Studies

Observational Recruiting

NCT05550545 on ClinicalTrials.gov

Infant RSV Infections and Health-related Quality of Life of Families

Official title: ResQ Family: Impact of Respiratory Syncytial Virus (RSV) Hospitalisation on Quality of Life of Families - A Multi-Country Study

  • Sponsor: European Foundation for the Care of Newborn Infants
  • Collaborators: Respiratory Syncytial Virus Foundation (ReSViNET), European Society for Paediatric Research (ESPR), Union of European Neonatal and Perinatal Societies (UENPS)
  • Enrollment: 120 (Estimated)
  • Study start: 2022-09-29 (Actual)
  • Primary completion: 2023-05-01 (Estimated)
  • Study completion: 2024-06-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

Until today, there is only little information available on how severe RSV infection leading to hospitalisation of the infant impacts the quality of life of affected families. For the ResQ Family project, an online questionnaire will be used to survey parents or caregivers of children up to 24 months currently or recently hospitalised (length of hospital stay of at least 12 hours and hospital admission no longer than 4 weeks ago) due to RSV infection.

The aim of the ResQ Family project is to find out how infant RSV hospitalisation impacts the quality of life of affected children and their families. The goal is further to provide scientific evidence on the burden of RSV and raise awareness among all relevant stakeholders including healthcare professionals and patient representatives, decision-makers and the general public. The project will run until June 2024. Data collection will take place during the RSV season from fall 2022 to spring 2023 in four European countries: France, Germany, Italy, and Sweden.

Conditions

  • RSV Infection
  • Quality of Life
  • Infant ALL
  • Caregiver Burden
  • Family

Intervention / Treatment

  • Other: cohort study

Primary Outcome Measures

  • Health-related quality of life of parents/caregivers and family functioning (Baseline (Day 0))
    The 36-item version of the Pediatric Quality of Life Inventory Family Impact Module (PedsQLTM FIM) was used to assess the quality of life of parents/caregiver when the child was infected and hospitalized for RSV. It composes of six scales measuring parent self-reported functioning: 1) Physical functioning (6 items), 2) Emotional functioning (5 items), 3) Social functioning (4 items), 4) Cognitive functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and in addition two scales measuring parent-reported family functioning: 7) Daily activities (3 items) and 8) Family relationships (5 items). Each of the items have five Likert response options: 0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often, 4= almost always. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact).
  • Health-related quality of life of parents/caregivers and family functioning (6 weeks follow-up (Week 6))
    The 36-item version of the Pediatric Quality of Life Inventory Family Impact Module (PedsQLTM FIM) was used to assess the quality of life of parents/caregiver when the child was infected and hospitalized for RSV. It composes of six scales measuring parent self-reported functioning: 1) Physical functioning (6 items), 2) Emotional functioning (5 items), 3) Social functioning (4 items), 4) Cognitive functioning (5 items), 5) Communication (3 items), 6) Worry (5 items), and in addition two scales measuring parent-reported family functioning: 7) Daily activities (3 items) and 8) Family relationships (5 items). Each of the items have five Likert response options: 0 = never a problem, 1 = almost never, 2 = sometimes, 3 = often, 4= almost always. Items are reverse-scored and linearly transformed to a 0-100 scale (0 = 100, 1 = 75, 2 = 50, 3 = 25, 4 = 0), so that higher scores indicate better functioning (less negative impact).

Countries

Germany

Locations and Investigators

  • EFCNI, Munich, Germany (Recruiting)
    • Christina Tischer, PhD

Study Officials

  • Johanna Kostenzer, PhD (Principal Investigator) — European Foundation for the Care of Newborn Infants