NCT03178331

Brief Summary

The aims of the study are 1) to evaluate the potential benefits or harm of school doctors' routine health checks and 2) to explore whether part of the school doctors' routine health checks can be omitted using study questionnaires which address the parents', school nurses' and teachers' concerns regarding each child.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,013

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2017

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

August 22, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2023

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 29, 2017

Last Update Submit

May 13, 2024

Conditions

Keywords

ChildrenStudentQuestionnairesScreeningHealth checkSchool health services

Outcome Measures

Primary Outcomes (2)

  • The need for a school doctor's health check

    The need for a school doctor's health check according to the study questionnaires filled by parents, nurse and teacher. Areas of concern in study questionnaires: growth, physical symptom, hearing, school absenteeism, learning, concentration, behavior, emotions, getting on with others, eating, sleeping, wellbeing of family, free description of concern, wish to talk about concerns with the school doctor The responses will be categorized into three groups: 1) "Needs doctor's health check" 2) "No need for doctor's health check and 3) "Consultation of the nurse or doctor may be sufficient".

    Baseline

  • The benefit/harm of school doctors' routine health checks

    A seven point likert scale that is based on: 1. Measures from the doctor's electronic report: instruction, other significant discussion, referral to laboratory test/physiotherapist/speech therapist/nutritionist/secondary care, guidance to or contact of a specialised worker or other unit: teacher/special education teacher/school psychologist/school social worker/health center/family guidance center/home service/child welfare, prescription, medical imaging, individual follow-up plan 2. School doctor's evaluation of benefit/harm 3. Patient reported experience measures (PREM) of benefit/harm by child and parent

    Baseline

Secondary Outcomes (2)

  • Interventions and plans arising from school doctors' routine health checks

    Baseline

  • The implementations of the school doctors' follow-up plans

    12 months

Study Arms (2)

Grade 1 children

Areas of concern in study questionnaires: growth, physical symptom, hearing, school absenteeism, learning, concentration, behavior, emotions, getting on with others, eating, sleeping, wellbeing of family, free description of concern, wish to talk about concerns with the school doctor

Other: Study questionnaires

Grade 5 children

Areas of concern in study questionnaires: growth, physical symptom, hearing, school absenteeism, learning, concentration, behavior, emotions, getting on with others, eating, sleeping, wellbeing of family, free description of concern, wish to talk about concerns with the school doctor

Other: Study questionnaires

Interventions

filled by parents, school nurse and teacher

Grade 1 childrenGrade 5 children

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Finnish public primary schools from four urban municipalities (Helsinki, Tampere, Kirkkonummi and Kerava) in Southern Finland

You may qualify if:

  • Grade 1 and grade 5 children

You may not qualify if:

  • Children studying mainly in special education groups or the need of an interpreter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

School and Student Health Services

Helsinki, Finland

Location

School and Student Health Services

Kerava, Finland

Location

School and Student Health Services

Kirkkonummi, Finland

Location

School and Student Health Services

Tampere, Finland

Location

Related Publications (4)

  • Nikander K, Hermanson E, Vahlberg T, Kaila M, Kosola S. Parent, teacher, and nurse concerns and school doctor actions: an observational study of general health checks. BMJ Open. 2022 Nov 15;12(11):e064699. doi: 10.1136/bmjopen-2022-064699.

  • Nikander K, Kosola S, Vahlberg T, Kaila M, Hermanson E. Associating school doctor interventions with the benefit of the health check: an observational study. BMJ Paediatr Open. 2022 Feb;6(1):e001394. doi: 10.1136/bmjpo-2021-001394.

  • Nikander K, Hermanson E, Vahlberg T, Kaila M, Sannisto T, Kosola S. Associations between study questionnaire-assessed need and school doctor-evaluated benefit of routine health checks: an observational study. BMC Pediatr. 2021 Aug 16;21(1):346. doi: 10.1186/s12887-021-02810-0.

  • Nikander K, Kosola S, Kaila M, Hermanson E. Who benefit from school doctors' health checks: a prospective study of a screening method. BMC Health Serv Res. 2018 Jun 27;18(1):501. doi: 10.1186/s12913-018-3295-3.

Study Officials

  • Kirsi M Nikander, MD, PhD

    Doctoral School in Health Sciences, University of Helsinki, Finland

    PRINCIPAL INVESTIGATOR
  • Elina Hermanson, MD, PhD

    Pikkujätti Medical Centre for Children and Youth, Finland

    STUDY DIRECTOR
  • Silja Kosola, MD, PhD

    Helsinki University Hospital and University of Helsinki, Finland

    STUDY DIRECTOR
  • Minna Kaila, Professor

    Faculty of Medicine, University of Helsinki, Finland

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 6, 2017

Study Start

August 22, 2017

Primary Completion

August 31, 2018

Study Completion

June 26, 2023

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations