned (criteria collected in the "after" period only):
Collection of implementation indicators (grid for collecting the number of contacts between sponsor and sponsored person, the modalities and the themes discussed during the contacts) and qualitative analysis of the content of the exchanges of practices between sponsors during the peer-assistance period.
Measured: From inclusion to the end of pair-aidance, up to 8 months
Experience (Experience, Satisfaction, Acceptability) of peer support among sponsored adolescents, sponsors, parents and accompanying professionals by individual interviews 1 to 2 months after the end of peer support (collected in the "after" period).
Perceived experience/other effects of peer support by the accompanying professionals, and in particular perceived effects of peer support on their clinical practice.
- Experience/other perceived effects of peer support by sponsored adolescents, sponsors, parents.
- Acceptability and satisfaction of peer support by the participants (sponsored adolescents, sponsors, parents and accompanying professionals): Satisfaction feedback and identification of factors influencing acceptability (participants' sociodemographic characteristics, patients' clinical characteristics, sponsors' previous experiences of supportive roles, status and experiences of accompanying professionals, characteristics of the CRCM).
The collection and analysis of these three criteria will be carried out by means of a qualitative study using individual semi-directed interviews (criteria collected in the "after" period only), the content of which will be developed in phase 1.
Measured: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the number of questionnaires collected
Feasibility will be validate if a minimum of 90 questionnaires is collected
Measured: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the estimation of recruitment capacity
Recruitment capacity will be validate if a minimum of 30 patients (15 during each period) is included
Measured: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the number of resources needed to implement the intervention - Number and profile of accompanying professionals involved
Collection of the profesionnel's profile implicated on the study
Measured: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the number of resources needed to implement the intervention - Number of exchanges and time needed for supervision and training
Tracking of exchange and the necessary time for training
Measured: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the number of resources needed to implement the intervention - Collection of material resources needed
Peer support constructed during the period 1
Measured: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the estimation of the potential effect of the intervention on the feeling of self-efficacy measured by the GSE
The generic 10-item GSE rated on a 4-modality scale (not at all true, barely true,moderately true, totally true).
The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy
Measured: From inclusion to the end of pair-aidance, up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Prospective quasi-experimental before-and-after multicenter study
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quitterie REYNAUD, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05795673
- Sponsor's protocol ID
- 69HCL21_1096
- Acronym
- MUKADO
- Status last verified
- Aug 2023
- First submitted
- 2 Feb 2023
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-supporting for Teenagers With Cystic Fibrosis in a Process of Transition of Care From Paediatric to Adult Services : a Mixed-method Pilot Study to Assess the Feasibility of the Peer-support Intervention
- ClinicalTrials.gov ID
- NCT05795673
- Acronym / sponsor ID
- MUKADO / 69HCL21_1096
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Peer helping, Transition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 3 Apr 2023 (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.
In patients with cystic fibrosis, a deterioration in lung function around age 18, the age of transfer from pediatrics to adult care services, has been observed. Transfer is only one step in a transition process from pediatric to adult care taking place from age 12 to 24. Adolescence is a period of identity construction during which the disease alters self-image and self-esteem, and a period of empowerment in the management of the disease involving a re-appropriation of it. During this period, coping strategies and psychosocial skills are important to face all the issues that the adolescent encounters. Interventions for youth with chronic illnesses rarely incorporate this dimension. Peer support or peer-mentoring is one avenue for developing these coping skills. Peer support encompasses mutual support between people who are coping or have coped with similar challenging life experiences. Individuals with similar experiences would represent more credible role models to stimulate positive change in their peers. The function of peer support are to provide emotional, experiential, informational support.The effect of peer support improves social integration, coping skills, sense of self-efficacy of the peers being helped. Promotion of healthy youth behaviors by youth is the most widely evaluated youth engagement strategy in the community health sector. Peer-assisted devices have been tested to improve medication adherence and health status with youth with juvenile arthritis, asthma, and liver transplant recipients. By sharing their experience of a successful transition, young adults with cystic fibrosis may be able to help their adolescent peers better understand this transition. Our hypothesis is that implementing peer support with adolescents with cystic fibrosis improves their sense of self-efficacy, a dimension of coping skills.To our knowledge, there are no research studies on peer support in cystic fibrosis in France or abroad. Patients are recognized as partners capable of sharing their experiential knowledge with patients with a similar disease.
