Medication Compliance in the Paediatric Uveitis Population Reported by the Patients and Parents

NCT04148365 | Completed

• 2 other identifiers: 257448B00751
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Uveitis

Keywords

Paediatrics

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  01/07/2020

• Does the age of the child influence compliance?

  01/07/2020

• In children that are old enough to report drop use, is reported compliance comparable between child and parent?

  01/07/2020

Study Arms (1)

Paediatric Uveitis

Patients with Uveitis below the age of 18 years.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Paediatric uveitis population who attend Paediatric Ophthalmology Department Uveitis Clinic.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

Manchester Royal Eye Hospital

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• Jane Ashworth

  Consultant Peadiatric Ophthalmologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: February 14, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 30, 2021
• Last Updated: August 11, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)