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

NCT04484272 | Recruiting

• 3 other identifiers: IRB202000984-N5R01NR018848-03PRO00028515
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 1

Brief Summary

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. Aim 2: To determine the long-term effects of YCWS. 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.).

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (3)

• Stress intensity scale

  This 3-item scale asks patients to report their current, least, and worst stress intensity in the past 24 hours, on a scale of 0 (no stress) to 10 (stress as bad as it could be)

  Baseline through Month 6

• Pain intensity scale

  Pain intensity Scale. This 3-item scale asks patients to report their current, least, and worst pain intensity in the past 24 hours, on a scale of 0 (no pain) to 10 (pain as bad as it could be).

  Baseline through Month 6

• Opioid use

  We will use PAINReportIt®87-89 software program (Nursing Consult LLC, Seattle, WA) to collect data on names and doses of scheduled and as needed (PRN) opioid analgesics at baseline and updated at Week 8 and 6 month. We will use Wisepill medication event monitoring system (MEMS) to collect data on opioid use.

  Baseline through Month 6

Study Arms (2)

Control Group

ACTIVE COMPARATOR

(Self-monitoring of pain, stress, and opioid use + alerts/reminders). During efficacy trial (Weeks 1-8), patients will monitor their stress, pain, and opioid use daily. We will send system-generated alerts/reminders every 24 hours to patients via phone call, text, or email to facilitate data entry. During the long-term period (months 3-6), patients will continue to monitor their stress, pain, and opioid use daily and receive only system generated alerts/reminders via messaging service or staff cell phone.

Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders.

Experimental Group

EXPERIMENTAL

(Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS \[three video banks of RDE + Support\]). Self-monitoring, using video banks, and getting support elements comprise the YCWS intervention. The YCWS App is comprised of three tabs displayed across the top of the screen, namely, self-monitoring, video banks, and support. During the short-term trial (Weeks 1-8), patients will monitor their stress and pain daily and have access to three video banks from which to choose their daily intervention. We will send automated system-generated alerts/reminders every 24 hours to experimental group patients via phone call, text, or email to facilitate intervention use. During the long-term period (months 3-6), only system-generated alerts/reminders will be available.

Behavioral: Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).

Interventions

Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]). BEHAVIORAL

Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. \[three video banks of RDE + Support\]).

Experimental Group

Self-monitoring of pain, stress, and opioid use + alerts/reminders. BEHAVIORAL

Self-monitoring of pain, stress, and opioid use + alerts/reminders.

Control Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with diagnosis of SCD (e.g., HbSS, HbSC, HbS-beta-0 thalassemia, and HbS-beta+ thalassemia); (b) reports moderate to severe level of pain (\>3 on 0-10 scale) related to SCD within previous 24 hours; (c) uses opioid analgesics on "as needed" or "continuous" basis (d) who speaks and reads English; and (e) is 18 years of age or older

You may not qualify if:

• are legally blind; (b) physically unable to complete procedures; (c) previously participated in our relaxation/distraction intervention feasibility study

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Related Publications (1)

• Ezenwa MO, Yao Y, Mandernach MW, Fedele DA, Lucero RJ, Corless I, Dyal BW, Belkin MH, Rohatgi A, Wilkie DJ. A Stress and Pain Self-management mHealth App for Adult Outpatients With Sickle Cell Disease: Protocol for a Randomized Controlled Study. JMIR Res Protoc. 2022 Jul 29;11(7):e33818. doi: 10.2196/33818.

  PMID: 35904878 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Caffeine; Palliative Care

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Miriam O. Ezenwa

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muntaha Ali, MS

CONTACT

352-273-6520; muntahaali@ufl.edu

Amelia Greenlee

CONTACT

352-273-6356; greenleeal@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 23, 2020
• Study Start: April 29, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)