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

July 28, 2026 updated by: University of Wisconsin, Madison

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1040

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53706
        • Department of Kinesiology, University of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Goal Attainment Scaling (GAS)
Time Frame: Baseline to 1, 3, 6, 12, and 18 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in number of doctor visits
Time Frame: Baseline, 1, 3, 6, 12, and 18 months
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
Time Frame: Baseline, 1, 3, 6, 12, and 18 months
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"
Time Frame: Baseline, 1, 3, 6, 12, and 18 months
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
Time Frame: Baseline, 3, 12, and 18 months post-intervention
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
Time Frame: Baseline, 3, 12, and 18 months post-intervention
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
Time Frame: Baseline, 3, 12, and 18 months post-intervention
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
Time Frame: Baseline, 1, 3, 6, 12, and 18 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Patient-Centered Outcomes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Karla Ausderau, PhD, University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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