Intellectual Disabilities (F70-F79) Clinical Trial
— NOHIDOfficial title:
Health Indicators, Functioning and Health Care Services in Youths and Adults With Intellectual Disabilities. A Cross-sectional Multicentre Study.
NCT number | NCT03889002 |
Other study ID # | 2017/811 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2017 |
Est. completion date | December 9, 2019 |
Verified date | March 2019 |
Source | University Hospital of North Norway |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 214 |
Est. completion date | December 9, 2019 |
Est. primary completion date | December 9, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of intellectual disability - Age 16 or older and providing consent to participate. Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Norway | University Hospital of North Norway | Tromsø |
Lead Sponsor | Collaborator |
---|---|
University Hospital of North Norway | Norwegian Centre for Ageing and Health, Norwegian Extra Foundation for Health and Rehabilitation, Norwegian University of Science and Technology, Research Centre for Habilitation and Rehabilitation Models and Services, The Norwegian Association for Persons with Developmental Disabilities, University of Tromso |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline | |
Secondary | Communication Function Classification System (CFCS). | The CFCS is a 5-category rating system. Where Level 1 is best and Level 5 worst. | Baseline | |
Secondary | 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. | Baseline | |
Secondary | 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) | Baseline | |
Secondary | 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). | Baseline | |
Secondary | 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. | Baseline | |
Secondary | 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. | Baseline | |
Secondary | 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. | Baseline | |
Secondary | Body mass index (BMI) | BMI is calculated by measuring height and weight. | Baseline | |
Secondary | Overarm circumference. | Overarm circumference is measured. | Baseline | |
Secondary | Measuring Bloodpressure. | Systolic and diastolic bloodpressure are measured. | Baseline | |
Secondary | Waist circumference | Waist circumference is measured. | Baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
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