YCWS App for Sickle Cell Disease

Overseen By Amelia Greenlee

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must be taking: Opioid analgesics

Disqualifiers: Legally blind, physically unable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

185 Participants Needed

Trial Summary

What is the purpose of this trial?

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.).

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since the study involves participants who use opioid analgesics, it seems likely that you can continue your current medication regimen.

What data supports the effectiveness of the YCWS App treatment for Sickle Cell Disease?

Research shows that mobile health tools, like the SMART app, help sickle cell disease patients monitor and manage pain effectively. Additionally, using smartphones for self-monitoring improves communication with healthcare providers, which can enhance pain management. ^{1 2 3 4 5}

Is the YCWS App for Sickle Cell Disease safe for humans?

The OpPill application, which is similar to the YCWS app, was tested with sickle cell disease patients and was found to be easy to use and relevant for their care. Most users rated it highly for engagement, functionality, aesthetics, and information quality, suggesting it is generally safe for human use. ^{1 2 6 7 8}

How is the YCWS App treatment for sickle cell disease different from other treatments?

The YCWS App is unique because it combines self-monitoring of pain, stress, and opioid use with alerts and reminders, providing a digital tool for patients to manage their symptoms actively. Unlike traditional treatments that may focus solely on medication, this app empowers patients with real-time tracking and support, potentially reducing unplanned healthcare visits. ^{2 5 9 10 11}

Research Team

Miriam Ezenwa, PhD, RN, FAAN

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for English-speaking adults over 18 with Sickle Cell Disease (SCD) who experience moderate to severe pain and use opioids. It's not for those who are legally blind, physically unable to complete the study tasks, or have been in a related feasibility study before.

Inclusion Criteria

Speaks and reads English

I have experienced pain level above 3 due to SCD in the last 24 hours.

I have been diagnosed with sickle cell disease.

Exclusion Criteria

I am legally blind.

I cannot physically undergo the procedures required.

Previously participated in our relaxation/distraction intervention feasibility study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Short-term Treatment

Participants monitor stress, pain, and opioid use daily with system-generated alerts/reminders and intervention support for the experimental group

8 weeks

Daily self-monitoring

Long-term Treatment

Continued daily monitoring of stress, pain, and opioid use with system-generated alerts/reminders

3-6 months

Daily self-monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Self-monitoring of pain, stress, and opioid use + alerts/reminders
• You Cope, We Support (YCWS)

Trial Overview The trial tests a mobile health app that helps manage stress and pain through self-monitoring and provides relaxation/distraction exercises called 'You Cope, We Support' (YCWS). Participants will either use the full YCWS program or just self-monitor with alerts/reminders.

Participant Groups

Group I: Experimental Group Experimental Treatment 1 Intervention

(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.

Group II: Control Group Active Control 1 Intervention

(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.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Findings from Research

The mobile health platform Manage My Pain was well-accepted by patients at the Transitional Pain Service, with 67% of participants consenting to use it and 61% completing registration, indicating its potential as a valuable tool for pain self-management.

User retention rates were promising, with 67.9% of users continuing to engage with the app after 30 days and 43.2% after 90 days, suggesting that the app effectively supports ongoing pain monitoring and communication with healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement with Manage My Pain mobile health application among patients at the Transitional Pain Service. Slepian, PM., Peng, M., Janmohamed, T., et al.[2022]

The SMART app demonstrated high feasibility for monitoring pain in sickle cell disease patients, with a median compliance rate of 75% over 28 days, indicating that patients found it useful for tracking their symptoms.

There was a strong correlation between pain severity reported by patients and their pain intensity measurements using the app, suggesting that SMART effectively captures the patients' experiences of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Feasibility of an mHealth Intervention for Monitoring and Managing Pain Symptoms in Sickle Cell Disease: The Sickle Cell Disease Mobile Application to Record Symptoms via Technology (SMART). Jonassaint, CR., Shah, N., Jonassaint, J., et al.[2022]

The Prescription Opioid Documentation and Surveillance (PODS) System effectively collects comprehensive patient data, including pain intensity and addiction history, from 1,400 patients over 39 months, aiding physicians in evaluating patients before prescribing opioids.

PODS not only facilitates systematic patient evaluation but also generates an opioid agreement and provides legal documentation, which may enhance patient care and potentially reduce opioid abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Documenting and improving opioid treatment: the Prescription Opioid Documentation and Surveillance (PODS) System. Wilsey, BL., Fishman, SM., Casamalhuapa, C., et al.[2015]

A study involving 19 patients with sickle cell disease showed that using a handheld electronic device for pain management led to high participation and satisfaction rates over an 8-week period.

