Research Engagement With People With Intellectual and Developmental Disabilities (PCORI)
December 8, 2020 updated by: University of Wisconsin, Madison
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- Waisman Center
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-
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
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
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: People with IDD and caregivers
|
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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
READI Curriculum Development
Time Frame: Up to one year
|
The development of an online health research curriculum incorporating stakeholders as part of the development team.
|
Up to one year
|
|
Health Research Infographic Development
Time Frame: Up to one year
|
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
This is where you will find people and organizations involved with this study.
Sponsor
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 (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
Additional Relevant MeSH Terms
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
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.