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2/2 PROmote weight loss in obese PAD patients to preVEnt mobility loss: The PROVE Trial--DCC

Award Number: U24HL141732
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/10/2019
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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2/2 PROmote weight loss in obese PAD patients to preVEnt mobility loss: The PROVE Trial--DCC - The PROVE Trial DCC Project Summary This U24 application from the Wake Forest School of Medicine (WFSM) describes plans by experienced inves- tigators and staff to serve as the Data Coordinating Center (DCC) for the PROmote weight loss in obese PAD patients to preVEnt mobility Loss: The PROVE Trial (PROVE), a N=212 trial. We will build on our successes in dozens of large, long-term trials and epidemiologic studies. Our DCC experience will help ensure success in the implementation of the PROVE Trial by overseeing all data related aspects of the trial. We have a single speciﬁc aim: to provide project coordination, administration, data management, and biostatistical support for the PROVE Trial. We will accomplish this aim by facilitating and guiding the protocol development process, by providing scientiﬁcally sound study design, excellent operational and analytical methodology, a dedicated focus on recruitment, high quality follow-up and ﬁdelity to the intervention, monitoring safety and working with the DSMB to ensure participant safety and careful study management, working with the CCC to monitor ﬁeld cen- ters (i.e., Northwestern, Minnesota, and Tulane), and by leading development and maintenance of the protocols, manual of procedures (MOP), forms and other study documents. We believe that PROVE Trial will have nearly all the complexities of large multi-center studies, particularly for the DCC in standardization across sites. We have several strengths: (1) a team whose members are experts in the coordination of multi-center trials, including several that are ongoing, (2) experience with cardiovascular disease (CVD) trials including the current SPRINT trial, (3) experience with exercise and weight loss trials working with the intervention proposed in the PROVE trial, (4) speciﬁc project management expertise, (5) a history of efﬁcient and effective communication with ﬁeld centers, the executive committee, and the project ofﬁce, and (6) success working with Dr. McDermott (of the CCC) on two prior studies (LIFE and ENRGISE). WFSM views clinical trial conduct and coordination as a scientiﬁc undertaking, which advances through con- tinuous evaluation and innovation. While web-based randomized controlled trials (RCTs) have been conducted for almost two decades, we will continue to develop new and innovative strategies for integrating web-based technology into daily trial activities and incorporating other methods of electronic data capture into trial man- agement. We coordinated ACCORD, which was the ﬁrst large-scale RCT coordinated primarily over the web. The ACCORD system has evolved into the Database for Efﬁcient Administration of Clinical trial OperatioNs (DEACON) system for web-based trial management which we use for all of our studies. We are constantly in- venting and evaluating new features to add to the DEACON framework. The highly experienced and talented team at WFSM will create a state-of-the-art DCC for the PROVE trial using proven (pun intended) coordinating center models. Personnel will be available from day 1 and have long- standing working relationships across multiple NIH-funded studies.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $200,993 )
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Cardiovascular Diseases Research	000	6	6/30/2025	NON-COMPETING CONTINUATION	$200,993
														Subtotal = $200,993

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Cardiovascular Diseases Research	000	5	8/21/2024	NON-COMPETING CONTINUATION	$0
2024	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Cardiovascular Diseases Research	001	5	9/14/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $108,792 )
2023	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Cardiovascular Diseases Research	000	5	7/18/2023	NON-COMPETING CONTINUATION	$108,792
														Subtotal = $108,792

Issue Date FY: 2022 ( Subtotal = $95,815 )
2022	2022	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Cardiovascular Diseases Research	000	4	6/2/2022	NON-COMPETING CONTINUATION	$95,815
														Subtotal = $95,815

Issue Date FY: 2021 ( Subtotal = $97,162 )
2021	2021	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Cardiovascular Diseases Research	000	3	6/29/2021	NON-COMPETING CONTINUATION	$97,162
														Subtotal = $97,162

Issue Date FY: 2020 ( Subtotal = $134,540 )
2020	2020	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Cardiovascular Diseases Research	000	2	8/28/2020	NON-COMPETING CONTINUATION	$134,540
														Subtotal = $134,540

Issue Date FY: 2019 ( Subtotal = $221,385 )
2019	2019	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Cardiovascular Diseases Research	000	1	6/6/2019	NEW	$221,385
														Subtotal = $221,385

Grand Total All Awards = $858,687

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2/2 PROmote weight loss in obese PAD patients to preVEnt mobility loss: The PROVE Trial--DCC

Award Number: U24HL141732

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/10/2019

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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