Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease

Study Overview
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Brief Summary
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This project will evaluate AppliedVR's EaseVRx - a multi-modal, skills-based, 8-week, virtual reality, home intervention - in an exploratory randomized controlled trial for self-management of chronic pain among Black, young adults (ages 18-50) with sickle cell disease.

Detailed Description
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Chronic pain in sickle cell disease (SCD) is a major health problem. Because of the high pain burden associated with SCD and the existing health disparities in comprehensive pain management, non-pharmacological, home-based strategies are urgently needed to help manage chronic pain. In this study, the investigators will use a single-site, 8-week, randomized clinical trial (with follow-up at 12 weeks) to evaluate a home-based, pain self-management program for chronic pain in Black adults with SCD. Study participants will be identified from the group of patients with chronic pain who receive care in the SCD clinic of the Georgia Comprehensive Sickle Cell Center at Grady Memorial Hospital (Grady) in Atlanta, Georgia. Patients may be recommended by the Center's staff or may self-identify in response to study flyers posted in the Center, health facilities or community-based organizations in surrounding areas, or on social media. Recruitment and consent will take place in a private area of the SCD clinic, the research center in the Nell Hodgson Woodruff School of Nursing at Emory University, or remotely if necessary. Consent may also occur remotely if necessary. After enrollment, in-person study activities will take place in the SCD clinic or the research center while remote study activities will take place in participants' homes on their own time. Participants will complete questionnaires and a pain diary, use the pain management program at home (delivered with a virtual reality device or audio only on SoundCloud), and complete a qualitative interview or focus group session. Compensation will be provided after completion of each of these study activities. During the study, subjects will continue their standard pain management routine, including any pain medications, as prescribed by their healthcare provider. This research will advance both scientific knowledge and human health by focusing on addressing unmet needs for an underserved population. This study is the first randomized clinical trial that investigates a virtual reality, home-based pain self-management program for chronic pain in adults with SCD. Therefore, this study represents the first essential step in developing a culturally-tailored, non-pharmacological, home-based, chronic pain self-management intervention specifically for Black adults with SCD that can be used along with standard SCD care.

Official Title
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Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease (HIPAS)

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Device: EaseVRx
* Behavioral: Audio-only version of EaseVRx


