SOW 6382826 v2.pdf

STATEMENT OF WORK

Data Management Services for NIMHD Sleep-time blood Pressure and Chronic Kidney Disease Progression Study

1.0 INTRODUCTION

The mission of the National Institute on Minority Health and Health Disparities (NIMHD) is to “lead scientific research to improve minority health and reduce health disparities.” The Digital Health and Health Disparities (DHD) research area resides under the Population and Community Health Sciences Branch of NIMHD’s Intramural Research Program (IRP). DHD’s mission is to leverage health information technologies to improve minority health and reduce health disparities.

2.0 BACKGROUND

Sleep-time blood pressure is an important determinant of chronic kidney disease progression. This topic is the focus of a funded Bench-to-Bedside research study, hereafter BtB Sleep-timeBP CKD study, (https://ocr.od.nih.gov/btb/btb_program.html). The trial is registered on clinicaltrials.gov

(NCT05189418).

In this study, NIMHD is partnering with two sites to complete the research activities. The study involves recruiting patients with kidney disease and periodically collecting clinical data on their blood pressure, particularly during sleep time. Patients will participate in the study for at least one year to allow sufficient follow-up time to determine if sleep-time blood pressure is a predictor of kidney disease (and cardiovascular) outcomes.

The completion of the BtB Sleep-timeBP CKD study supports the mission of DHD research group.

The study will help DHD research team demonstrate the feasibility and utility of using digital wearables to diagnose and monitor health conditions such as blood pressure, which pave the way for the use of digital wearables in clinical practice to improve health outcomes especially among minorities who are disproportionally affected by conditions such as chronic kidney disease and hypertension.

3.0 SCOPE

The purpose of this contract is to outline the funds needed to complete research activities for the BtB Sleep-timeBP CKD study.

4.0 REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall perform the scientific and technical research tasks described below:

4.1 TASKS

Act as data manager for the BtB Sleep-timeBP CKD study.

Setting up data pipeline for the capture, download, and maintenance of data for the BtB Sleep-timeBP CKD study.

https://ocr.od.nih.gov/btb/btb_program.html

Constructing and testing an electronic data booklet used for the capture of patient data in the BtB Sleep-timeBP CKD study and train/certify all study investigators on its use and provide them appropriate access. The training course will provide: (a) detailed explanation of the ambulatory blood pressure monitoring device hardware and software, including how to care for and initialize the device, instruct patients on wearing the device, and transfer of the blood pressure data to the computer, (b) patient instructions and scheduling, and (c) detailed explanation of the study website, the electronic data booklet, dedicated software that generates clinical and ambulatory blood pressure monitoring reports, and how to interpret them.

Monitoring all study sites and ensuring the completeness of patient records, accuracy of entries in the electronic data booklet, adherence to study protocol and good clinical practice standards.

Transferring a copy of the anonymized raw data to NIMHD at the conclusion of the BtB Sleep-timeBP CKD study.

Performing analyses on the data as outlined in the study protocol and in consultation with Government and Contractor study investigators.

Recruit patients to participate in a year-long study according to the inclusion/exclusion criteria outlined in the study protocol.

Hiring a research nurse or study coordinator or similar position to facilitate patient recruitment and follow up activities during the BtB Sleep-timeBP CKD study.

Reimbursing patients for trips to the clinic per the study protocol.

Funding any miscellaneous activities such as lab expenses.

5.0 DELIVERABLES

The contractor shall:

Maintain and share with NIMHD an itemized budget and a semi-annual progress report Maintain and share with NIMHD a monthly report on recruitment and enrollment statuses of patients Deliver copy of the anonymized raw data to NIMHD at the conclusion of the BtB Sleep-timeBP

CKD study Perform the study analyses and share with NIMHD all statistical analysis plans, statistical code, and statistical and clinical reports/output

The contractor shall ship all services to the Government Project Officer, Sherine El-Toukhy, an investigator with NIMHD’s IRP at her office or clinical trial site (address TBD).

6.0 GOVERNMENT FURNISHED PROPERTY

There are no Government-owned computing equipment or property.

7.0 SECURITY REQUIREMENTS

There are no unique security requirements associated with the contract.

8.0 PERIOD OF PERFORMANCE

Base: 9/1/2022 to 8/31/2023 Option 1: 9/1/2023 to 8/31/2024