# A Stress and Pain Self-management m-Health App for Adult Outpatients with Sickle Cell Disease

> **NIH NIH R01** · UNIVERSITY OF FLORIDA · 2022 · $521,089

## Abstract

Project Summary/Abstract
Our long-term goal is to reduce stress and improve sickle cell disease (SCD) pain control with less opioid use
through an intervention with self-management relaxation/distraction exercises (RDE), named You Cope, We
Support (YCWS). Americans living with SCD suffer recurrent episodes of acute and chronic pain, both of which
are exacerbated by stress. Building on the successes of our prior formative studies, we now propose a well-
designed, appropriately powered study to test efficacy of YCWS on outcomes (pain intensity, stress intensity,
opioid use) in adults with SCD. We propose to recruit 170 adults for a randomized controlled trial of the short-
term (8 weeks) and long-term (6 months) effects of YCWS on outcomes (pain, stress, and opioid use).
Stratified on worst pain intensity (<=5; >5), we will randomly assign patients to groups: 85 to Control (Self-
monitoring of outcomes + alerts/reminders), and 85 to Experimental (Self-monitoring of outcomes +
alerts/reminders + use of YCWS [RDE + Support]). We will ask participants to report outcomes daily. During
weeks 1-8, we will send system-generated alerts/reminders to both groups via phone call, text, or email to
facilitate data entry (both groups) and intervention use support (experimental). If the patient does not enter
data after 24 hours, study support staff will contact him/her for data entry trouble-shooting (both groups) and
YCWS use (experimental). We will time stamp and track participants' online activities to understand the study
context and conduct exit interviews on acceptability of the staff and system-generated support. We will analyze
data using mixed-effects regression models (short-term, long-term) to account for repeated measurements
over time and utilize machine learning to construct and evaluate models predictive of outcomes. Specific aims
are: Aim 1: To determine the short-term effects of YCWS. Hypothesis: in the first 8 weeks, compared to the
control group, the experimental group will report reductions in pain intensity (primary outcome, 0-10 scale) and
secondary outcomes--stress intensity (0-10 scale) and opioid use (oral morphine equivalence [OME]). Aim 2:
To determine the long-term effects of YCWS. Hypothesis: in months 3-6, compared to control group, the
experimental group will report reductions in pain intensity (primary outcome, 0-10 scale) and secondary
outcomes--stress intensity (0-10 scale) and opioid use (oral morphine equivalence [OME]). Aim 3
(exploratory): Using machine learning, to develop and evaluate models that predict patient outcomes based
on their group assignment and on their personal (e.g., self-efficacy, sex, education, family income, computer
experience, etc.,) and environmental characteristics (e.g., distance from care, quality of cell connection, etc.).
Findings will guide future studies on the implementation of the m-Health enabled YCWS self-management
intervention in the real world by adults with SCD. Findings also will guide ...

## Key facts

- **NIH application ID:** 10416042
- **Project number:** 5R01NR018848-03
- **Recipient organization:** UNIVERSITY OF FLORIDA
- **Principal Investigator:** Miriam Omelebele Ezenwa
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $521,089
- **Award type:** 5
- **Project period:** 2020-09-07 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10416042

## Citation

> US National Institutes of Health, RePORTER application 10416042, A Stress and Pain Self-management m-Health App for Adult Outpatients with Sickle Cell Disease (5R01NR018848-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10416042. Licensed CC0.

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