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

NCT05550545 | Unknown

• 1 other identifier: 2022-3307
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

RSV; Respiratory syncytial virus; quality of life; health literacy; infants; children; caregiver burden

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life of parents/caregivers and family functioning

  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).

  Baseline (Day 0)

• Health-related quality of life of parents/caregivers and family functioning

  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).

  6 weeks follow-up (Week 6)

Secondary Outcomes (6)

• Socio-demographics

  Baseline (Day 0)

• Child's co-morbidities

  Baseline (Day 0)

• Child's symptoms during RSV infection and hospitalisation

  Baseline (Day 0)

• Child's symptoms after RSV infection and hospitalisation

  6 weeks follow-up (Week 6)

• Other

  Baseline (Day 0)

Study Arms (1)

Parents/caregivers of RSV-infected infants

Other: cohort study

Interventions

cohort study OTHER

Please note that this is an observational study; not applicable

Parents/caregivers of RSV-infected infants

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents or caregivers of children younger than 24 months of age with a hospitalisation for at least 12 hours due to RSV infection in Germany, Sweden, Italy or France.

You may qualify if:

• Parents or caregivers of children younger than 24 months of age with a hospitalisation for at least 12 hours due to RSV infection
• Living in Germany, Sweden, Italy or France
• The diagnosis can either be confirmed by a test such as ELISA/IFT/PCR from nasal secretion, sputum or throat swab or by a doctor based on specific symptoms typically during the RSV season
• They can be reached during or after hospitalisation, ideally right after the discharge from hospital but at least within four weeks after hospital admission

Sponsors & Collaborators

• Global Foundation for the Care of Newborn Infants: lead
• Respiratory Syncytial Virus Foundation (ReSViNET): collaborator
• European Society for Paediatric Research (ESPR): collaborator
• Union of European Neonatal and Perinatal Societies (UENPS): collaborator

Study Sites (1)

EFCNI

Munich, Bavaria, 81379, Germany

RECRUITING

Related Publications (1)

• Trautmannsberger I, Plagg B, Adamek I, Mader S, de Luca D, Esposito S, Silfverdal SA, Zimmermann LJI, Tischer C; ResQ Family study group. The Multifaceted Burden of Respiratory Syncytial Virus (RSV) Infections in Young Children on the Family: A European Study. Infect Dis Ther. 2024 Jul;13(7):1531-1573. doi: 10.1007/s40121-024-00989-0. Epub 2024 May 20.

  PMID: 38767780 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Caregiver Burden

Interventions

Cohort Studies

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Johanna Kostenzer, PhD

  Global Foundation for the Care of Newborn Infants

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Tischer, PhD

CONTACT

+49 (0)89 / 89083260; research@efcni.org

Christina Tischer, PhD

CONTACT

+49 (0)89 / 89083260; christina.tischer@efcni.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Scientific Affairs

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 22, 2022
• Study Start: September 29, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2024
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)