Intellectual DisabilitiesHEALTH 4 MENCT07475117
Health Engagement & Access Through Learning, Training, and Health-coaching With People With Intellectual and/or Developmental Disabilities
A study testing Comprehensive Community Health and Regular Special Olympics programming in people with Intellectual Disabilities and Developmental Disability, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Intellectual Disabilities, Developmental Disability
- What is being tested?
- Comprehensive Community Health and Regular Special Olympics programming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Inability to complete an accessible informed assent or consent process
- Fluctuating capacity to consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Department of Kinesiology, University of Wisconsin
Madison, Wisconsin, 53706
Karla Ausderau, PhD, 608-262-0653, kausderau@wisc.edu
About this study
Official title: 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.
- Being tested
- Comprehensive Community Health, Regular Special Olympics programming
- Keywords
- Special Olympics
- Medical subject headings
- Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Community HealthBehavioural
Participants will receive group health coaching, psychoeducation, and group health education.
Regular Special Olympics programmingOther
Standard practices for those participating in Special Olympics
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Community Health (CCH) Intervention | Experimental | Participants will receive CCH Receives: Behavioral: Comprehensive Community Health; Other: Regular Special Olympics programming |
| Standard of Care | Active comparator | Participants will receive standard ongoing Special Olympics sport and health programming Receives: Other: Regular Special Olympics programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline to 1, 3, 6, 12, and 18 months
Secondary outcomes (7)
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
Measured: 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
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3, 12, and 18 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilitiesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Karla Ausderau, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07475117
- Sponsor's protocol ID
- 2025-1872
- Other IDs
- #IDD-2024C1-37360, Protocol Version 12/19/25, SOE | Kinesiology Operations
- Acronym
- HEALTH 4 ME
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07475117
- Acronym / sponsor ID
- HEALTH 4 ME / 2025-1872
- Keywords
- Special Olympics
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Community Health (CCH) Intervention | Experimental | Behavioral: Comprehensive Community Health, Other: Regular Special Olympics programmingParticipants will receive CCH |
| Standard of Care | Active comparator | Other: Regular Special Olympics programmingParticipants will receive standard ongoing Special Olympics sport and health programming |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to complete an accessible informed assent or consent process
- Fluctuating capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Community HealthParticipants will receive group health coaching, psychoeducation, and group health education. | Behavioural | Comprehensive Community Health (CCH) Intervention |
| Regular Special Olympics programmingStandard practices for those participating in Special Olympics | Other | Comprehensive Community Health (CCH) Intervention, Standard of Care |
Primary outcome
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).
7 secondary outcomes
Change in number of doctor visits
Time frame: 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
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
Change in quality of life - "Healthy Days Measure"
Time frame: Baseline, 1, 3, 6, 12, and 18 months
Change in healthcare access satisfaction
Time frame: Baseline, 3, 12, and 18 months post-intervention
Change in healthcare use satisfaction
Time frame: Baseline, 3, 12, and 18 months post-intervention
Change in self-advocacy
Time frame: Baseline, 3, 12, and 18 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karla Ausderau, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Community Health and Regular Special Olympics programming in people with Intellectual Disabilities and Developmental Disability, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karla Ausderau, PhD (608-262-0653, kausderau@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Goal Attainment Scaling (GAS) (time frame: Baseline to 1, 3, 6, 12, and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.