Ignite Creation Date:
2024-05-06 @ 2:59 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04484272
Status:
RECRUITING
Last Update Posted:
2024-03-29
First Post:
2020-07-21
Brief Title:
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 relaxationdistraction 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 alertsreminders and 85 to Experimental Self-monitoring of outcomes alertsreminders use of YCWS RDE Support We will ask participants to report outcomes daily During weeks 1-8 we will send system-generated alertsreminders 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 himher 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 eg self-efficacy sex education family income computer experience etc and environmental characteristics eg distance from care quality of cell connection etc
Detailed Description:
Design The study is a RCT of the short-term 8 weeks and long-term 6 months effects of YCWS on efficacy outcomes pain stress and opioid use We will stratify patients on worst pain intensity 5 5 and randomly assign 170 adult outpatients to Control or Experimental groups The Aim 3 analysis is exploratory to understand predictors of intervention effects
Setting and Sample The University of Florida UF will be the site for data collection intervention delivery and data analysis Together the UF Health Shands Hospital Pediatric and Adult sickle cell programs have a clinic panel of 700 400 pediatric and 300 adult patients with SCD The available panel for this study is 403 patients with SCD 300 from the adult program and from the pediatric program 47 who currently are 18 years old and have not yet transitioned to adult care and 56 who will become adults during our study period We will use Internet and remote technologies which will allow subjects to complete the study in their setting of choice where Internet service is available We will also load some of the video clips on patients mobile devices for use when the internet is not available For those who meet the eligibility criteria we anticipate enrolling 195 subjects in order to retain 170 subjects with complete data at 8 weeks based on a 13 attrition rate and approximately the rate observed in our previous longitudinal studies in which follow-up was more than a year15 Randomization Using our groups randomization software we will use permuted block randomization with stratification based on worst pain intensity 5 5 We will randomly assign the 195 consecutively selected patients to the two study groups Assignment will be unknown until a sealed electronic envelope is opened after a patient completes pretest data collection procedures
Procedures After introduction by clinic staff the research specialist RS will approach patients during their outpatient clinic visits inpatient hospitalization or by phone or e-mail for those registered in the UF SCD research registry The RS will explain the study and ascertain their willingness to participate The RS will inform patients that participation is voluntary and a decision to decline participation will not affect their care For patients choosing to participate the RS will ask them to sign a written consent at the time of recruitment or on the day of the first study visit The RS will contact the patients the day before the study visit as a reminder for the upcoming visit After informed consent patients will complete baseline measures and be randomly assigned to Experimental or Control groups Figure 3 The RS will provide standardized instruction on how to use the study Galaxy tablet or their personal mobile device for daily study procedures at home focusing on alertsreminders daily data entry and customization of YCWS app via settings panel Tolerable and optimal pain goal time of day to complete study activities etc For the short-term trial the first 8 weeks all patients will monitor their stress pain and opioid use daily and get automated system-generated alertsreminders every 24 hours via phone call text or email to facilitate data entry Patients in the experimental group also will receive intervention support Goal-setting action planning decision-making and problem solving related to YCWS intervention use If the patient does not enter data after 24 hours study support staff will contact himher for data entry trouble-shooting both groups and YCWS use experimental We will conduct an audio-recorded exit interview to explore barriers patients encountered using mobile devices for the intervention and for data collection and acceptability of system-generated support We will ask patients if they used the acute care center emergency department or were admitted to the hospital during our study period verified by electronic chart review For the long-term trial months 3-6 patients in the experimental group will continue to have access to the banks of video links and will continue monitoring stress pain and opioid use daily with only system-generated alertsreminders every 24 hours if patient did not enter data Patients in the control group also will continue monitoring stress pain and opioid use daily with system-generated alertsreminders every 24 hours We will also collect system-based daily activities during months 3-6
