Addressing knowledge gaps by multi-level research design to optimize clinical trial development in order to reduce fracture burden for adults with neurodevelopmental disabilities

Ended Project Grant Awarded Last action

Award ID
R01AR076994
Recipient
Awarding agency
Obligated
$1,471,642

Award facts

Completion date
Originally
Funding
  • $1,231,402.00 Federal
  • $240,240.00 Non-federal
Place of performance
Michigan, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Individuals with neurodevelopmental disabilities (NDDS) have unmet healthcare needs and heightened susceptibility for skeletal fragility and non-trauma fracture (NTFX) throughout their lifespan, resulting in greater risk for early development of chronic diseases and early mortality. There is a fundamental GAP in the understanding of skeletal pathology, burden of NTFX, and clinical care needed to prevent and manage skeletal fragility for these vulnerable adult populations. Continued existence of this GAP represents a major public health issue because the adult population with NDDS is growing, and poorly managed healthcare could lead to a disproportionate rise in the disease burden attributable to adults with NDDS. The long-term goal is to identify and address unmet healthcare needs to improve healthful aging for individuals with NDDS. The objective of this multi-level study is to address fundamental knowledge gaps in order to improve clinical care for skeletal fragility and to optimize clinical trial design to reduce the NTFX burden for adults with NDDS. Aim 1 will identify risk factors for NTFX and determine the post-NTFX burden of diseases and mortality among a large, heterogeneous sample of adults with and without NDDS by leveraging nationwide private and public administrative claims data from 2012-2019. This information will be used to inform intervention strategies and determine important health- related outcome measures to be used as benchmarks of success for future clinical trials. Aim 2 will determine causes of NTFX among a clinical sample of adults with NDDS by leveraging electronic medical records. This information will be used to inform intervention strategies for future clinical trials. In aim 3, mixed methods will be used to develop and then administer a survey to gauge patient awareness on the importance of NTFX prevention on their overall health and function, willingness to participate in NTFX prevention programs (e.g., clinical trial), and barriers and facilitators that may impact clinical trial participation. This information will be used to identify obstacles, opportunities, and solutions to design successful clinical trials to reduce the burden of NTFX specific to the needs of these complex patient groups. The research is clinically innovative because IT will challenge the current paradigm regarding NTFX assessment and evaluation, which is typically focused on older adults and postmenopausal women. The research is also innovative because of the use of a complementary, multi-level research design for information gathering across national, clinic, and patient levels to optimize clinical care and clinical trial design. The research is significant because IT is expected to improve clinical care, increase public health awareness about the burden of skeletal fragility, and optimize clinical trial design to reduce the NTFX burden for these underserved populations. The purpose of this research is aligned with the purpose of PAR-18-597 and many research priorities of niams, including cross-cutting topics of health disparities and clinical research topics from bone biology and musculoskeletal biology and diseases.

Transactions

Action Federal Non-federal Date
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $0 $0
Amendment $171,600 $0
Amendment $171,600 $0
Amendment $203,861 $0
Amendment $203,861 $0
Amendment $240,240 $0
Original award $240,240 $240,240

Subawards

Subrecipient Amount Awarded
Cardinal Health 119, LLC Aim 1 The work to do is as follows: 1. From 02/2024-06/2024, explore the use of SEER-Medicare data. This involves drafting the contract with SEER and Medicare… $74,095

Quick answers

Who received award R01AR076994?

R01AR076994 was awarded to Regents Of The University Of Michigan by National Insititue of Arthritis and Musculoskeletal and Skin Diseases (National Institutes of Health) on September 23, 2021.

How much is award R01AR076994 worth?

$1,471,642 has been obligated on R01AR076994: $1,231,402 in federal funding and $240,240 in non-federal funding.

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