Health Engagement & Access Through Learning, Training, and Health-coaching With People With Intellectual and/or Developmental Disabilities

Browse trials for

• Intellectual Disability 387
• Developmental Disabilities 230

Keywords

• Special Olympics

Intellectual Disability

387 studies on the registry are indexed under Intellectual Disability; 105 are open to participants now.

This study's planned enrollment of 1,040 is above the median of 58 across 248 interventional studies indexed under Intellectual Disability.

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.

Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Comprehensive Community Health (CCH) Intervention

  Participants will receive CCH

  Behavioral: Comprehensive Community Health · Other: Regular Special Olympics programming

• Active comparator
  Standard of Care

  Participants will receive standard ongoing Special Olympics sport and health programming

  Other: Regular Special Olympics programming

Interventions

• BehavioralComprehensive Community Health

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

• OtherRegular Special Olympics programming

  Standard practices for those participating in Special Olympics

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).

   Time frame: Baseline to 1, 3, 6, 12, and 18 months

Secondary outcomes

1. 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

   Time frame: Baseline, 1, 3, 6, 12, and 18 months

2. Change in number of routine health check-ups

   Participants will self-report whether they received routine care throughout the study

   Time frame: Baseline, 1, 3, 6, 12, and 18 months

3. 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.

   Time frame: Baseline, 1, 3, 6, 12, and 18 months

4. 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.

   Time frame: Baseline, 1, 3, 6, 12, and 18 months

5. 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.

   Time frame: Baseline, 3, 12, and 18 months post-intervention

6. 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.

   Time frame: Baseline, 3, 12, and 18 months post-intervention

7. Change in self-advocacy

   Participants will be interviewed regarding their perceptions and understanding of health self-advocacy.

   Time frame: Baseline, 3, 12, and 18 months post-intervention

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Analytic code