Intervention Experimental Self-monitoring of pain stress and opioid use alertsreminders 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 Table 1 When patients click on self-monitoring stress intensity scale 0-10 and pain intensity scale 0-10 subtabs will display on the screen consecutively Patients will touch the screen to record their stress and pain intensity Once patients record their stress or pain intensity they will receive instantaneous feedback via graphical readout showing their stress and pain during the past week including the present day their pain goals and their daily YCWS use An auxiliary icon under self-monitoring is Goal Setting Patient can use this auxiliary icon to revise optimal and tolerable pain goals time of day to complete study activities including support and setting alertsreminders When patients click video banks three sub-icons basic every-day and favorite will display Patients can click any of the three banks to choose a specific video to watch Patients can watch as many video clips as needed Per patient preference we will send system-generated alertsreminders every 24 hours to patients via phone call text or email to facilitate data entry and intervention use Patient clicking getting support tab also will open sub-tabs report issue chat text call talk FaceTime email Patient can connect with our support staff about issues related to YCWS intervention use experimental group only technical difficulty with study device or app for advice on what to do both groups Our support staff also will monitor our database daily If the patient does not enter data after 24 hours after system-generated alertsreminders study support staff will contact himher for data entry trouble-shooting and for the experimental group on YCWS use as they indicated in their goals
During the short-term trial Weeks 1-8 patients will monitor their stress and pain daily as described above We will provide experimental group patients access to three video banks from which to choose their daily intervention Patients will use only basic videos in Week 1 to get familiar with the intervention and learn deep breathing relaxation exercise through instructions During weeks 1-8 we will send automated system-generated alertsreminders every 24 hours to experimental group patients via phone call text or email to facilitate intervention use If the patient does not enter data after 24 hours study support staff who will be from the community will contact himher 2 hours prior to the next data collection time for trouble-shooting This support staff will contact patients via chat text phone call or FaceTime based on patients preferences to facilitate participation and trouble-shoot
During the long-term period months 3-6 only system-generated alertsreminders will be available Patients will have the ability to find their favorite video clips online and add them to the favorite videos for personal use and recommend them via the investigators to other patients with SCD We will vet these recommendations before releasing them to other patients Throughout the study period we will time stamp and track patients YCWS online activities to capture data on system usage and pain and stress intensity
Control Self-monitoring of pain stress and opioid use alertsreminders During efficacy trial Weeks 1-8 just like patients in the experimental group patients will monitor their stress pain and opioid use daily We will send system-generated alertsreminders every 24 hours to patients via phone call text or email to facilitate data entry If the patient does not enter data after 24 hours after alertsreminders study support staff will contact himher for data entry trouble-shooting During the long-term period months 3-6 patients will continue to monitor their stress pain and opioid use daily Patients also will continue to receive only system-generated alertsreminders Throughout the study period we will time stamp and track patients online activities to capture data on system use and pain and stress intensity
Outcome Measures stress and pain 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
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
Opioid use We will use PAINReportIt87-89 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 track opioid refills through patients pharmacy We will use Wisepill medication event monitoring system MEMS to collect data on opioid use
Statistical Analysis Dr Yao a co-I and the study biostatistician will conduct the data management and data analysis procedures in collaboration with the PI and co-Is The data will be stored in a SQL database and will be exported to statistical software R for analysis We will utilize an intention to treat approach where all randomized subjects will be included in our analysis
Every effort will be taken in our software design to reduce user errors all data will be entered directly by the subject using an interface tested with cognitive interview methods that informed the final interface design Consistency checks are built into the software so that inconsistent data eg out of range or logically inconsistent are flagged immediately for clarification from the users In addition more comprehensive consistency checks will be performed before data analysis Inconsistent data points will be treated as missing Based on our prior studies with this web application we expect the percentage of inconsistent data values to be very low 05
For missing data including those caused by subjects missing visits multiple imputation will be used to generate multiple completed datasets on which statistical inference will be performed and then aggregated Missing at random assumption will be assessed and if necessary sensitivity analysis will be performed using the pattern mixture model Specifically we will test various plausible selective missing mechanisms through post-processing of imputations to evaluate the robustness of our findings We will consider a p value lower than 0025 as statistically significant for tests of intervention efficacy short term and long term on the primary outcome of pain intensity For other inferences we will consider a p value lower than 005 to be statistically significant
