Research Engagement With People With Intellectual and Developmental Disabilities (PCORI)

Engagement in Healthy Communities for People With Intellectual and Developmental Disabilities

The objectives of this project are to to build sustainable regional communities of Intellectual or Developmental Disabilities (IDD) stakeholders to provide ongoing input to research priorities, methodological processes, and relevant person-centered health outcomes; leverage existing Special Olympic infrastructure to nationally disseminate the toolkit in order to increase participation and engagement in research and improve health outcomes; conduct comparative effectiveness trials that incorporate people with IDD focusing on their research priorities.

Study Overview

• Status: Completed
• Conditions: Intellectual Disability; Developmental Disability; Chronic Conditions, Multiple
• Intervention / Treatment: Other: Health Research ToolKit Development

Detailed Description

This project will develop a skilled community of stakeholders through collaboration with Special Olympics to create capacity building working groups. Groups will collaborate to develop stakeholder training modules focused on leadership, research fundamentals, and health. Collaboratively developed trainings will be piloted to support revising of the Toolkit for the engagement of people with IDD in research. A range of stakeholders will be essential members of the team to design and provide critical feedback on the effectiveness of the Toolkit, research priorities, and ecologically valid methodologies. Finally, research priorities will be refined, and the research engagement Toolkit will be nationally disseminated to Special Olympics and relevant community organizations. The toolkit will include necessary training for people with IDD, as well as paid and unpaid caregivers to be engaged partners in research.

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Waisman Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Individuals with Intellectual or Developmental Disabilities (IDD)
• Caregiver or family member of the individual with IDD
• Patients/consumer
• Clinician
• Complete informed consent or assent

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: People with IDD and caregivers

Other: Health Research ToolKit Development; The Toolkit will be an accessible, structured process for people with IDD and people with IDD's paid and unpaid caregivers to be engaged partners. Learning activities are focused on leadership, information about research, health for individuals with IDD. Learning activities will include topics: What is health research? What is the health research process? How can individuals with IDD be involved in health research? Where is research happening? How to think like a researcher. Creating health stories for research and care advocacy. The learning activities will teach individuals with IDD information and allow participants to practice the learning.; Other Names: Learning Activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
READI Curriculum Development	The development of an online health research curriculum incorporating stakeholders as part of the development team.	Up to one year
Health Research Infographic Development	The development of health research infographics incorporating stakeholders as part of the development team that will bridge knowledge dissemination between researchers and people with IDD.	Up to one year

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): December 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Research; Health Disparities; Engagement; Individuals with Intellectual or Developmental Disabilities; ToolKit
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease Attributes; Neurodevelopmental Disorders; Chronic Disease; Developmental Disabilities; Intellectual Disability; Multiple Chronic Conditions
• Other Study ID Numbers: 2018-1215; A176000 (Other Identifier: UW Madison); EDUC/KINESIOLOGY (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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