Research Engagement With People With Intellectual and Developmental Disabilities

Intellectual Disability Clinical Trial

— PCORI  

Official title:

Engagement in Healthy Communities for People With Intellectual and Developmental Disabilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04182347
• Other study ID #: 2018-1215
• Secondary ID: A176000EDUC/KINE
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: December 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 31, 2020
• Est. primary completion date: October 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Chronic Conditions, Multiple
• Developmental Disabilities
• Developmental Disability
• Intellectual Disability
• Multiple Chronic Conditions

Intervention

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.

Locations

Country	Name	City	State
United States	Waisman Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	READI Curriculum Development	The development of an online health research curriculum incorporating stakeholders as part of the development team.	Up to one year
Primary	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