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Black adults, ages 18-50 years; diagnosis of SCD (Sickle cell disease); chronic non vaso-occlusive pain experienced > 3 days per week on average for > 6 months; ability to wear a VR (Virtual reality) head-mounted display and move head in cervical rotation, extension, and flexion; sufficient fine motor control to operate VR equipment such as a controller; and ability to read, write, and understand English. Exclusion Criteria: 1. Conditions: Co-morbidities that may influence pain perception; diagnosis of epilepsy or susceptibility to seizures, migraines, or other neurological disorders that may prevent VR use, and/or other medical conditions due to which individuals are predisposed to nausea and dizziness; susceptibility to claustrophobia, motion sickness or cybersickness (digital motion sickness); history of blackouts; hypersensitivity to flashing lights or motion; lack of stereoscopic vision; severe visual or hearing impairment; inability to operate VR equipment (such as inability to turn head or use hands to operate external controller); and/or injury to the eyes, face, head, or neck that prevents comfortable VR use. 2. Other exclusions: Medical instability as determined by healthcare providers at the study site; significant motor impairment; surgery within the last three months; planning to start a new pain management strategy (such as medication, physiotherapy, acupuncture, or cognitive behavioral therapy) in the next three months; history of major psychiatric disorder (such as schizophrenia or bipolar disorder) not controlled with medication or behavioral factors that would interfere with study procedures; alcohol or substance dependence, heart conditions, or the presence of implanted medical devices (such as cardiac pacemakers) as noted in the electronic health record; cognitive or developmental disabilities; active suicidal ideation; inability to read, write, or understand English; pregnancy; and/or plans for vacation in the next three months. This study will not include any of these special populations: Adults unable to consent Individuals who are not yet adults (infants, children, teenagers) Pregnant women Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EaseVRx Group<br>Participants will be asked to complete the 8-week program with assigned modules each week. Each week, participants will be asked to complete 7 modules, averaging 5 minutes in duration and ranging from 2 to 16 minutes in duration, for a total of 56 modules across the program. Participants will be instructed not to use the device while ambulating, and that they should use the headset a maximum of 3 times per 24-hour period (morning, noon, and evening) for not more than 30 minutes consecutively. | Device: EaseVRx<br>* EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.<br>|
| Active Comparator: Active control Group<br>Participants in the control group will be asked to use the audio-only version of EaseVRx that excludes references to visual content. They will receive an electronic link to the audio recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer. Each week, participants will be asked to complete 7 audio sessions. | Behavioral: Audio-only version of EaseVRx<br>* Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain rating | Self-reported pain ratings will be assessed with the Numerical Pain Rating Scale (NPRS). On the NPRS, pain intensity levels range from 0 to 10 (0 = no pain and 10 = worst pain). Lower pain ratings correlate with better outcome. | Baseline, daily during treatment (8 weeks), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in participant engagement: minutes of program use per day | Minutes of daily program use may range from 2 minutes to 48 minutes or more. The investigator hypothesizes that higher usage will correlate with a better outcome. | Daily during treatment (8 weeks) | 
| Change in participant engagement: duration | Throughout the 8-week treatment period, device usage duration may range from 0 to 7 days each week. The investigator hypothesizes that higher usage will correlate with a better outcome. | Daily during treatment (8 weeks) | 
| Change in participant engagement: features utilized | Assessed by the number of features utilized when using the device. The number of features may range from 0 to 3. The investigator hypothesizes that use of a higher number of features will correlate with a better outcome. | Daily during treatment (8 weeks) | 
| Change in participant engagement: completion rates | Assessed by completion rates: the number of modules completed weekly. Rates may range from 0 to 7 modules completed each week. The investigator hypothesizes that completion of a higher number of modules weekly will correlate with a better outcome. | Daily during treatment (8 weeks) | 
| Change in Study Retention | Assessed by the actual number of days that participants completed all outcome assessments. Study retention may range from 0 to 7 days weekly. The investigator hypothesizes that higher study retention will correlate with a better outcome. | Baseline, during treatment (8 weeks), and post-treatment (up to 6 weeks post-treatment) | 
| Participant satisfaction | Assessed, once at the end of the program, via individual qualitative interviews or focus group sessions. Participants will be asked to evaluate the program by responding to the four items listed below, using a Likert scale (strongly agree, somewhat agree, somewhat disagree, strongly disagree) for the first three items and 1-10 (with 10 being definitely would recommend) for the fourth item.• The VR program was easy to use.• I enjoyed using the VR program.• The content in the VR program helped me cope with my pain.• On a scale of 1-10, how likely are you to recommend the VR program to someone else at this time? The investigator hypothesizes that responses of strongly agree and higher scores will correlate with a better outcome. | Post-treatment (up to 6 weeks post-treatment) | 
