Clinical trial NCT04906707: Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease
Official title: Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease (HIPAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Pain management
Virtual Reality Device
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-05-28
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Rating Using Numerical Pain Rating Scale (NPRS)
timeFrame: Baseline, up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)
measure: Pain Intensity Subscale of the Chronic Pain Grade Questionnaire
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
measure: Participant Engagement: Minutes of Program Use Per Day
timeFrame: up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)
measure: Participant Engagement: Duration in Days
timeFrame: Baseline, daily during treatment (4 weeks or time period 1, day 1-28), daily during treatment (8 weeks or time period 2, days 29-56)
measure: Participant Engagement: Features Utilized
timeFrame: Daily during treatment (8 weeks)
measure: Participant Engagement: Completion Rates
timeFrame: Daily average during treatment (up to 8 weeks)
measure: Study Retention: Surveys
timeFrame: Baseline, 4 weeks, 8 weeks and 4 weeks post-intervention (week 12)
measure: Study Retention: Daily Diaries
timeFrame: Up to 8 weeks
measure: Participant Satisfaction
timeFrame: Post-treatment (up to 6 weeks post-treatment)
measure: Frequency of Highest Satisfaction Scores
timeFrame: Post-treatment (up to 6 weeks post-treatment)
measure: Safety: Number of Adverse Events
timeFrame: 4 weeks, 8 weeks, up to 6 weeks post-treatment
Secondary outcomes:
measure: Chronic Pain Acceptance Score
timeFrame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
measure: Chronic Pain Self-Efficacy
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)
measure: Social Support
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (12 weeks)
measure: Pain Catastrophizing Score
timeFrame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
measure: BRIEF Health Literacy Score
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12)
measure: Executive Function
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
measure: Anxiety Levels
timeFrame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
measure: Depression Levels
timeFrame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
measure: Sleep Impact Short Form Score
timeFrame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
measure: Functional Activities of Daily Living
timeFrame: Baseline, week 4, week 8 and 4 weeks post-intervention (week 12)
measure: Chronic Pain Disability Score
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
measure: Average Healthcare Utilization
timeFrame: Baseline
measure: Number of Analgesics
timeFrame: Time period 1 (days 1-28) and time period 2 (days 29-56)
measure: Quality of Life: Frequency of Sickle Cell Pain Episodes
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
measure: Quality of Life: Severity of Sickle Cell Pain Episodes
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
measure: Quality of Life: Emotional Impact
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
measure: Quality of Life: Social Functioning
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
measure: Quality of Life: Stiffness Impact
timeFrame: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital - Outpatient Sickle Cell Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Nadine Matthie, PhD, RN, CNL
role: PRINCIPAL_INVESTIGATOR
References: