Home-Based Intervention for Chronic Pain in Adults With Sickle Cell Disease (HIPAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Pain Rating Using Numerical Pain Rating Scale (NPRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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
研究组 & 干预措施
Active control Group
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.
干预措施: Audio-only version of EaseVRx (Behavioral)
EaseVRx Group
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.
干预措施: EaseVRx (Device)
结局指标
主要结局
Pain Rating Using Numerical Pain Rating Scale (NPRS)
时间窗: Baseline, up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)
For daily measures, 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. Daily Pain Diary responses were intermittent and can only be aggregated during time period 1 (days 1-28) and time period 2 (days 29-56). Diaries were not administered at day 0.
Pain Intensity Subscale of the Chronic Pain Grade Questionnaire
时间窗: Baseline, week 4, week 8, and 4 weeks post-intervention (week 12)
For baseline and monthly measurements, self-reported pain ratings were assessed with the Pain Intensity subscale of the Chronic Pain Grade Questionnaire. On the Chronic Pain Grade Questionnaire, pain intensity levels range from 0-100. Lower pain ratings correlate with better outcome.
Participant Engagement: Minutes of Program Use Per Day
时间窗: up to week 4 or time period 1 (day 1-28), from week 4 to 8 or time period 2 (days 29-56)
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. Because of intermittent usage patterns, self-reported program use was aggregated during time period 1 (days 1-28) and time period 2 (days 29-56).
Participant Engagement: Duration in Days
时间窗: 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)
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.
Participant Engagement: Features Utilized
时间窗: Daily during treatment (8 weeks)
Assessed by the number of features utilized when using the VRdevice. The number of features utilized may be 1 or 2 . The investigator hypothesizes that use of a higher number of features will correlate with a better outcome.
Participant Engagement: Completion Rates
时间窗: Daily average during treatment (up to 8 weeks)
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.
Study Retention: Surveys
时间窗: Baseline, 4 weeks, 8 weeks and 4 weeks post-intervention (week 12)
Assessed by participant completion of survey measures at repeated timepoints (baseline, week 4, week 8, and week 12). The investigator hypothesizes that higher study retention will correlate with a better outcome.
Study Retention: Daily Diaries
时间窗: Up to 8 weeks
Assessed by participant completion of daily diaries across 8 weeks of treatment (days 1-56). The investigator hypothesizes that higher study retention will correlate with a better outcome.
Participant Satisfaction
时间窗: Post-treatment (up to 6 weeks post-treatment)
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 with possible score range 1-4) 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.
Frequency of Highest Satisfaction Scores
时间窗: Post-treatment (up to 6 weeks post-treatment)
Assessed once at the end of the program, via individual qualitative interviews or focus group sessions. Participants choosing the highest score for each of the four items listed will be counted. Higher number correlates with a better outcome.
Safety: Number of Adverse Events
时间窗: 4 weeks, 8 weeks, up to 6 weeks post-treatment
Assessed by monitoring participants for the number of adverse events. Fewer adverse events correlate with a better outcome.
次要结局
- Chronic Pain Acceptance Score(Baseline, week 4, week 8 and 4 weeks post-intervention (week 12))
- Chronic Pain Self-Efficacy(Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12))
- Social Support(Baseline, week 4, week 8, and 4 weeks post-intervention (12 weeks))
- Pain Catastrophizing Score(Baseline, week 4, week 8 and 4 weeks post-intervention (week 12))
- BRIEF Health Literacy Score(Baseline, week 4, week 8, and 4 weeks post-intervention (Week 12))
- Executive Function(Baseline, week 4, week 8, and 4 weeks post-intervention (week 12))
- Anxiety Levels(Baseline, week 4, week 8 and 4 weeks post-intervention (week 12))
- Depression Levels(Baseline, week 4, week 8 and 4 weeks post-intervention (week 12))
- Sleep Impact Short Form Score(Baseline, week 4, week 8 and 4 weeks post-intervention (week 12))
- Functional Activities of Daily Living(Baseline, week 4, week 8 and 4 weeks post-intervention (week 12))
- Chronic Pain Disability Score(Baseline, week 4, week 8, and 4 weeks post-intervention (week 12))
- Average Healthcare Utilization(Baseline)
- Number of Analgesics(Time period 1 (days 1-28) and time period 2 (days 29-56))
- Quality of Life: Frequency of Sickle Cell Pain Episodes(Baseline, week 4, week 8, and 4 weeks post-intervention (week 12))
- Quality of Life: Severity of Sickle Cell Pain Episodes(Baseline, week 4, week 8, and 4 weeks post-intervention (week 12))
- Quality of Life: Emotional Impact(Baseline, week 4, week 8, and 4 weeks post-intervention (week 12))
- Quality of Life: Social Functioning(Baseline, week 4, week 8, and 4 weeks post-intervention (week 12))
- Quality of Life: Stiffness Impact(Baseline, week 4, week 8, and 4 weeks post-intervention (week 12))
研究者
Nadine Matthie
Assistant Professor
Emory University