Health Engagement & Access Through Learning, Training, and Health-coaching With People With Intellectual and/or Developmental Disabilities (HEALTH 4 ME)

Comparing a Group Psychoeducational Health Intervention to Special Olympics Health Programming on Improving Access to Best Practice Health Care for Adults With Intellectual and Developmental Disabilities

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Developmental Disability; Intellectual Disabilities
• Intervention / Treatment: Behavioral: Comprehensive Community Health; Other: Regular Special Olympics programming

• Study Type: Interventional
• Enrollment (Estimated): 1040
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karla Ausderau, PhD; Phone Number: 608-262-0653; Email: kausderau@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • Department of Kinesiology, University of Wisconsin
      • Contact: Karla Ausderau, PhD; Phone Number: 608-262-0653; Email: kausderau@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria - Special Olympic Athletes:

• 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

Inclusion Criteria - Care Partner:

• 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

Exclusion Criteria - all:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive Community Health (CCH) Intervention; Participants will receive CCH	Behavioral: Comprehensive Community Health; Participants will receive group health coaching, psychoeducation, and group health education.; Other: Regular Special Olympics programming; Standard practices for those participating in Special Olympics
Active Comparator: Standard of Care; Participants will receive standard ongoing Special Olympics sport and health programming	Other: Regular Special Olympics programming; Standard practices for those participating in Special Olympics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of doctor visits	Participants will self-report how many times they visited their adult or family-care practitioner over the course of the study	Baseline, 1, 3, 6, 12, and 18 months
Change in number of routine health check-ups	Participants will self-report whether they received routine care throughout the study	Baseline, 1, 3, 6, 12, and 18 months
Change in quality of life - "Healthy Days Measure"	The CDC HRQOL-14 (Healthy Days Measures) scoring involves creating an Unhealthy Days Score by summing days with poor physical and mental health (max 30), and a Healthy Days Score (30 minus unhealthy days); individual items (general health, symptoms like pain, depression, energy) are often scored separately (0-30 for days, 1-5 for general health), with higher scores generally indicating worse health, except for energy/lack of fatigue, where higher is better. There isn't a single, complex summary score, but rather metrics for different aspects of quality of life, reported as means or percentages.	Baseline, 1, 3, 6, 12, and 18 months
Change in healthcare access satisfaction	Participants will self-report their satisfaction with healthcare access via responses to 3 survey items, scored on a 3-point Likert scale where 1 = easy and 3 = hard. Scores range from 3-9 with lower scores indicating greater satisfaction.	Baseline, 3, 12, and 18 months post-intervention
Change in healthcare use satisfaction	Participants will self-report their satisfaction with healthcare use via responses to 3 survey items. Items are scored on a 3-point Likert scale, where 1 = very satisfied and 3 = not satisfied. Scores range from 3-9 with higher scores indicating lower level of satisfaction.	Baseline, 3, 12, and 18 months post-intervention
Change in self-advocacy	Participants will be interviewed regarding their perceptions and understanding of health self-advocacy.	Baseline, 3, 12, and 18 months post-intervention
Change in number of participants with intellectual and/or developmental disabilities that follow-up with their primary physician	Participants will self-report whether they followed-up with their primary physician using HEALTH 4 ME tools to inform them of risk or concern about their health.	Baseline, 1, 3, 6, 12, and 18 months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Karla Ausderau, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Special Olympics
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Developmental Disabilities; Intellectual Disability
• Other Study ID Numbers: 2025-1872; Protocol Version 12/19/25 (Other Identifier: UW Madison); SOE | Kinesiology Operations (Other Identifier: UW Madison); #IDD-2024C1-37360 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No