Intellectual Disabilities (F70-F79)NOHIDNCT03889002
North Health in Intellectual Disability
An observational study of Intellectual Disabilities (F70-F79), run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Intellectual disability (ID) is a diagnosis characterized by significant limitations both in intellectual functioning and in adaptive behavior as expressed in conceptual, social and practical adaptive skills. The disability originates before age 18 years. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disabilities (F70-F79)
- How many people
- 214 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2017to 9 Dec 2019
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Persons with intellectual disabilities and registered services in the municipalities in two regions localised in the north and middle of Norway will be invited to participate in the study.
Who may be able to join
- Clinical diagnosis of intellectual disability
- Age 16 or older and providing consent to participate.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Indicators, Functioning and Health Care Services in Youths and Adults With Intellectual Disabilities. A Cross-sectional Multicentre Study.
Intellectual disability (ID) is a diagnosis characterized by significant limitations both in intellectual functioning and in adaptive behavior as expressed in conceptual, social and practical adaptive skills. The disability originates before age 18 years. People with IDs will often require health- and social services throughout their lifetimes. Studies report worse health among people with IDs compared to the general population, in addition to more unmet healthcare needs and more difficulty accessing healthcare. There are also concerns about low levels of physical activity in this population.
In general health surveys in Norway do not include people with intellectual disabilities, and studies of health indicators in this group are largely lacking. Further, the unique organization of services for this group in Norway calls for specific research efforts. This project will use multinational health indicators for youths and adults with IDs in a biopsychosocial context in attempt to identify unmet health care needs to improve services. In addition to a description of the health indicators, the objective of this project is delimited to assess the health determinant physical activity level in association with body mass index (BMI) and functioning.
Read the detailed description
People with IDs are experiencing more illnesses and approximately 80% of adults 50 years or older have multimorbidities. To improve services, information about health care provision should be complemented with knowledge about the health situation and functioning in a community-based setting.
The main objectives of this study are to describe health indicators in a Norwegian population of youths and adults with IDs in relation to age, and to assess the associations between the health determinant physical activity and body mass index, physical function, activities and social participation in youths and adults with IDs.
Assessments of physical and mental health indicators, and aspects of activities and social participation according to International Classification of Functioning, Disability and Health (ICF), in relation to health determinants and unmet healthcare needs in a cross-sectional health screening survey.
The prevalence of suitable health indicators will be compared to studies in this area and from the following Norwegians population based studies: the "Tromsø-study", the "HUNT" study and the "NORSE study".
The following articles will be published as part of this project:
- A feasibility study of the use of tests like the Short Physical Performance Battery.
- An overview of the health indicators among youths and adults with intellectual disabilities in Norway, in relation to age groups.
- Presentation of levels and predictors for physical activity, as well as body mass index, in youths and adults with IDs.
- Presentation of functioning (daily activities and work) in association to levels of physical activity.
- Conditions
- Intellectual Disabilities (F70-F79)
- Keywords
- Intellectual disabilities, Health indicators, Functioning, Health care services
- Medical subject headings
- Intellectual Disability
What is being measured
The primary outcome is the main question the study is designed to answer.
Health indicators in a Norwegian population of youths and adults with intellectual disabilities.
Health indicators as measured by The POMONA Checklist of Health Indicators (P15). The health indicators include measures of socio-demographics, Health status, Health determinants and Health systems.Physical Activity is defined as a Health determinant in this study in accordance With the POMONA Health indicator classification.
Measured: Baseline
Secondary outcomes (11)
Communication Function Classification System (CFCS).
The CFCS is a 5-category rating system. Where Level 1 is best and Level 5 worst.
Measured: Baseline
The Community Integration Questionnaire (CIQ).
The scale contains 15 items to assess social role limitations and community interactions in persons With Health disorders. The items are scored on a likert-type scale. The total scale range fraom 0-29 where 29 is Maximum community integration.
Measured: Baseline
The Coherence of social care scale.
The Coherence of social care scale measures the coherence of social care and the stability of services in general. The scale uses a responscale from 1-4 (higher is better)
Measured: Baseline
The Short Physical Performance Battery (SPPB).
The SPPB measures physical functioning like balance, gait and muscular functioning. Total scale range from 0-12 (higher score indicate better functionin).
Measured: Baseline
The Timed Up and GO (TUG).
The TUG measures Balance, gait and general functioning. The time one person use to get up from a Chair, walk 3 meters and then return back to the Chair is measured in Seconds. Less time is better functioning.
Measured: Baseline
One-legged Stance test
The One-legged Stance test measures balance. The time in Seconds of how long a person can Balance on one legg is measured. Longer time is better functioning.
Measured: Baseline
The Gross Motor Function Classification Scale (GMFCS).
The GMFCS measures motor functioning. It is a 5-category rating scale where 1 is most able and 5 is most Limited functioning.
Measured: Baseline
Body mass index (BMI)
BMI is calculated by measuring height and weight.
Measured: Baseline
Overarm circumference.
Overarm circumference is measured.
Measured: Baseline
Measuring Bloodpressure.
Systolic and diastolic bloodpressure are measured.
