- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03889002
North Health in Intellectual Disability (NOHID)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tromsø, Norway
- University Hospital of North Norway
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis of intellectual disability
- Age 16 or older and providing consent to participate.
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health indicators in a Norwegian population of youths and adults with intellectual disabilities.
Time Frame: Baseline
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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.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Communication Function Classification System (CFCS).
Time Frame: Baseline
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The CFCS is a 5-category rating system.
Where Level 1 is best and Level 5 worst.
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Baseline
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The Community Integration Questionnaire (CIQ).
Time Frame: Baseline
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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.
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Baseline
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The Coherence of social care scale.
Time Frame: Baseline
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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)
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Baseline
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The Short Physical Performance Battery (SPPB).
Time Frame: Baseline
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The SPPB measures physical functioning like balance, gait and muscular functioning.
Total scale range from 0-12 (higher score indicate better functionin).
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Baseline
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The Timed Up and GO (TUG).
Time Frame: Baseline
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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.
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Baseline
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One-legged Stance test
Time Frame: Baseline
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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.
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Baseline
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The Gross Motor Function Classification Scale (GMFCS).
Time Frame: Baseline
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The GMFCS measures motor functioning.
It is a 5-category rating scale where 1 is most able and 5 is most Limited functioning.
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Baseline
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Body mass index (BMI)
Time Frame: Baseline
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BMI is calculated by measuring height and weight.
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Baseline
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Overarm circumference.
Time Frame: Baseline
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Overarm circumference is measured.
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Baseline
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Measuring Bloodpressure.
Time Frame: Baseline
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Systolic and diastolic bloodpressure are measured.
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Baseline
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Waist circumference
Time Frame: Baseline
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Waist circumference is measured.
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Baseline
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Audny Anke, MD, professor, University Hospital of North Norway, Sykehusveien 38, 9038 Tromsø
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/811
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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