NCT03889002

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
Last Updated

April 6, 2020

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

March 4, 2019

Last Update Submit

April 3, 2020

Conditions

Keywords

Intellectual disabilitiesHealth indicatorsFunctioningHealth care services

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Communication Function Classification System (CFCS).

    Baseline

  • The Community Integration Questionnaire (CIQ).

    Baseline

  • The Coherence of social care scale.

    Baseline

  • The Short Physical Performance Battery (SPPB).

    Baseline

  • The Timed Up and GO (TUG).

    Baseline

  • +6 more secondary outcomes

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Norway

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Audny Anke, MD, professor

    University Hospital of North Norway, Sykehusveien 38, 9038 Tromsø

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2019

First Posted

March 25, 2019

Study Start

October 1, 2017

Primary Completion

December 9, 2019

Study Completion

December 9, 2019

Last Updated

April 6, 2020

Record last verified: 2019-03

Locations