But this raises questions about the recruitment, supervision, preparation for peer-help and the role of these patients; about the effects of their involvement for themselves (valorization, anxiety) and for their peers (re-assurance, feeling of personal effectiveness). This justifies conducting an exploratory study to assess the feasibility of a peer-support intervention for youth with cystic fibrosis.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective quasi-experimental before-and-after multicenter study
| Arm | Type | Receives |
|---|---|---|
| Group Peer support | Other | Other: Peer support program (intervention phase)Intervention of mentor to provide peer support |
| Group Control | No intervention | –Usual practices of accompaniment of the pediatric-adult transition |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- patient affected by cystic fibrosis
- patient able to understand and read French
- patient from 15 to 19 years , in a process of transition on paediatric care to adult care
- with a follow-up on a paediatric Cystic Fibrosis Centers Competences (CRCM)
- did not participate in the Phase 1 co-construction workgroup
Key exclusion criteria (9 listed)
- patient with transplant
- patient with cystic fibrosis transmembrane regulator-related disorders (CFTR RD) or Screen Positive Inconclusive Diagnosis (SPID) Cystic Fibrosis
- patient with a curator, tutor or under the protection of a conservator
- pregnant or breastfeeding patient
- patient with transplant
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 |
|---|---|---|
| Peer support program (intervention phase)Implementation and Evaluation: Intervention of mentor to provide peer support targeting psychosocial skills, coping and quality of life of adolescents with cystic fibrosis during the pediatric-adult transition The evaluation of the feasibility of the peer support program consists of assessing the effectiveness of its implementation in terms of its effect on the target audience, its acceptability to participants, and its implementation. The mentor and the mentee will be in contact once a month for a minimum of 3 months and a maximum of 6 months by telephone. The mentor will know the themes that the teenager would like to address in the context of peer support. The mentee will complete the various questionnaires provided in the protocol to answer the primary and secondary endpoints. | Other | Group Peer support |
Primary outcome
Change from baseline Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 6 months
Time frame: Baseline ; at 6 months
Change in Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 6 months. The CFQ-R includes 34 cystic fibrosis-specific quality of life items, scored on a 4-modality scale, and exploring 9 dimensions including perceived health, burden of treatment, self-image (and body image in particular), emotional state, and social interaction that are particularly impacted by the transition period. The responses allow us to establish a score on a scale of 0 to 100, the higher the score the better the quality of life.
Change from baseline Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 3 months
Time frame: Baseline ; at 3 months
Change in Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 3 months. The CFQ-R includes 34 cystic fibrosis-specific quality of life items, scored on a 4-modality scale, and exploring 9 dimensions including perceived health, burden of treatment, self-image (and body image in particular), emotional state, and social interaction that are particularly impacted by the transition period. The responses allow us to establish a score on a scale of 0 to 100, the higher the score the better the quality of life.
11 secondary outcomes
Effect of peer support model during pediatric-adult transition, assessed in adolescents (comparison between sponsored adolescents and non-sponsored adolescents) on their sense of self-efficacy
Time frame: Measurement at inclusion, 3 months and 6 months
Effect of peer support model during pediatric-adult transition, assessed in adolescents (comparison between sponsored adolescents, included in post period, and non-sponsored adolescents, included in pre period) on management and therapeutic adherence
Time frame: Measurement at inclusion, 3 months and 6 months
Effect of peer support model during the pediatric-adult transition, assessed in adolescents (comparison between sponsored adolescents, included in the post period, and non-sponsored adolescents, included in the pre period) on sense of social integration.
Time frame: Measurement at inclusion, 3 months and 6 months
Fidelity of peer-assistance process in relation to what was planned (criteria collected in the "after" period only).
Time frame: From inclusion to the end of pair-aidance, up to 8 months
Experience (Experience, Satisfaction, Acceptability) of peer support among sponsored adolescents, sponsors, parents and accompanying professionals by individual interviews 1 to 2 months after the end of peer support (collected in the "after" period).
Time frame: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the number of questionnaires collected
Time frame: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the estimation of recruitment capacity
Time frame: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the number of resources needed to implement the intervention - Number and profile of accompanying professionals involved
Time frame: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the number of resources needed to implement the intervention - Number of exchanges and time needed for supervision and training
Time frame: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the number of resources needed to implement the intervention - Collection of material resources needed
Time frame: From inclusion to the end of pair-aidance, up to 8 months
Feasibility assessed by the estimation of the potential effect of the intervention on the feeling of self-efficacy measured by the GSE
Time frame: From inclusion to the end of pair-aidance, up to 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
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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.
Quitterie REYNAUD, MD principal investigator
Hospices Civils de Lyon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support program (intervention phase) in people with Cystic Fibrosis, run by Hospices Civils de Lyon at 4 sites in France.
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 14 inclusion and 9 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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 Stéphanie POUPON-BOURDY (0472115416 ext. +33, stephanie.poupon-bourdy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Quality of life of adolescents in transition, measured by the French version of the Cystic Fibrosis Questionnaire - Revised (CFQ-R) at 6 months (time frame: Baseline ; at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2023.