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NCT Number: NCT06070467

Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases

Rare Eye Diseases (RED) are the leading cause of severe visual impairment/ blindness (SVI/B) in children in Europe. This sensory disability with its accompanying psychological distress hugely impacts their lives and their families. Understanding this impact, at a patient centred level, is key in care, in shared decision making, in developing therapies, and in improving social integration and participation about the standard rules of the United Nations (UN) and the European Union (EU) (prevention, non-discrimination, equal opportunities, accessibility, etc.). However, current tools to evaluate vision related (VR) quality of life (QoL) VR-QoL disregard age and cultural differences. There is a lack knowledge on how the disease matters at child's level. Instruments capable of yielding high-quality data, psychometrically robust and comply with regulatory requirements remain to be developed.

To fill this gap, SeeMyLife will use multilevel concurrent mixed method research combining quantitative studies and qualitative studies. The quantitative approach is based on (i) cross culturally translated validated VR-QoL questionnaires for children and teenagers (Functional Vision Questionnaire for Children and Young People - FVQ-CYP and Vision-related Quality of Life Questionnaire for Children and Young People - VQoL-CYP) and (ii) on caregiver's questionnaires addressing participation and environment (Participation and Environment Measure - Children and Youth - PEM-CY). To fully capture the picture of the child/teenager personal life the investigators will reinforce their investigations by in depth qualitative socio-anthropologic study with semi directive field interviews and fieldwork (to observe closely the living conditions of the children) to address how their impairment affects their wellbeing, social integration, and how they feel about medical and social interventions. Data analysis will use an integrated mixed method strategy to validate the quantitative tools and deliver a holistic QoL transnational tool.

The SeeMyLife project will provide (i) robust patient self-reported tools that will be then used in care and research (especially with the rise in novel therapies) as a standard as well as (ii) highly awaited knowledge about the SVI/B patient's position within his own life course, within his family and in relation to health and social care actors.

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Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Référence pour les Affections Rares en Génétique Ophtalmologique (CARGO), Hôpitaux Universitaires

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Hélène DOLLFUS, MD

CONTACT

[email protected]

33.3.88.12.81.20

Hélène DOLLFUS, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children (age 8-12) and teenagers (age 13-18) with various levels of visual impairment defined according to World Health Organization (WHO) International Classification of Diseases (ICD) 10 - WHO ICD 10 [best-corrected visual acuity ≤ 0.3 decimal or ≤ 6/18], and their parents/caregivers.

Exclusion criteria

  • Children, teenagers, and caregivers:
  • who lack the ability to respond in a reliable way to the questions on how they feel about their visual impairment (patients with mild intellectual or cognitive deficiency may be able to reply accurately as opposed to cases with severe intellectual disability)
  • with functional or non-ophthalmic reasons of visual impairment
  • unable to provide consent/assent;
  • who do not speak/read the language

Treatment and study plan

Mixed Methods Research (MMR) using quantitative (QUAN) and qualitative (QUAL) tools

Other

A Mixed Methods Research (MMR) using quantitative (QUAN) Vision Related-QoL (VR-QoL = FVQ-CYP and VQoL-CYP) tools and psychosocial PEM-CY, and qualitative (QUAL) socio-anthropologic investigations can capture reliably children's and teenagers' Patient-Reported Outcome (PRO).

The QUAN study is a cross-sectional study including short-term re-test repetition (children/teenagers only) using the following PROMs for children/teenagers:

  • Self-reported questionnaires for patients (FVQ-CYP and VQoL-CYP)
  • For caregivers: PEM-CY questionnaires

The QUAL study will rely on the following instruments:

  • Semi-directive interviews,
  • Focus groups,
  • Field observation.

Primary outcomes

  1. real-life impact of SVI/B in children and teenagers affected by Rare Eye Diseases

    Time frame: 12 months

    To elucidate whether Patient-Reported Outcome Measures (PROMs) reflect how children/teenagers perceive their lives to be impacted by Rara Eye Diseases using Vision-related Quality of Life Questionnaire for Children and Young People - VQoL-CYP

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: SeeMyLife

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2023
Registry last updated
Aug 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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