Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2019
Source University Hospital of North Norway
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

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:

-

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Norway University Hospital of North Norway Tromsø

Sponsors (7)

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

Country where clinical trial is conducted

Norway, 

Outcome

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
See also
  Status Clinical Trial Phase
Completed NCT05703503 - Mental Health and Healthcare in Adults With Intellectual Disabilities
Recruiting NCT03823976 - Dental Treatment and Oral Rehabilitation for Adult Individuals With Intellectual Disability in General Anaesthesia