| Change in safety | Assessed by monitoring participants for the occurrence of adverse events. Fewer adverse events will correlate with a better outcome. | Daily during treatment (8 weeks) and monthly post-treatment (up to 6 weeks post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in chronic pain acceptance | Assessed by the Chronic Pain Acceptance Questionnaire (CPAQ-8) which measures acceptance of chronic pain. Items are scored on a scale from 0 to 6 (never true to always true), and higher scores (scores range from 0 to 48) indicate higher levels of acceptance (better outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in Chronic Pain Self-Efficacy | Assessed by using the Chronic Pain Self-Efficacy Scale (CPSES) which measures efficacy expectations for coping with the consequences of chronic pain. Items are scored on a 10-point Likert-type scale from 10 to 100 (very uncertain to very certain), and higher scores (scores range from 220 to 2200) indicate higher chronic pain self-efficacy (better outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in Social Support | Assessed by using the Social Support Questionnaire (SSQ) which measures perceptions of the desirability, availability, use, and usefulness of social support. Items are scored on a scale from 1 to 5 (not at all to very much, constantly), and higher scores (scores range from 8 to 40) indicate higher levels of social support (better outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in Pain Catastrophizing | Assessed by using the Pain Catastrophizing Scale (PCS-13) which measures thoughts and feelings when pain is experienced. Items are scored on a scale from 0 to 4 (not at all to all the time), and higher scores (scores range from 0 to 52) indicate a higher degree of catastrophizing (worse outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in BRIEF Health Literacy | Assessed by using the BRIEF Health Literacy Screening Tool which measures the amount of help needed in healthcare situations. Items are scored on a scale from 1 to 5 (always to never and not at all to extremely), and higher total scores (scores range from 4 to 20) indicate greater health literacy (better outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in executive function | Behavior Rating Inventory of Executive Function (BRIEF-A) which measures adult executive functioning/self-regulation. Items are scored on a scale from 1 to 7 (never a problem to always a problem) and higher total scores (scores range from 34 to 238) indicate more symptoms of executive dysfunction (worse outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in anxiety levels | Assessed by using PROMIS Emotional Distress - Anxiety which measures self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal. Items are scored on a 5-point Likert scale ranging from 1 to 5 (never to always). Higher T-scores (scores range from 55 to > 70) correlate with severe anxiety (worse outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in depression levels | Assessed by using PROMIS Emotional Distress - Depression which measures self-reported negative mood, views of self, social cognition, and decreased positive affect and engagement. Items are scored on a 5-point Likert scale ranging from 1 to 5 (never to always). Higher T-scores (scores range from 55 to > 70) correlate with severe depression (worse outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in Sleep | Assessed by the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Sleep Impact Short Form which measures sleep disturbances. 5 items are assessed using a scale that ranges from never to always. Higher T-scores (scores range from 55 to > 70) correlate with better self-reported health (better outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in Functional activities of daily living | Assessed by the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)Pain Impact Short Form which measures the effects of sickle cell pain on activities of daily living. 5 items are assessed using a scale that ranges from never to always. Higher T-scores (scores range from 55 to > 70) correlate with better self-reported health (better outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in disability | Assessed by the Chronic Pain Grade Questionnaire (CPGQ) which classifies individuals into one of four categories according to pain severity or interference. Items are scored on a scale from 0 to 10, with total scores for chronic pain intensity and chronic pain disability ranging from 0 to 100. Higher total scores indicate a higher level of disability that is severely limiting (worse outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in Healthcare utilization | Assessed by healthcare utilization for pain in the previous 12 months as reflected by number of visits in the electronic medical record. The number of healthcare visits may range from 0 to 20 or more. A higher number of visits is correlated with worse outcome. | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in use of pain medications | Assessed by prescription pain medications documented in the electronic medical record and self-reported use of over-the-counter analgesics. The number of pain medications may range from 0 to 20 or more. A higher number of pain medications correlates with a worse outcome. | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 
| Change in Quality of life | Assessed by the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) Short Forms: ASCQ-Me Pain Episodes Short Form which measures the frequency and severity of sickle cell pain episodes; ASCQ-Me Emotional Impact Short Form which measures the effects of sickle cell on emotional well-being; ASCQ-Me Social Functioning Short Form which measures the influence of health on social functioning, and ASCQ-Me Stiffness Impact Short Form which measures joint/body stiffness. For Pain Episodes: 5 items are assessed using a scale that varies across the items. Higher T-scores (scores range from 55 to > 70) correlate with worse self-reported health (worse outcome). For Emotional Impact, Social Functioning, and Stiffness: 5 items are assessed using a scale that ranges from never to always or not at all to very much. Higher T-scores (scores range from 55 to > 70) correlate with better self-reported health (better outcome). | Baseline, mid-treatment (week 4), and monthly post-treatment (up to 6 weeks post-treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain management, Virtual Reality Device