School Health ServicesNCT03178331
Who Benefit From School Doctors' Health Checks?
An observational study of School Health Services, run by University of Helsinki at 4 sites in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- School Health Services
- What is being tested?
- Study questionnaires
- How many people
- 1,013 participants
- Where
- 4 sitesFinland
- Study dates
- 22 Aug 2017to 26 Jun 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Finnish public primary schools from four urban municipalities (Helsinki, Tampere, Kirkkonummi and Kerava) in Southern Finland
Who may be able to join
- Grade 1 and grade 5 children
Who cannot join
- Children studying mainly in special education groups or the need of an interpreter
Trial locations and contacts
4 sites in 1 country.
Finland4 sites
School and Student Health Services
Helsinki
School and Student Health Services
Kerava
School and Student Health Services
Kirkkonummi
School and Student Health Services
Tampere
About this study
Official title: Who Benefit From School Doctors' Health Checks: a Prospective Study of a Screening Method in Finland
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.
Read the 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.
- Conditions
- School Health Services
- Being tested
- Study questionnaires
- Keywords
- Children, Student, Questionnaires, Screening, Health check, School health services
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study questionnairesOther
filled by parents, school nurse and teacher
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Study questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Baseline
The benefit/harm of school doctors' routine health checks
A seven point likert scale that is based on:
- 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
- School doctor's evaluation of benefit/harm
- Patient reported experience measures (PREM) of benefit/harm by child and parent
Measured: Baseline
Secondary outcomes (2)
Interventions and plans arising from school doctors' routine health checks
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
Measured: Baseline
The implementations of the school doctors' follow-up plans
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start22 Aug 2017
- Primary completion31 Aug 2018
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for School Health ServicesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,013 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Päivikki and Sakari Sohlberg Foundation, Finland, City of Helsinki, Finnish Foundation for General Practice, General Practitioners in Finland, Network of Academic Health Centres, Finland, Foundation for Paediatric Research, Finland, Pediatric Research Center, University of Helsinki
- Responsible party
- Principal investigator, Kirsi Nikander, University of Helsinki
- Investigators
- Kirsi M Nikander, MD, PhD, Principal investigator, Doctoral School in Health Sciences, University of Helsinki, FinlandElina Hermanson, MD, PhD, Study director, Pikkujätti Medical Centre for Children and Youth, FinlandSilja Kosola, MD, PhD, Study director, Helsinki University Hospital and University of Helsinki, FinlandMinna Kaila, Professor, Study chair, Faculty of Medicine, University of Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178331
- Sponsor's protocol ID
- HUS/2174/2017
- Status last verified
- May 2024
- First submitted
- 29 May 2017
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36379665Nikander 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.
PubMed 36053658Nikander 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.
PubMed 34399731Nikander 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.
PubMed 29945604
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Who Benefit From School Doctors' Health Checks: a Prospective Study of a Screening Method in Finland
- ClinicalTrials.gov ID
- NCT03178331
- Acronym / sponsor ID
- HUS/2174/2017
- Conditions
- School Health Services
- Keywords
- Children, Student, Questionnaires, Screening, Health check, School health services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Päivikki and Sakari Sohlberg Foundation, Finland, City of Helsinki, Finnish Foundation for General Practice, General Practitioners in Finland, Network of Academic Health Centres, Finland, Foundation for Paediatric Research, Finland, Pediatric Research Center, University of Helsinki
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grade 1 children | – | Other: Study questionnairesAreas 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 |
| Grade 5 children | – | Other: Study questionnairesAreas 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Finnish public primary schools from four urban municipalities (Helsinki, Tampere, Kirkkonummi and Kerava) in Southern Finland
Key inclusion criteria (1 listed)
- Grade 1 and grade 5 children
Key exclusion criteria (1 listed)
- Children studying mainly in special education groups or the need of an interpreter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study questionnairesfilled by parents, school nurse and teacher | Other | Grade 1 children, Grade 5 children |
Primary outcome
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".
The benefit/harm of school doctors' routine health checks
Time frame: Baseline
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
2 secondary outcomes
Interventions and plans arising from school doctors' routine health checks
Time frame: Baseline
The implementations of the school doctors' follow-up plans
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Derived from this study: PubMed 36379665Nikander 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.
- Derived from this study: PubMed 36053658Nikander 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.
- Derived from this study: PubMed 34399731Nikander 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.
- Derived from this study: PubMed 29945604Nikander 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsi M Nikander, MD, PhD principal investigator
Doctoral School in Health Sciences, University of Helsinki, Finland
Elina Hermanson, MD, PhD study director
Pikkujätti Medical Centre for Children and Youth, Finland
Silja Kosola, MD, PhD study director
Helsinki University Hospital and University of Helsinki, Finland
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of School Health Services, run by University of Helsinki at 4 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The need for a school doctor's health check (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03178331, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.