Luchtbrug Junior: the Next Step

NCT05682664 | Not Yet Recruiting

• 1 other identifier: Luchtbrug Junior
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rationale: The introduction of e-health in the monitoring and management of patients with chronic conditions can be beneficial and efficient. The introduction of an online monitoring and management tool, "Luchtbrug", for children 6-16 yrs of age with asthma while reducing 50% of visits to the outpatient clinic, results in similar or improved asthma control while reducing costs. It is highly likely that this concept of e-health is suitable for other chronic conditions. Therefore the aim of the study is to investigate the added value of online monitoring and management of children with preschool wheeze (2-6 yrs of age). Objective: To assess whether the number of symptom free days can be improved using online monitoring and disease management via Luchtbrug Junior, while reducing the number of outpatient clinic visits by 50% Study design: Prospective multicentre (n=6) randomised trial in which disease management via Luchtbrug Junior will be compared with usual care. Follow-up: 12 months. Study population: children aged 2-6 yrs with preschool wheezing (multiple episode of cough, wheeze and dyspnoea). Intervention (if applicable): Children will be randomised into usual care (n=135) or partly online care via Luchtbrug Junior (n = 135) Main study parameters/endpoints: Primary objective: Number of symptom free days (SFDs) based on the TRACK questionnaire, during the last four weeks of the study (measured at 12 months). Secondary objectives: Healthcare consumption: unscheduled visits Emergency Department (ED) or outpatient clinic, unscheduled phone calls, hospital admissions) Questionnaires into: Quality of Life (QoL), cost-effectiveness (direct and indirect costs), self-management of patients, adherence to treatment, satisfaction of parents/caregivers. Usual care consists of regular visits to the outpatient clinic every 3 months after starting the study. In between visits contact with the healthcare team is by telephone as needed. At 3, 6, 9 and 12 months, patients will be asked to complete the TRACK questionnaire. Online care using Luchtbrug Junior will include visits to the outpatient clinic every 6 months after starting the study. In between visits, parents/caregivers of the patient will be asked to answer the digital version of TRACK questionnaire monthly, therefore the parents/caregivers will received email-reminders. Appropriate feedback on their TRACK-scores will be provided by their healthcare team within two working days. Any interventions such as adjustment of treatment are at the judgment of the treating pediatrician. Therapy adherence will be monitored during the study by using smart inhalers.

Conditions

eHealth; Telemedicine; Wheezing

Outcome Measures

Primary Outcomes (1)

• Change of Symptom free days / TRACK

  Number of symptom free days (SFDs) based on the TRACK questionnaire during the last four weeks of the study (measured at 12 months). The amount of SFDs varies from 0 days to 30 days a month. A higher number indicates more symptom free days in the last four weeks of the study

  TRACK questionnaire at baseline, 3, 6 , 9 and 12 months

Secondary Outcomes (6)

• Healthcare consumption

  Through study completion (follow-up of 12 months)

• Paediatric caregivers quality of life (PACQLQ) (by Juniper)

  Both groups will complete the PACQLQ at baseline, and 6 and 12 months

• Self-management of parents/caregivers

  At baseline and at 6 and 12 months

• Cost-effectiveness

  At baseline and every 3 months for 1 year

• Patient Reported Experiences Measures (PREMs)

  At baseline, after 6 and 12 months.

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Usual care for children with preschool wheeze consist of regular visits to the outpatient clinic every three months after starting the study, while in between these visits contact with the healthcare team is by telephone as needed. At inclusion and at every outpatient clinical visits (e.g. 3, 6, 9 and 12 months), parents/caregivers will be asked to update the healthcare team on disease symptoms by completing a digital version of Test for Respiratory and Asthma Control in Kids (TRACK) questionnaire.

Other: Usual care

Luchtbrug Junior (intervention)

EXPERIMENTAL

Online monitoring via Luchtbrug Junior will replace 50% of the outpatient visits. Children in the intervention group will be monitored online monthly by a digital version of TRACK.

Other: Luchtbrug Junior (online monitoring)

Interventions

Luchtbrug Junior (online monitoring) OTHER

Online monitoring via Luchtbrug Junior will replace 50% of the outpatient visits. Children in the intervention group will be monitored online monthly by a digital version of TRACK.

Luchtbrug Junior (intervention)

Usual care OTHER

Routine outpatient clinical visits every 3 months.

Usual care

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2 to 6 years with a doctor's diagnosis of preschool wheeze
• Children have an indication for regular follow-up of at least one year by a paediatrician because of respiratory symptoms;
• Children are treated with inhaler medication, including inhaled corticosteroids;
• A history of three episodes of wheezing managed by a healthcare professional of which at least one was observed by a paediatrician in the last 12 months prior to the study, or:
• Informed consent of parents/caregivers

You may not qualify if:

• Underlying chronic cardiopulmonary or neuromuscular condition, or known recurrent aspirations;
• Underlying syndromes associated with pulmonary comorbidities;
• Prematurity \<36 weeks after gestation;
• Inability of parents/caregivers/caretakers to understand and/or read Dutch;
• No access to a smartphone and/or internet.

Sponsors & Collaborators

• Radboud University Medical Center: lead

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lara van den Wijngaart, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara van den Wijngaart, MD, PhD

CONTACT

+31243614430; lara.vandenwijngaart@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 12, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 10, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share