PROactive cohort study

Patient Reported Outcomes in children and Adolescents with Chronic/life- threatening diseases and Tailored InterVentions in a digital Environment (PROactive) cohort study - PROactive cohort study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON58567

Enrollment

7000

Registered

2026-04-20

Start date

2016-12-01

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic pediatric conditions

Interventions

Within the PROactive cohort study, no medication, medical treatment or other intervention is being investigated. The study makes use of digital questionnaires (patient-reported outcomes, PROMs) and ex

Eligibility

Age

2 Years to 64 Years

Inclusion criteria

Inclusion criteria: Receiving care at the Wilhelmina Children’s Hospital (WKZ). Diagnosed with a chronic or life-threatening condition, defined as a condition lasting longer than three months, recurring more than three times per year, and/or requiring long-term treatment, medication, or medical aids.Children with medically unexplained symptoms/Persistent Physical Symptoms, such as chronic fatigue or chronic pain, without a known pathophysiological substrate, treated at a tertiary pediatric center.

Exclusion criteria

Exclusion criteria: Inability of the child and/or parent(s) to understand or read Dutch.Inability to complete online questionnaires.Children with significantly reduced cognitive functioning or developmental disorders associated with intellectual disability.

Design outcomes

Primary

Measure	Time frame
The PROactive cohort study focuses on three primary outcomes:Fatigue,Participation in daily life, such as school, social activities and independent functioning,Psychosocial well-being, including mental health and quality of life.	—

Secondary

Measure	Time frame
In addition to the primary outcomes, the PROactive cohort study collects a range of secondary outcomes to provide a broader understanding of the well-being of children and adolescents with a chronic condition. These include pain, life satisfaction, sleep, and other psychosomatic or physical symptoms.Furthermore, the study examines factors related to growing up with a chronic condition, such as biological, psychological, social and health-care-related factors, as well as experiences related to transition from pediatric to adult health care. These secondary outcomes help to identify risk factors and protective factors that influence long-term	—

Measure

Time frame

In addition to the primary outcomes, the PROactive cohort study collects a range of secondary outcomes to provide a broader understanding of the well-being of children and adolescents with a chronic condition. These include pain, life satisfaction, sleep, and other psychosomatic or physical symptoms.Furthermore, the study examines factors related to growing up with a chronic condition, such as biological, psychological, social and health-care-related factors, as well as experiences related to transition from pediatric to adult health care. These secondary outcomes help to identify risk factors and protective factors that influence long-term

—

Countries

Netherlands

Contacts

Public ContactS.L. Nijhof

Universitair Medisch Centrum Utrecht

j.w.hoefnagels@umcutrecht.nl06 5017 77 83

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026