We will compute descriptive statistics frequencies means standard deviations etc of baseline patient characteristics data which include demographic data and the patients pain stress and analgesic use at pretest and compare the control group and the experimental group using chi-squared tests or t-tests We expect no significant difference between the two randomly generated groups
Setting and Sample The University of Florida UF will be the site for data collection intervention delivery and data analysis Together the UF Health Shands Hospital Pediatric and Adult sickle cell programs have a clinic panel of 700 400 pediatric and 300 adult patients with SCD The available panel for this study is 403 patients with SCD 300 from the adult program and from the pediatric program 47 who currently are 18 years old and have not yet transitioned to adult care and 56 who will become adults during our study period We will use Internet and remote technologies which will allow subjects to complete the study in their setting of choice where Internet service is available We will also load some of the video clips on patients mobile devices for use when the internet is not available For those who meet the eligibility criteria we anticipate enrolling 195 subjects in order to retain 170 subjects with complete data at 8 weeks based on a 13 attrition rate and approximately the rate observed in our previous longitudinal studies in which follow-up was more than a year15 Randomization Using our groups randomization software we will use permuted block randomization with stratification based on worst pain intensity 5 5 We will randomly assign the 195 consecutively selected patients to the two study groups Assignment will be unknown until a sealed electronic envelope is opened after a patient completes pretest data collection procedures
Procedures After introduction by clinic staff the research specialist RS will approach patients during their outpatient clinic visits inpatient hospitalization or by phone or e-mail for those registered in the UF SCD research registry The RS will explain the study and ascertain their willingness to participate The RS will inform patients that participation is voluntary and a decision to decline participation will not affect their care For patients choosing to participate the RS will ask them to sign a written consent at the time of recruitment or on the day of the first study visit The RS will contact the patients the day before the study visit as a reminder for the upcoming visit After informed consent patients will complete baseline measures and be randomly assigned to Experimental or Control groups Figure 3 The RS will provide standardized instruction on how to use the study Galaxy tablet or their personal mobile device for daily study procedures at home focusing on alertsreminders daily data entry and customization of YCWS app via settings panel Tolerable and optimal pain goal time of day to complete study activities etc For the short-term trial the first 8 weeks all patients will monitor their stress pain and opioid use daily and get automated system-generated alertsreminders every 24 hours via phone call text or email to facilitate data entry Patients in the experimental group also will receive intervention support Goal-setting action planning decision-making and problem solving related to YCWS intervention use If the patient does not enter data after 24 hours study support staff will contact himher for data entry trouble-shooting both groups and YCWS use experimental We will conduct an audio-recorded exit interview to explore barriers patients encountered using mobile devices for the intervention and for data collection and acceptability of system-generated support We will ask patients if they used the acute care center emergency department or were admitted to the hospital during our study period verified by electronic chart review For the long-term trial months 3-6 patients in the experimental group will continue to have access to the banks of video links and will continue monitoring stress pain and opioid use daily with only system-generated alertsreminders every 24 hours if patient did not enter data Patients in the control group also will continue monitoring stress pain and opioid use daily with system-generated alertsreminders every 24 hours We will also collect system-based daily activities during months 3-6
Intervention Experimental Self-monitoring of pain stress and opioid use alertsreminders 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 Table 1 When patients click on self-monitoring stress intensity scale 0-10 and pain intensity scale 0-10 subtabs will display on the screen consecutively Patients will touch the screen to record their stress and pain intensity Once patients record their stress or pain intensity they will receive instantaneous feedback via graphical readout showing their stress and pain during the past week including the present day their pain goals and their daily YCWS use An auxiliary icon under self-monitoring is Goal Setting Patient can use this auxiliary icon to revise optimal and tolerable pain goals time of day to complete study activities including support and setting alertsreminders When patients click video banks three sub-icons basic every-day and favorite will display Patients can click any of the three banks to choose a specific video to watch Patients can watch as many video clips as needed Per patient preference we will send system-generated alertsreminders every 24 hours to patients via phone call text or email to facilitate data entry and intervention use Patient clicking getting support tab also will open sub-tabs report issue chat text call talk FaceTime email Patient can connect with our support staff about issues related to YCWS intervention use experimental group only technical difficulty with study device or app for advice on what to do both groups Our support staff also will monitor our database daily If the patient does not enter data after 24 hours after system-generated alertsreminders study support staff will contact himher for data entry trouble-shooting and for the experimental group on YCWS use as they indicated in their goals
