Living Well with Chronic Pain: Using Person-centered E-health Design to Support Self-management
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Brief Pain Inventory (BPI) (Short Form) - Assessing change
研究概览
简要总结
The goal of this project is to test the effect of an interactive e-health intervention for people with chronic pain.
详细描述
Chronic pain conditions are common and difficult to cure. As much as 30% of adults in Norway experience moderate-to-severe chronic pain, i.e., pain having lasted more than 3 months. Chronic pain is also the most common cause of sick leave and disability pension in Norway. Despite a clear request from the authorities, e-health interventions for chronic pain has not yet been tested and implemented.
The aim of this study is to investigate the effect of an interactive e-health intervention for people living with chronic pain, using outcome measures such as pain intensity, pain acceptance, anxiety/depression and quality of life.
The e-health intervention will first be tested in a pilot study with 50 patients with different pain diagnoses and eventually in a randomized controlled trial with a sample of 240 patients with different pain diagnoses. The intervention will consist of one face-to-face introductory group followed by 9 app-based modules containing cognitive behavioral pain self-management material. The 9 modules will be distributed over minimum 27 days (minimum 3 days per module). The participants in the randomized controlled trial will be randomly assigned to use the e-health intervention or to a treatment as usual control group. Both groups will receive outcome measures to complete at baseline and at 3, 6 and 12 months.
Post-RCT, the EPIO study will also include a non-randomized group receiving the app-based EPIO program but without receiving an introduction session and follow up phone calls to examine potential benefits from receiving the app-based program only.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain (pain > 3 months)
- •> 18 years of age
- •Able to write/read/speak Norwegian
- •Have their own smart phone, PC or tablet
排除标准
- •Cancer related pain
研究组 & 干预措施
EPIO (e-health intervention)
Participants will get access to one module every third day (total 9 modules). The app consists of cognitive behavioral pain self-management material, including educational material and relaxation training exercises.
干预措施: EPIO (Behavioral)
treatment as usual
Participants will get treatment as usual during the study. All participants will get access to the app after ended study if interested.
Experimental without introduction group and follow up phone calls
One extra arm (non randomized) has been included to examine whether participants who receive the EPIO intervention without receiving an introduction session and follow up phone calls will still describe benefiting from the receiving the intervention
干预措施: EPIO (Behavioral)
结局指标
主要结局
Brief Pain Inventory (BPI) (Short Form) - Assessing change
时间窗: Baseline, and at 3, 6, and 12 months.
9 item scale measuring pain interference on function. Using this measure, respondents rate their worst, least, average, and current pain intensity and also rate the degree to which pain interferes with 7 domains of functioning (general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life) on a scale of 0 to 10. There is no scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.
次要结局
- Chronic Pain Acceptance Questionnaire (CPAQ) - Assessing change(Baseline, and at 3, 6, and 12 months.)
- Self-Regulatory Fatigue 18 (SRF-18) - Assessing change(Baseline, and at 3, 6, and 12 months.)
- The Hospital Anxiety and Depression Scale (HADS) - Assessing change(Baseline, and at 3, 6, and 12 months.)
- Pain Catastrophizing Scale (PCS) - Assessing change(Baseline, and at 3, 6, and 12 months.)
- System Usability Scale (SUS)(At 3 months)
- RAND Health Related Quality of Life - Assessing change(Baseline, and at 3, 6, and 12 months.)
研究者
Lise Solberg Nes
Center Director, Head of Research
Oslo University Hospital