Evidence-based Pain Intervention for Veterans: Leveraging Mobile & Social Media: A Randomized 262-subject Controlled Trial of AtEase, a Pain Self-management App in the Treatment of Chronic Pain in Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 4
- 主要终点
- PEG
研究概览
简要总结
This study is a randomized controlled trial to test the efficacy AtEase, a pain self-management app in a sample of Veterans with chronic musculoskeletal pain. The primary outcome is changes in PEG scores from baseline to final follow-up (12 months).
详细描述
The primary objectives of this project are to develop and examine the effectiveness of a mobile app (AtEase) that is designed to provide tailored behavior change guidance to promote pain self-management, healthy sleep habits, and effective stress management in a randomized clinical trial including 262 Veterans with chronic pain.
Veterans will be recruited from VA Connecticut Healthcare, as well as from numerous diverse community recruitment channels (including employers, community groups that provide services for Veterans, Student Veterans of America, and social media).
Eligible Veterans will be randomized to receive access to AtEase or the comparison intervention (a mobile-optimized adaptation of Chronic Pain Education for Veterans) for a total of 6 months. AtEase is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies. Chronic Pain Education for Veterans is a free VA-endorsed publicly available pain management online educational curriculum that provides cognitive-behavioral therapy-based pain self-management materials.
Between the baseline assessment and the 6-month follow up assessment, participants will have unlimited access AtEase or the Chronic Pain Education for Veterans program. All participants will complete follow-up assessments at 6 months and 12-months post-baseline.
The primary outcome will be a comparison of PEG scores at 12 months follow-up. Secondary outcomes will include pain,Global Impression of Change; readiness to self-manage pain, manage stress, and engage in healthy sleep habits; well-being; and Post Traumatic Stress Disorder Checklist scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants will be blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female Veteran
- •Chronic musculoskeletal pain defined as (numeric rating scale of >4) (10 point scale) for > 3 months.43
- •Internet connectivity via tablet or mobile phone.
排除标准
- •Life-threatening condition or acute medical conditions that precludes participation
- •Psychiatric conditions that could impair participation
- •Suicidal ideation or intent
- •Inability to read or speak English
- •Unwilling or unable to provide informed consent
结局指标
主要结局
PEG
时间窗: Baseline to 12 months
The PEG is a multi-dimensional three-item assessment that measures average pain rating, as well as both emotional and physical functioning.
次要结局
- Stage of change for healthy sleep habits(Baseline to 12 months)
- Global Impression of Change(12 months)
- Pain Level(Baseline to 12 months)
- Readiness to self-manage pain(Baseline to 12 months)
- Stage of change for stress management(Baseline to 12 months)
- Post-Traumatic Stress Disorder (PTSD) Checklist (PCL-5)(Baseline to 12 months)
- Well-Being(Baseline to 12 months)
研究者
Sara Johnson
Co-President & CEO
Pro-Change Behavior Systems