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Who Benefit From School Doctors' Health Checks?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03178331
Recruitment Status : Active, not recruiting
First Posted : June 6, 2017
Last Update Posted : March 29, 2022
Sponsor:
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
Information provided by (Responsible Party):
Kirsi Nikander, University of Helsinki

Study Description
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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.

Condition or disease Intervention/treatment
School Health Services Other: Study questionnaires

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
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Study Type : Observational [Patient Registry]
Actual Enrollment : 1013 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Who Benefit From School Doctors' Health Checks: a Prospective Study of a Screening Method in Finland
Actual Study Start Date : August 22, 2017
Actual Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 2023
Groups and Cohorts
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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
 Other: Study questionnaires
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
 Other: Study questionnaires
filled by parents, school nurse and teacher


Outcome Measures
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Primary Outcome Measures :
  1. 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".


  2. 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


Secondary Outcome Measures :
  1. Interventions and plans arising from school doctors' routine health checks [ Time Frame: Baseline ]
    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. The implementations of the school doctors' follow-up plans [ Time Frame: 12 months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Finnish public primary schools from four urban municipalities (Helsinki, Tampere, Kirkkonummi and Kerava) in Southern Finland
Criteria

Inclusion Criteria:

Grade 1 and grade 5 children

Exclusion Criteria:

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178331


Locations
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Finland
School and Student Health Services
Helsinki, Finland
School and Student Health Services
Kerava, Finland
School and Student Health Services
Kirkkonummi, Finland
School and Student Health Services
Tampere, Finland
Sponsors and Collaborators
University of Helsinki
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
Investigators
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Principal Investigator: Kirsi M Nikander, MD Doctoral School in Health Sciences, University of Helsinki, Finland
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
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kirsi Nikander, Principal Investigator, University of Helsinki
ClinicalTrials.gov Identifier: NCT03178331    
Other Study ID Numbers: HUS/2174/2017
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kirsi Nikander, University of Helsinki:
Children
Student
Questionnaires
 Screening
Health check
School health services