The device effectively monitored daily pain experiences and the practice of cognitive-behavioral coping skills, suggesting that wireless technology can enhance symptom tracking and communication between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of handheld wireless technology for a home-based sickle cell pain management protocol. McClellan, CB., Schatz, JC., Puffer, E., et al.[2022]

Children and adolescents with sickle cell disease (SCD) successfully used smartphones to access a web-based e-Diary, achieving at least 80% accuracy in reporting symptoms compared to traditional paper-based measures.

The e-Diary facilitated timely self-reporting of symptoms, which could enhance communication with healthcare providers and improve pain and symptom management for young patients with SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability testing of a Smartphone for accessing a web-based e-diary for self-monitoring of pain and symptoms in sickle cell disease. Jacob, E., Stinson, J., Duran, J., et al.[2021]

The OpPill application was developed to enhance opioid adherence among patients with sickle cell disease (SCD) and was rated highly by users for its engagement, functionality, aesthetics, and information quality, indicating its potential effectiveness in monitoring opioid use.

In a study with 28 participants, 91.7% found the app relevant to their care, and 85.7% reported it as interesting to use, suggesting that mobile health technology can be a feasible and user-friendly tool for managing opioid adherence in chronic pain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Quality Validation of a Mobile Application for Enhancing Adherence to Opioids in Sickle Cell Disease. Sop, DM., Crouch, T., Zhang, Y., et al.[2022]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

The COMM-9 is a newly developed, brief electronic version of the Current Opioid Misuse Measure (COMM) that effectively identifies aberrant opioid-related behavior in chronic pain patients, maintaining high classification accuracy similar to the full 17-item COMM.

In a study of 517 patients, the COMM-9 demonstrated strong test-retest reliability and successfully classified patients into risk categories for opioid misuse, making it a practical tool for clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Brief Version of the Current Opioid Misuse Measure (COMM): The COMM-9. McCaffrey, SA., Black, RA., Villapiano, AJ., et al.[2019]

The iCanCope with SCD program, a digital pain self-management platform for youth with sickle cell disease (SCD) and their caregivers, showed that 70% of youth engaged with the program, primarily using the mobile app for its ease of use and interactivity.

There was a moderate positive association between caregiver and child engagement, indicating that when caregivers are involved, youth are more likely to engage with the program, although many caregivers reported barriers to participation such as time constraints and perceived irrelevance of content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing User Engagement With a Digital Intervention for Pain Self-management Among Youth With Sickle Cell Disease and Their Caregivers: Subanalysis of a Randomized Controlled Trial. Lalloo, C., Nishat, F., Zempsky, W., et al.[2022]

The iCanCope program is a new smartphone and web-based intervention designed to help 160 adolescents with sickle cell disease manage their pain through personalized cognitive-behavioral therapy (CBT) techniques, including coping skills and social support.

This randomized controlled trial aims to assess the effectiveness of iCanCope in improving pain management and health-related quality of life over 12 weeks and at 6 months, addressing the significant barriers to accessing traditional CBT interventions for youth with SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iCanCope with Sickle Cell Pain: Design of a randomized controlled trial of a smartphone and web-based pain self-management program for youth with sickle cell disease. Palermo, TM., Zempsky, WT., Dampier, CD., et al.[2019]

The study enrolled 37 participants with sickle cell disease over 6 months, successfully using electronic patient-reported outcomes (ePRO) and actigraphy to monitor pain and activity, revealing significant changes in pain and functionality on days with vaso-occlusive crises (VOCs).

Biomarkers collected during VOCs showed significant alterations compared to baseline values, indicating that these biological changes could help in identifying and assessing VOCs more effectively in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by patient-reported outcomes, actigraphy, and biomarkers. Pittman, DD., Hines, PC., Beidler, D., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Engagement with Manage My Pain mobile health application among patients at the Transitional Pain Service. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Usability and Feasibility of an mHealth Intervention for Monitoring and Managing Pain Symptoms in Sickle Cell Disease: The Sickle Cell Disease Mobile Application to Record Symptoms via Technology (SMART). [2022]

3. England pubmed.ncbi.nlm.nih.gov

Documenting and improving opioid treatment: the Prescription Opioid Documentation and Surveillance (PODS) System. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

Use of handheld wireless technology for a home-based sickle cell pain management protocol. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Usability testing of a Smartphone for accessing a web-based e-diary for self-monitoring of pain and symptoms in sickle cell disease. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Quality Validation of a Mobile Application for Enhancing Adherence to Opioids in Sickle Cell Disease. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Development of a Brief Version of the Current Opioid Misuse Measure (COMM): The COMM-9. [2019]

9. Canada pubmed.ncbi.nlm.nih.gov

Characterizing User Engagement With a Digital Intervention for Pain Self-management Among Youth With Sickle Cell Disease and Their Caregivers: Subanalysis of a Randomized Controlled Trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

iCanCope with Sickle Cell Pain: Design of a randomized controlled trial of a smartphone and web-based pain self-management program for youth with sickle cell disease. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by patient-reported outcomes, actigraphy, and biomarkers. [2021]