Measured: Baseline
Waist circumference
Waist circumference is measured.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Oct 2017
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intellectual Disabilities (F70-F79)Studies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Extra Foundation for Health and Rehabilitation, The Norwegian Association for Persons with Developmental Disabilities, University of Tromso, Norwegian University of Science and Technology, Research Centre for Habilitation and Rehabilitation Models and Services, Norwegian Centre for Ageing and Health
- Responsible party
- Sponsor
- Investigators
- Audny Anke, MD, professor, Principal investigator, University Hospital of North Norway, Sykehusveien 38, 9038 Tromsø
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889002
- Sponsor's protocol ID
- 2017/811
- Acronym
- NOHID
- Status last verified
- Mar 2019
- First submitted
- 4 Mar 2019
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Olsen MI, Sondenaa E, Langballe EM, Halvorsen MB, Wilhelmsen P, Bautz-Holter E, Anke A. Use of health and dental care services in adults with intellectual disability in relation to age and intellectual disability levels. J Intellect Dev Disabil. 2023 Jun;48(2):172-183. doi: 10.3109/13668250.2022.2109823. Epub 2022 Oct 18.
PubMed 39815906
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Indicators, Functioning and Health Care Services in Youths and Adults With Intellectual Disabilities. A Cross-sectional Multicentre Study.
- ClinicalTrials.gov ID
- NCT03889002
- Acronym / sponsor ID
- NOHID / 2017/811
- Conditions
- Intellectual Disabilities (F70-F79)
- Keywords
- Intellectual disabilities, Health indicators, Functioning, Health care services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Norwegian Extra Foundation for Health and Rehabilitation, The Norwegian Association for Persons with Developmental Disabilities, University of Tromso, Norwegian University of Science and Technology, Research Centre for Habilitation and Rehabilitation Models and Services, Norwegian Centre for Ageing and Health
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 25 Mar 2019 (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.
Intellectual disability (ID) is a diagnosis characterized by significant limitations both in intellectual functioning and in adaptive behavior as expressed in conceptual, social and practical adaptive skills. The disability originates before age 18 years. People with IDs will often require health- and social services throughout their lifetimes. Studies report worse health among people with IDs compared to the general population, in addition to more unmet healthcare needs and more difficulty accessing healthcare. There are also concerns about low levels of physical activity in this population.
In general health surveys in Norway do not include people with intellectual disabilities, and studies of health indicators in this group are largely lacking. Further, the unique organization of services for this group in Norway calls for specific research efforts. This project will use multinational health indicators for youths and adults with IDs in a biopsychosocial context in attempt to identify unmet health care needs to improve services. In addition to a description of the health indicators, the objective of this project is delimited to assess the health determinant physical activity level in association with body mass index (BMI) and functioning.
Detailed description
People with IDs are experiencing more illnesses and approximately 80% of adults 50 years or older have multimorbidities. To improve services, information about health care provision should be complemented with knowledge about the health situation and functioning in a community-based setting.
The main objectives of this study are to describe health indicators in a Norwegian population of youths and adults with IDs in relation to age, and to assess the associations between the health determinant physical activity and body mass index, physical function, activities and social participation in youths and adults with IDs.
Assessments of physical and mental health indicators, and aspects of activities and social participation according to International Classification of Functioning, Disability and Health (ICF), in relation to health determinants and unmet healthcare needs in a cross-sectional health screening survey.
The prevalence of suitable health indicators will be compared to studies in this area and from the following Norwegians population based studies: the "Tromsø-study", the "HUNT" study and the "NORSE study".
The following articles will be published as part of this project:
- A feasibility study of the use of tests like the Short Physical Performance Battery.
- An overview of the health indicators among youths and adults with intellectual disabilities in Norway, in relation to age groups.
- Presentation of levels and predictors for physical activity, as well as body mass index, in youths and adults with IDs.
- Presentation of functioning (daily activities and work) in association to levels of physical activity.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Persons with intellectual disabilities and registered services in the municipalities in two regions localised in the north and middle of Norway will be invited to participate in the study.
Key inclusion criteria (2 listed)
- Clinical diagnosis of intellectual disability
- Age 16 or older and providing consent to participate.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health indicators in a Norwegian population of youths and adults with intellectual disabilities.
Time frame: Baseline
Health indicators as measured by The POMONA Checklist of Health Indicators (P15). The health indicators include measures of socio-demographics, Health status, Health determinants and Health systems.Physical Activity is defined as a Health determinant in this study in accordance With the POMONA Health indicator classification.
11 secondary outcomes
Communication Function Classification System (CFCS).
Time frame: Baseline
The Community Integration Questionnaire (CIQ).
Time frame: Baseline
The Coherence of social care scale.
Time frame: Baseline
The Short Physical Performance Battery (SPPB).
Time frame: Baseline
The Timed Up and GO (TUG).
Time frame: Baseline
One-legged Stance test
Time frame: Baseline
The Gross Motor Function Classification Scale (GMFCS).
Time frame: Baseline
Body mass index (BMI)
Time frame: Baseline
Overarm circumference.
Time frame: Baseline
Measuring Bloodpressure.
Time frame: Baseline
Waist circumference
Time frame: Baseline
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 6 Apr 2020.
- Derived from this study: PubMed 39815906Olsen MI, Sondenaa E, Langballe EM, Halvorsen MB, Wilhelmsen P, Bautz-Holter E, Anke A. Use of health and dental care services in adults with intellectual disability in relation to age and intellectual disability levels. J Intellect Dev Disabil. 2023 Jun;48(2):172-183. doi: 10.3109/13668250.2022.2109823. Epub 2022 Oct 18.
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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.
Audny Anke, MD, professor principal investigator
University Hospital of North Norway, Sykehusveien 38, 9038 Tromsø
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disabilities (F70-F79), run by University Hospital of North Norway at 1 site in Norway.
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 2 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 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Health indicators in a Norwegian population of youths and adults with intellectual disabilities. (time frame: Baseline). 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 NCT03889002, which also lists 1 linked publication.
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 6 Apr 2020.