UveitisNCT04148365
Medication Compliance in the Paediatric Uveitis Population Reported by the Patients and Parents
An observational study of Uveitis, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Little is known about eye drop regime adherence in the paediatric population. In particular, no previous research has investigated this in the paediatric uveitis population, a group who can require doses up to six times daily, and at frequencies that change month to month. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Uveitis
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2020to 30 May 2021
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- Child, Adult
Study population: Paediatric uveitis population who attend Paediatric Ophthalmology Department Uveitis Clinic.
Who may be able to join
- Any child attending the Paediatric Ophthalmology Department Uveitis Clinic who is receiving eye drop treatment.
- Children with a diagnosis of uveitis receiving eye drop treatment between 0-18 years of age at the time of recruitment.
Who cannot join
- Children with follow up more than 3 months after the first meeting and consent will subsequently be excluded.
- At present the study does not have sufficient funding for translators. Potential participants that do not speak sufficient English to understand and respond to the questionnaire will be excluded. We hope to obtain additional funding following this preliminary research. A priority of any further work will be to provide translators and achieve a more inclusive approach.
- Children not accompanied by a person with parental responsibility will be excluded if they cannot provide their own consent.
Trial locations and contacts
1 site in 1 country.
About this study
Little is known about eye drop regime adherence in the paediatric population. In particular, no previous research has investigated this in the paediatric uveitis population, a group who can require doses up to six times daily, and at frequencies that change month to month. The aim of the study is to quantify the range of adherence to eye drop medication, and to investigate some of the reasons for non-compliance in a child specific study. By learning more about compliance, this will help create treatments that are better suited to children.
The study will recruit 50 children receiving eye drop treatment. After an interval of 1 week or more the children and their parents will be asked to complete a questionnaire about the frequency of the drops prescribed, and the frequency that they have used over the last interval. It will also ask questions about difficulties encountered administering the drops.
Read more
Changes in eye drop bottle weight will be measured during the interval and the result compared.
The information gathered from the questionnaires will be used to compare reports of adherence between the parent and child, the child's age and the bottle weight. The reasons reported for difficulties with adherence will also be reported. This is a preliminary investigatory study to identify whether an issue with medication non-adherence exists. The findings will be used to tailor further research into this area.
Read the detailed description
Purpose This study aims to provide new information about compliance with medications amongst children and adolescents in an outpatient Ophthalmic setting.
Previous studies have demonstrated in other conditions that adherence to eye drop regimes is extremely varied (50% to 90% of prescribed drops (Tan 2005)) in a range of paediatric conditions including myopia, amblyopia, herpes simplex keratitis, allergic conjunctivitis. There has not been any research into eye drop adherence in the paediatric uveitis population. Previous enquiries into quality of life in JIA have not included questions about drop adherence, frequency of flare ups or drop side effects (van Dijkhuizen 2018). Although this condition is not common, the prevalence of paediatric uveitis is 27.9 per 100,000 (Päivönsalo-Hietanen 2000), it has severe sight threatening complications despite modern treatment. The burden of disease can be substantial due to eye drops up to six times daily and weekly appointments during active episodes, as well as surveillance every 3-4 months in between flares.
There are certain issues that are specific to uveitis which require investigation. These include the high frequency of steroid drops, changes in frequency on a week by week basis, and the fact that it is an asymptomatic condition in the early stages. Other studies reporting drop adherence in the paediatric population are limited because definitions of adherence and its measurement is inconsistent, and often not the primary outcome of a study. Parents and clinicians have expressed concerns about how achievable very frequent dosing is. If a threshold above which eye drop adherence becomes very unreliable exists, for instance more than four times each day, then clinicans could adjust treatment regimes to reflect this. This may encourage clinicans to be able to confidently advocate moving on to alternative therapies, such as biological treatment rather than increasing drop frequency.
By measuring and understanding medication adherence in the paediatric and adolescent population helps design interventions to improve compliance and assess their success. Evidence of paediatric specific issues may also lead to the development of age adapted formulations or trial of existing products in novel ways, for instance slow release steroid inserts following paediatric cataract surgery (SY Lee 2002).
Design Treatment will not be impacted by the study. There is no randomisation. Compliance may be impacted by awareness of being involved in a study. This is a major limitation of the study.
However previous studies have been conducted investigating compliance and their finding have been held to be valid.
A effort has been made in the design of PIS to provide patients with information about the study while limiting the impression that their medication compliance is under scrutiny. Additional vague questions have been added to the questionnaire to obscure the focus of the questions.
- Conditions
- Uveitis
- Keywords
- Paediatrics
- Medical subject headings
- Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Paediatric Uveitis | Patients with Uveitis below the age of 18 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of reported medication errors (missed doses) among paediatric uveitis population.
to determine what level of compliance with eye drop regimes currently exists in the paediatric uveitis population.
Measured: 01/07/2020
Secondary outcomes (3)
What factors effect adherence to eye drop regimes? Including the frequency of eye drops and who administers the eye drops.
Idenifying factors affecting adherence to taking eye drops
Measured: 01/07/2020
Does the age of the child influence compliance?
What age is best compliant with eye drops
Measured: 01/07/2020
In children that are old enough to report drop use, is reported compliance comparable between child and parent?
