NOT-OD-21-092 Notice of Special Interest (NOSI): Use of Digital Technology and Mobile Health (mHealth) to Improve Diagnosis, Assessments, Interventions, Management and Outcomes for Individuals with Down Syndrome Across the Lifespan (R21 Clinical Trial Not

The last decade has seen an explosion of new technologies aimed at assessing and improving health. Examples include wearable devices, communication aids, robotics and e-textiles, just to name a few. During this period, there have also been enormous advances in technologies that were not created for health-related purposes, but that have potential applicability to health assessments and interventions, including mobile device applications (“apps”) and social media platforms.

However, most of these technologies were originally developed for use in adults with typical cognitive and motor function. As a result, there is currently a relative paucity of valid and reliable technological tools for children and adults with intellectual and developmental disabilities (IDD) with a focus on Down syndrome (DS).

This Notice therefore invites applications specifically aimed at developing or building upon existing technological tools to improve diagnosis, assessments, interventions, management, and outcomes for infants, children, adolescents and adults with DS.

The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project was developed in response to Fiscal Year 2018, 2019, and 2020 Omnibus Appropriations Reports, which encouraged the NIH to expand its current efforts on DS and common co-occurring conditions also seen in the general population while increasing the pipeline of DS investigators. Information about projects that were funded from 2018 through 2020, as well as the INCLUDE Project Research Plan, is available on the INCLUDE Project website.

The purpose of this Notice of Special Interest (NOSI) is to support exploratory and developmental research project grant (R21) applications focused on digital technologies and/or mHealth that meet programmatic objectives for the INCLUDE Project. Sharing of resources and effective communication of outputs of appropriate interest to broader communities are a high priority of the INCLUDE Project. Applicants responding to this NOSI are strongly encouraged to describe plans for rapid sharing of data and results as well as innovative data analytics approaches (see Goal 3,NIH Strategic Plan For Data Science).

Applications in response to this NOSI should be aligned with the INCLUDE Project Research Plan, which consists of three components, two of which apply to this Notice:

  • Component 2: Cohort Study to connect existing resources and expand to inclusion of individuals with DS
  • Component 3: Inclusive clinical trials research for co-occurring conditions in individuals with DS

Projects that propose to recruit subjects with DS are encouraged to promote enrollment of research subjects in the DS patient registry supported by NIH,DS-Connect®. For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use biorepositories designated by INCLUDE staff that meet requirements for broad sharing. An NIH resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing. For those applications that generate clinical data, it is expected that the data sharing plan will include the INCLUDE Data Coordinating Center (DCC).