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North Health in Intellectual Disability (NOHID)

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: NCT03889002
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : April 6, 2020
Sponsor:
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
Information provided by (Responsible Party):
University Hospital of North Norway

Brief 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. 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.


Condition or disease
Intellectual Disabilities (F70-F79)

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:

  1. A feasibility study of the use of tests like the Short Physical Performance Battery.
  2. An overview of the health indicators among youths and adults with intellectual disabilities in Norway, in relation to age groups.
  3. Presentation of levels and predictors for physical activity, as well as body mass index, in youths and adults with IDs.
  4. Presentation of functioning (daily activities and work) in association to levels of physical activity.

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Study Type : Observational
Actual Enrollment : 214 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Health Indicators, Functioning and Health Care Services in Youths and Adults With Intellectual Disabilities. A Cross-sectional Multicentre Study.
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : December 9, 2019
Actual Study Completion Date : December 9, 2019





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Communication Function Classification System (CFCS). [ Time Frame: Baseline ]
    The CFCS is a 5-category rating system. Where Level 1 is best and Level 5 worst.

  2. The Community Integration Questionnaire (CIQ). [ Time Frame: Baseline ]
    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.

  3. The Coherence of social care scale. [ Time Frame: Baseline ]
    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)

  4. The Short Physical Performance Battery (SPPB). [ Time Frame: Baseline ]
    The SPPB measures physical functioning like balance, gait and muscular functioning. Total scale range from 0-12 (higher score indicate better functionin).

  5. The Timed Up and GO (TUG). [ Time Frame: Baseline ]
    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.

  6. One-legged Stance test [ Time Frame: Baseline ]
    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.

  7. The Gross Motor Function Classification Scale (GMFCS). [ Time Frame: Baseline ]
    The GMFCS measures motor functioning. It is a 5-category rating scale where 1 is most able and 5 is most Limited functioning.

  8. Body mass index (BMI) [ Time Frame: Baseline ]
    BMI is calculated by measuring height and weight.

  9. Overarm circumference. [ Time Frame: Baseline ]
    Overarm circumference is measured.

  10. Measuring Bloodpressure. [ Time Frame: Baseline ]
    Systolic and diastolic bloodpressure are measured.

  11. Waist circumference [ Time Frame: Baseline ]
    Waist circumference is measured.



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • Clinical diagnosis of intellectual disability
  • Age 16 or older and providing consent to participate.

Exclusion Criteria:

-


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): NCT03889002


Locations
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Norway
University Hospital of North Norway
Tromsø, Norway
Sponsors and Collaborators
University Hospital of North Norway
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
Investigators
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Principal Investigator: Audny Anke, MD, professor University Hospital of North Norway, Sykehusveien 38, 9038 Tromsø
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Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT03889002    
Other Study ID Numbers: 2017/811
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: April 6, 2020
Last Verified: March 2019

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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 University Hospital of North Norway:
Intellectual disabilities
Health indicators
Functioning
Health care services
Additional relevant MeSH terms:
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Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurodevelopmental Disorders
Mental Disorders