Parent and child compliancy
Measured: 01/07/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start14 Feb 2020
- Primary completion30 Apr 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jane Ashworth, Principal investigator, Consultant Peadiatric Ophthalmologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148365
- Sponsor's protocol ID
- 257448
- Other IDs
- B00751
- Status last verified
- Aug 2021
- First submitted
- 30 Oct 2019
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Compliance in the Paediatric Uveitis Population Reported by the Patients and Parents
- ClinicalTrials.gov ID
- NCT04148365
- Acronym / sponsor ID
- 257448
- Conditions
- Uveitis
- Keywords
- Paediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 1 Nov 2019 (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.
Little is known about eye drop regime adherence in the paediatric population. In particular, no previous research has investigated this in the paediatric uveitis population, a group who can require doses up to six times daily, and at frequencies that change month to month. The aim of the study is to quantify the range of adherence to eye drop medication, and to investigate some of the reasons for non-compliance in a child specific study. By learning more about compliance, this will help create treatments that are better suited to children.
The study will recruit 50 children receiving eye drop treatment. After an interval of 1 week or more the children and their parents will be asked to complete a questionnaire about the frequency of the drops prescribed, and the frequency that they have used over the last interval. It will also ask questions about difficulties encountered administering the drops.
Changes in eye drop bottle weight will be measured during the interval and the result compared.
The information gathered from the questionnaires will be used to compare reports of adherence between the parent and child, the child's age and the bottle weight. The reasons reported for difficulties with adherence will also be reported. This is a preliminary investigatory study to identify whether an issue with medication non-adherence exists. The findings will be used to tailor further research into this area.
Detailed description
Purpose This study aims to provide new information about compliance with medications amongst children and adolescents in an outpatient Ophthalmic setting.
Previous studies have demonstrated in other conditions that adherence to eye drop regimes is extremely varied (50% to 90% of prescribed drops (Tan 2005)) in a range of paediatric conditions including myopia, amblyopia, herpes simplex keratitis, allergic conjunctivitis. There has not been any research into eye drop adherence in the paediatric uveitis population. Previous enquiries into quality of life in JIA have not included questions about drop adherence, frequency of flare ups or drop side effects (van Dijkhuizen 2018). Although this condition is not common, the prevalence of paediatric uveitis is 27.9 per 100,000 (Päivönsalo-Hietanen 2000), it has severe sight threatening complications despite modern treatment. The burden of disease can be substantial due to eye drops up to six times daily and weekly appointments during active episodes, as well as surveillance every 3-4 months in between flares.
There are certain issues that are specific to uveitis which require investigation. These include the high frequency of steroid drops, changes in frequency on a week by week basis, and the fact that it is an asymptomatic condition in the early stages. Other studies reporting drop adherence in the paediatric population are limited because definitions of adherence and its measurement is inconsistent, and often not the primary outcome of a study. Parents and clinicians have expressed concerns about how achievable very frequent dosing is. If a threshold above which eye drop adherence becomes very unreliable exists, for instance more than four times each day, then clinicans could adjust treatment regimes to reflect this. This may encourage clinicans to be able to confidently advocate moving on to alternative therapies, such as biological treatment rather than increasing drop frequency.
By measuring and understanding medication adherence in the paediatric and adolescent population helps design interventions to improve compliance and assess their success. Evidence of paediatric specific issues may also lead to the development of age adapted formulations or trial of existing products in novel ways, for instance slow release steroid inserts following paediatric cataract surgery (SY Lee 2002).
Design Treatment will not be impacted by the study. There is no randomisation. Compliance may be impacted by awareness of being involved in a study. This is a major limitation of the study.
However previous studies have been conducted investigating compliance and their finding have been held to be valid.
A effort has been made in the design of PIS to provide patients with information about the study while limiting the impression that their medication compliance is under scrutiny. Additional vague questions have been added to the questionnaire to obscure the focus of the questions.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paediatric Uveitis | – | –Patients with Uveitis below the age of 18 years. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Paediatric uveitis population who attend Paediatric Ophthalmology Department Uveitis Clinic.
Key inclusion criteria (2 listed)
- Any child attending the Paediatric Ophthalmology Department Uveitis Clinic who is receiving eye drop treatment.
- Children with a diagnosis of uveitis receiving eye drop treatment between 0-18 years of age at the time of recruitment.
Key exclusion criteria (3 listed)
- Children with follow up more than 3 months after the first meeting and consent will subsequently be excluded.
- At present the study does not have sufficient funding for translators. Potential participants that do not speak sufficient English to understand and respond to the questionnaire will be excluded. We hope to obtain additional funding following this preliminary research. A priority of any further work will be to provide translators and achieve a more inclusive approach.
- Children not accompanied by a person with parental responsibility will be excluded if they cannot provide their own consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of reported medication errors (missed doses) among paediatric uveitis population.
Time frame: 01/07/2020
to determine what level of compliance with eye drop regimes currently exists in the paediatric uveitis population.
3 secondary outcomes
What factors effect adherence to eye drop regimes? Including the frequency of eye drops and who administers the eye drops.
Time frame: 01/07/2020
Does the age of the child influence compliance?
Time frame: 01/07/2020
In children that are old enough to report drop use, is reported compliance comparable between child and parent?
Time frame: 01/07/2020
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 11 Aug 2021.
- 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.
Jane Ashworth principal investigator
Consultant Peadiatric Ophthalmologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uveitis, run by Manchester University NHS Foundation Trust at 1 site 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 2 inclusion and 3 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 11 Aug 2021. 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 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?
Frequency of reported medication errors (missed doses) among paediatric uveitis population. (time frame: 01/07/2020). 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 11 Aug 2021; AzTrials last refreshed its copy on 6 Nov 2026.