# Development of a Qualification Plan for an Activity Monitor-Based Endpoint Measure in Chronic Heart Failure (DDT COA #000114)

> **NIH FDA U01** · CRITICAL PATH INSTITUTE · 2021 · $249,970

## Abstract

ABSTRACT
Chronic heart failure (CHF) results when the heart cannot pump enough blood to meet the
body’s needs. Approximately 6.5 million people in the United States and 26 million people
worldwide have heart failure. Specific CHF symptoms, such as shortness of breath, chest pain,
and fatigue, are contributing factors to reduced activity and limitations in ability to perform daily
activities. Hence, in conjunction with the assessment of patient-reported symptoms and impacts
of CHF, regulators and sponsors have expressed interest in novel measures of daily activity that
leverage wearable devices. To help address this measurement opportunity, the CHF Working
Group’s proposed activity monitor-based endpoint measure was accepted into the Center for
Drug Evaluation and Research’s COA Qualification Program (DDT #000114) on May 3, 2019. It
is intended to assess aspects of objectively measured physical activity that reflect a person with
CHF’s ability to perform meaningful daily activities. To further this qualification effort, the
proposed project will result in the development and submission of a Qualification Plan (QP).
A concept elicitation study was conducted to generate qualitative evidence regarding the day-to-
day physical activities that bring purpose and meaning to the lives of persons with CHF.
Activities frequently reported involved light to moderate physical activity (e.g., cleaning, cooking,
doing laundry, and gardening) and walking (e.g., shopping and going to appointments). The
next step will be to form an advisory panel, composed of individuals with expertise in the
identification of clinically meaningful activity monitor-based outcomes, to review the qualitative
study findings and gain consensus on the existing (or proposed novel) activity monitor metric(s)
that best reflect/capture the meaningful aspect of health represented by these activities. Once
there is agreement on the specific activity monitor-based metric(s) to be evaluated further, we
will proceed with development of the QP. The compiled QP will address the CHF Working
Group’s research plan for generating the quantitative evidence necessary to support
qualification of the activity monitor-based endpoint measure for use in CHF drug development.
Our approach includes two aims: (1) convene an advisory panel to provide critical input
regarding the results of the qualitative study and gain consensus on the specific activity monitor
metric(s) that will be the focus of the QP, and (2) prepare and submit a QP for the activity
monitor-based endpoint measure. The long-term result of this project will be a qualified, publicly
available activity monitor-based endpoint measure, which will fill a critical gap in the assessment
of physical activity in CHF treatment trials for emerging innovative therapies.

## Key facts

- **NIH application ID:** 10410801
- **Project number:** 1U01FD007467-01
- **Recipient organization:** CRITICAL PATH INSTITUTE
- **Principal Investigator:** Stephen Joel Coons
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2021
- **Award amount:** $249,970
- **Award type:** 1
- **Project period:** 2021-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10410801

## Citation

> US National Institutes of Health, RePORTER application 10410801, Development of a Qualification Plan for an Activity Monitor-Based Endpoint Measure in Chronic Heart Failure (DDT COA #000114) (1U01FD007467-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10410801. Licensed CC0.

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