During the short-term trial Weeks 1-8 patients will monitor their stress and pain daily as described above We will provide experimental group patients access to three video banks from which to choose their daily intervention Patients will use only basic videos in Week 1 to get familiar with the intervention and learn deep breathing relaxation exercise through instructions During weeks 1-8 we will send automated system-generated alertsreminders every 24 hours to experimental group patients via phone call text or email to facilitate intervention use If the patient does not enter data after 24 hours study support staff who will be from the community will contact himher 2 hours prior to the next data collection time for trouble-shooting This support staff will contact patients via chat text phone call or FaceTime based on patients preferences to facilitate participation and trouble-shoot
During the long-term period months 3-6 only system-generated alertsreminders will be available Patients will have the ability to find their favorite video clips online and add them to the favorite videos for personal use and recommend them via the investigators to other patients with SCD We will vet these recommendations before releasing them to other patients Throughout the study period we will time stamp and track patients YCWS online activities to capture data on system usage and pain and stress intensity
Control Self-monitoring of pain stress and opioid use alertsreminders During efficacy trial Weeks 1-8 just like patients in the experimental group patients will monitor their stress pain and opioid use daily We will send system-generated alertsreminders every 24 hours to patients via phone call text or email to facilitate data entry If the patient does not enter data after 24 hours after alertsreminders study support staff will contact himher for data entry trouble-shooting During the long-term period months 3-6 patients will continue to monitor their stress pain and opioid use daily Patients also will continue to receive only system-generated alertsreminders Throughout the study period we will time stamp and track patients online activities to capture data on system use and pain and stress intensity
Outcome Measures stress and pain 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
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
Opioid use We will use PAINReportIt87-89 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 track opioid refills through patients pharmacy We will use Wisepill medication event monitoring system MEMS to collect data on opioid use
Statistical Analysis Dr Yao a co-I and the study biostatistician will conduct the data management and data analysis procedures in collaboration with the PI and co-Is The data will be stored in a SQL database and will be exported to statistical software R for analysis We will utilize an intention to treat approach where all randomized subjects will be included in our analysis
Every effort will be taken in our software design to reduce user errors all data will be entered directly by the subject using an interface tested with cognitive interview methods that informed the final interface design Consistency checks are built into the software so that inconsistent data eg out of range or logically inconsistent are flagged immediately for clarification from the users In addition more comprehensive consistency checks will be performed before data analysis Inconsistent data points will be treated as missing Based on our prior studies with this web application we expect the percentage of inconsistent data values to be very low 05
For missing data including those caused by subjects missing visits multiple imputation will be used to generate multiple completed datasets on which statistical inference will be performed and then aggregated Missing at random assumption will be assessed and if necessary sensitivity analysis will be performed using the pattern mixture model Specifically we will test various plausible selective missing mechanisms through post-processing of imputations to evaluate the robustness of our findings We will consider a p value lower than 0025 as statistically significant for tests of intervention efficacy short term and long term on the primary outcome of pain intensity For other inferences we will consider a p value lower than 005 to be statistically significant
We will compute descriptive statistics frequencies means standard deviations etc of baseline patient characteristics data which include demographic data and the patients pain stress and analgesic use at pretest and compare the control group and the experimental group using chi-squared tests or t-tests We expect no significant difference between the two randomly generated groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PRO00028515 | OTHER | UFIRST | httpsreporternihgovquickSearch5R01NR018848-03 |
| 5R01NR018848-03 | NIH | None | None |