NCT07475117

Brief Summary

The purpose of this study is to see if a combination of an educational curriculum and health coaching embedded within Special Olympics improves health outcomes and healthcare access compared to regular Special Olympics sport and health programming for adults with intellectual and/or developmental disabilities.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
1,040

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

June 11, 2026

Status Verified

March 1, 2026

Enrollment Period

4.7 years

First QC Date

March 11, 2026

Last Update Submit

June 9, 2026

Conditions

Keywords

Special Olympics

Outcome Measures

Primary Outcomes (1)

  • Change in Goal Attainment Scaling (GAS)

    GAS is measured using three participant-identified goals, each assigned a priority weight from 1 to 3 (3=most important goal to participant). At each assessment, each goal is assigned a score from -2 to +2, with 0 representing expected level of attainment and 2 indicating much more than expected level of attainment; goals are assigned a score of -2 at baseline. GAS score levels across all three participant goals are converted into a standardized single GAS T-score for each participant. The range of possible T-scores is 23.56 (all three goals with GAS score of -2) to 76.44 (all three goals with GAS score of +2).

    Baseline to 1, 3, 6, 12, and 18 months

Secondary Outcomes (7)

  • Change in number of doctor visits

    Baseline, 1, 3, 6, 12, and 18 months

  • Change in number of routine health check-ups

    Baseline, 1, 3, 6, 12, and 18 months

  • Change in number of participants with intellectual and/or developmental disabilities that follow-up with their primary physician

    Baseline, 1, 3, 6, 12, and 18 months

  • Change in quality of life - "Healthy Days Measure"

    Baseline, 1, 3, 6, 12, and 18 months

  • Change in healthcare access satisfaction

    Baseline, 3, 12, and 18 months post-intervention

  • +2 more secondary outcomes

Study Arms (2)

Comprehensive Community Health (CCH) Intervention

EXPERIMENTAL

Participants will receive CCH

Behavioral: Comprehensive Community HealthOther: Regular Special Olympics programming

Standard of Care

ACTIVE COMPARATOR

Participants will receive standard ongoing Special Olympics sport and health programming

Other: Regular Special Olympics programming

Interventions

Participants will receive group health coaching, psychoeducation, and group health education.

Comprehensive Community Health (CCH) Intervention

Standard practices for those participating in Special Olympics

Comprehensive Community Health (CCH) InterventionStandard of Care

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Currently participating in Special Olympics programming at a state agency in the study
  • Has a medical or educational diagnosis of intellectual and/or developmental disabilities
  • Between the ages of 21-65
  • Has at least weekly contact with a family member or care partner who is willing and able to participate
  • Fluent in English
  • Care partner for the participating Special Olympic Participant/Athlete
  • At least 21 years of age
  • Has at least weekly contact with Special Olympic Participant/Athlete who is willing and able to participate
  • Fluent in English

You may not qualify if:

  • Inability to complete an accessible informed assent or consent process
  • Fluctuating capacity to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology, University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

MeSH Terms

Conditions

Intellectual DisabilityDevelopmental Disabilities

Condition Hierarchy (Ancestors)

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

Study Officials

  • Karla Ausderau, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karla Ausderau, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2026

First Posted

March 16, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

March 1, 2031

Study Completion (Estimated)

March 1, 2031

Last Updated

June 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Coded data will be submitted to the Patient-Centered Outcomes Data Repository (PCODR) at the Inter-university Consortium for Political and Social Research (CPSR) at the University of Michigan, as required by PCORI. The shared dataset will include participant-level quantitative data, relevant study documentation, and supporting materials necessary to enable secondary analyses. Prior to submission to PCODR, all data will be de-identified but will have study ID codes. Direct identifiers will be removed, and dates will be generalized or shifted as appropriate to minimize re-identification risk.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations