- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03178331
Who Benefit From School Doctors' Health Checks?
Who Benefit From School Doctors' Health Checks: a Prospective Study of a Screening Method in Finland
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim is to include 4 cities, 21 schools, 14 doctors and 1050 children from Southern Finland. From each doctor the aim is to get 25 children from both grades 1 and 5 (at ages 7 and 11) from 1-2 schools. Before the school doctor's check-up, the parents, nurses and teachers fill a questionnaire to identify any potential concerns about each child. The questions were partly chosen from the Strengths and Difficulties Questionnaire (SDQ). Additional questions concerning the child's growth, physical well-being, learning, school absenteeism and the well-being of the whole family are included. The doctor is blinded to the answers of the questionnaires. After the health check the doctors fill an electronic report including any instructions given, significant discussions and follow-up plans and their estimate of the potential benefit or harm of the medical appointment. The child and the parent fill patient-reported experience measure (PREM) forms where they evaluate the benefit or harm of the health check. The researchers compare the need for a doctor's appointment to the benefit gained. At one year after the check-up, the implementations of the follow-up plans are analyzed.
A data balance sheet has been prepared. The coordinating ethics committee of the Hospital District of Helsinki and Uusimaa (HUS) has approved the study protocol. Permissions for the study from the Department of Social Services and Healthcare and the Department of Education from all participating cities have been obtained. Informed consent will be obtained from all participating children, parents, doctors, nurses and teachers.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Helsinki, Finland
- School and Student Health Services
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Kerava, Finland
- School and Student Health Services
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Kirkkonummi, Finland
- School and Student Health Services
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Tampere, Finland
- School and Student Health Services
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Grade 1 and grade 5 children
Exclusion Criteria:
Children studying mainly in special education groups or the need of an interpreter
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
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filled by parents, school nurse and teacher
|
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
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filled by parents, school nurse and teacher
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The need for a school doctor's health check
Time Frame: Baseline
|
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
Time Frame: Baseline
|
A seven point likert scale that is based on:
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Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interventions and plans arising from school doctors' routine health checks
Time Frame: Baseline
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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
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Baseline
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The implementations of the school doctors' follow-up plans
Time Frame: 12 months
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The implementations of measures from the doctor's electronic report (yes, no, information not accessible): instruction, 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
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12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: 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 Chair: Minna Kaila, Professor, Faculty of Medicine, University of Helsinki, Finland
- Principal Investigator: Kirsi M Nikander, MD, PhD, Doctoral School in Health Sciences, University of Helsinki, Finland
Publications and helpful links
General Publications
- 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 record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HUS/2174/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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