YCWS App for Sickle Cell Disease
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Florida
Must be taking: Opioid analgesics
Disqualifiers: Legally blind, physically unable, others
No Placebo Group
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.
12345Is 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.
12678How 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.
2591011Eligibility 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.
+2 more
Exclusion Criteria
I am legally blind.
I cannot physically undergo the procedures required.
Previously participated in our relaxation/distraction intervention feasibility study
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental GroupExperimental Treatment1 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 GroupActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
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Who Is Running the Clinical Trial?
University of FloridaLead Sponsor
National Institute of Nursing Research (NINR)Collaborator
References
Engagement with Manage My Pain mobile health application among patients at the Transitional Pain Service. [2022]Mobile health platforms have become an important component of pain self-management programs and hundreds of mobile applications are commercially available for patients to monitor pain. However, few of these applications have been developed in collaboration with healthcare professionals or have been critically evaluated. Manage My Pain is a user-driven mobile health platform developed by ManagingLife in collaboration with clinician researchers. Manage My Pain allows patients to keep a "pain record" and supports communication of this information with clinicians. The current report describes a user engagement study of Manage My Pain among patients at the Transitional Pain Service (TPS) at Toronto General Hospital, a multidisciplinary clinic for patients at high risk of developing postsurgical pain.
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]Patients with sickle cell disease frequently experience severe pain events that lead to unplanned healthcare utilization. Mobile health tools (mHealth) may help prevent these events by providing remote monitoring and self-management support. This article describes the feasibility of the Sickle cell disease Mobile Application to Record symptoms via Technology (SMART), an mHealth app developed to help sickle cell disease patients monitor and manage their day-to-day symptoms. Fifteen patients recorded their pain intensity using a paper visual analog scale (VAS) and then repeated this measurement using an electronic VAS pain measure on SMART. Patients continued using SMART to record clinical symptoms, pain intensity, location and perceived severity, and treatment strategies for at least 28 days. Patient median age was 29 years (range 16-54); 60.0% were male. There was a high intraclass correlation between pain measurements entered on the paper VAS and SMART on the iPhone and the iPad We found a strong association between patient perceived pain severity and pain intensity entries using SMART (b = 1.71; p
Documenting and improving opioid treatment: the Prescription Opioid Documentation and Surveillance (PODS) System. [2015]To demonstrate that a computer-assisted survey instrument offers an efficient means of patient evaluation when initiating opioid therapy. Design. We report on our experience with the Prescription Opioid Documentation and Surveillance (PODS) System, a medical informatics tool that uses validated questionnaires to collect comprehensive clinical and behavioral information from patients with chronic pain.
Use of handheld wireless technology for a home-based sickle cell pain management protocol. [2022]To evaluate use of a handheld electronic wireless device to implement a pain management protocol for participants with sickle cell disease (SCD).
Usability testing of a Smartphone for accessing a web-based e-diary for self-monitoring of pain and symptoms in sickle cell disease. [2021]We examined the usability of smartphones for accessing a web-based e-Diary for self-monitoring symptoms in children and adolescents with sickle cell disease (SCD). One group of participants (n = 10; mean age, 13.1 ± 2.4 y; 5 M; 5 F) responded to questions using precompleted paper-based measures. A second group (n = 21; mean age, 13.4 ± 2.4 y; 10 M; 11 F) responded based on pain and symptoms they experienced over the previous 12 hours. The e-Diary was completed with at least 80% accuracy when compared to paper-based measures. Symptoms experienced over the previous 12 hours included feeling tired (33.3%), headache (28.6%), coughing (23.8%), lack of energy/fatigue (19.0%), yellowing of the eyes (19.0%), pallor (19.0%), irritability (19.0%), stiffness in joints (19.0%), general weakness (14.3%), and pain (14.3%), rating on average as 2.0 ± 1.7 (on 0 to 10 scale). Overall, sleep was good (8.1 ± 1.4 on the 0 to 10 scale). In conclusion, children with SCD were able to use smartphones to access a web-based e-Diary for reporting pain and symptoms. Smartphones may improve self-reporting of symptoms and communication between patients and their health care providers, who may consequently be able to improve pain and symptom management in children and adolescents with SCD in a timely manner.
Feasibility and Quality Validation of a Mobile Application for Enhancing Adherence to Opioids in Sickle Cell Disease. [2022]Prescription opioid nonadherence, specifically opioid misuse, has contributed to the opioid epidemic and opioid-related mortality in the US. Popular methods to measure and control opioid adherence have limitations, but mobile health, specifically smartphone applications, offers a potentially useful technology for this purpose. We developed, tested, and validated the OpPill application using the Mobile Applications Rating Scale (MARS), a validated tool for assessing the quality of mobile health apps. The MARS contains four scales (range of each scale = 0-4) that rate Engagement, Functionality, Aesthetics, and Information Quality. It also assesses subjective quality, relevance, and overall application impact. Our application was built to be a mobile monitoring and reporting system intended to enhance opioid adherence by collecting data and providing systematic feedback on pain and opioid use. Patients (n = 28) all had one of various SCD genotypes, were ages 19 to 59 years (mean 36.56), 53.6% were female, and 39.3% had completed some college. Patients rated the OpPill application highly on all four scales: Engagement, 3.93 ± 0.73; Functionality, 4.54 ± 0.66; Aesthetics, 3.92 ± 0.81; Information, 3.91 ± 0.87. The majority of patients found the application to be relevant for their care. A total of 96% reported the information within the app was complete, while 4% estimated the information to be minimal or overwhelming. Patients (91.7%) overwhelmingly reported that the quality of information as it pertained to SCD patients was relevant; only 8.3% found the application to be poorly relevant to SCD. Similarly, patients (91.7%) overwhelmingly rated both the application's performance and ease of use positively. The large majority of participants (85.7%) found the application to be interesting to use, while 74% found it entertaining. All users found the application's navigation to be logical and accurate with consistent and intuitive gestural design. We conclude that the OpPill application, specifically targeted to monitor opioid use and pain and opioid behavior in patients with Chronic Non-Cancer Pain, was feasible and rated by SCD patients as easy-to-use using a validated rating tool.
Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]To describe the development of an interactive, web-based self-management intervention for opioid-treated, chronic pain patients with aberrant drug-related behavior.
Development of a Brief Version of the Current Opioid Misuse Measure (COMM): The COMM-9. [2019]The Current Opioid Misuse Measure (COMM) is a commonly used self-report instrument to identify and monitor aberrant opioid-related behavior in chronic pain patients on opioid therapy. However, the length of the COMM may limit its clinical utility. Additionally, this paper-and-pencil screener requires hand scoring, which increases paperwork and staff burden. Therefore, the current study presents development of the "COMM-9," a brief electronically administered form of the COMM.
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]Sickle cell disease (SCD) is characterized by severe acute pain episodes as well as risk for chronic pain. Digital delivery of SCD pain self-management support may enhance pain self-management skills and accessibility for youth. However, little is known about how youth with SCD and their caregivers engage with digital health programs. iCanCope with pain is a digital pain self-management platform adapted for youth with SCD and caregivers through a user-centered design approach. The program was delivered via a website (separate versions for youth and caregiver) and mobile app (youth only).
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]Many adolescents with sickle cell disease (SCD) experience recurrent and chronic pain, which has a negative impact on their health-related quality of life (HRQL). Cognitive-behavioral therapy (CBT) interventions can lead to improvement in pain and HRQL, yet due to barriers to care, most youth with SCD will not receive these interventions. To address this need for innovative programs targeting youth with SCD pain, we developed iCanCope, a tailored smartphone and web-based program that delivers a pain self-management intervention to youth with SCD. We describe the rationale, design, and implementation of a three-site parallel group randomized controlled trial with a sample of 160 adolescents with SCD and their parent caregivers. The iCanCope program includes pain self-management skills training (personalized CBT-based coping skills such as deep breathing, relaxation, and cognitive skills), goal setting, and social support. The attention control group is provided with access to a self-guided website with education about SCD. Assessments will occur at baseline (T1), immediately after completion of the intervention (12 weeks; T2) and at 6 months post-intervention (T3). Primary outcomes include coping strategies and pain intensity; secondary outcomes include physical, social, and emotional functioning, treatment satisfaction, health service use and caregiver response to youth pain behavior. Potential mediators (goal setting, self-management, and perceptions of social support) and moderators (e.g., demographic factors) will also be tested. The objective is to offer an effective, convenient, and low-cost psychosocial intervention to youth with SCD to enhance their self-management of pain.
Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) by patient-reported outcomes, actigraphy, and biomarkers. [2021]Clinical trials in sickle cell disease (SCD) often focus on health care utilization for painful vaso-occlusive crises (VOCs). However, no objective, quantifiable pain biomarkers exist, pain is not specific to VOCs, health care utilization varies between patients, unreported at-home VOCs likely contribute to long-term outcomes, and patient-reported outcomes are seldom considered. This noninterventional, longitudinal, 6-month study aimed to develop tools to identify VOCs in SCD patients with or without health care utilization. Participants wore an actigraph device, tracking sleep and activity. Patients with SCD used an electronic patient-reported outcome (ePRO) tool to collect data on pain, medication, fatigue, and daily function. Patients self-reported when they experienced VOC pain (VOC day). Biomarkers were collected every 3 weeks (non-VOC). Self-reported VOCs triggered at-home or in-hospital blood collection. The study enrolled 37 participants with SCD; 35 completed the study. Participants reported 114 VOC events and 346 VOC days, of which 62.3% and 78.3%, respectively, were self-treated at home. The ePRO and actigraphy captured end points of pain, functionality, fatigue, activity, and sleep; each was significantly altered on VOC days compared with non-VOC days. Biomarkers collected at home or in the hospital on VOC days were significantly altered compared with non-VOC baseline values, including leukocyte-platelet aggregates, microfluidic-based blood cell adhesion, interleukin-6, C-reactive protein, interleukin-10, tumor necrosis factor-α, and thrombin-antithrombin. The Evaluation of Longitudinal Pain Study in Sickle Cell Disease (ELIPSIS) trial shows the feasibility of accurately monitoring out-of-hospital pain by using patient-reported VOC days as potential end points for clinical trials in SCD; it describes the changes in biomarkers and activity measured by actigraphy that may enable improved identification and assessment of VOCs.