Interdisciplinary Rehabilitation for Patients With Chronic Pain in Primary Healthcare
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Health related quality of life
研究概览
简要总结
Purpose: The overall aim is to investigate the effect of interdisciplinary rehabilitation in primary health care (PHC) for patients with chronic pain. Specific questions: What is the effect of extended access to the interdisciplinary PHC pain team + a booster session after finishing the rehabilitation program? Does participation in PHC interdisciplinary rehabilitation contribute to health improvements and are there predictors of this? Method: A randomized controlled trial (RCT). 200 patients with chronic pain that participate in interdisciplinary rehabilitation in primary healthcare in Region Västra Götaland (VGR) in Sweden will be included in the RCT and randomized to Intervention; standard care by the interdisciplinary teams in PHC + extended access to the team and a booster session 3 months after the end of the rehabilitation, or Control; only standard care by the interdisciplinary teams. Outcomes are health related quality of life, pain intensity and other health aspects.
详细描述
The participants will be randomly allocated to intervention or active control. All participants in both arms receive the standard care for interdisciplinary rehabilitation at any of the six PHC pain teams in VGR. The teams consist of a physician, physiotherapist, occupational therapist and psychologist. All teams provide person-centred rehabilitation, aiming to increase physical activity and support behavioural changes, and to decrease symptoms and the impact of pain on the patients´ daily lives. The standard care interdisciplinary rehabilitation period contains both theoretical and practical components such as patient education, physical exercise and behavioural interventions. The sessions are mainly group-based. The duration of the rehabilitation period varies between 5 to 7 weeks + a follow-up visit after 3 months.
The participants in the intervention arm also receive an extra booster-session 3 months after the standard follow-up. At the booster-session, the participant´s individual rehabilitation plan is followed-up and adjusted. This extra period also includes extended access to the team, meaning that the participants have the possibility to contact the team and, if needed, have digital or telephone contact.
The participants complete a battery of questionaires included in the Swedish Quality Registry for Pain Rehabilitation an also extra questionnaires provided to the participants through an electronic research form.
Data collection is made at baseline before starting the rehabilitation, directly after the 5 to 7 weeks rehabilitation period and 6, 12 and 24 months after baseline.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons participating in interdisciplinary team rehabilitation in primary healthcare in Region Västra Götaland, Sweden.
排除标准
- •Severe psychiatric disease, language difficulties that makes it impossible to complete the questionnaires
研究组 & 干预措施
Interdisciplinary rehabilitation + booster-session (intervention)
Standard care by the interdisciplinary rehabilitation teams in primary healthcare + extended access to the team and a booster visit after 3 months.
干预措施: Interdisciplinary care + booster session (intervention) (Other)
Interdisciplinary rehabilitation (control)
Standard care by the interdisciplinary rehabilitation teams in primary healthcare.
干预措施: Interdisciplinary care (control) (Other)
结局指标
主要结局
Health related quality of life
时间窗: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Rand-36 (0-100, a higher score indicates better health-related quality of life)
Pain intensity
时间窗: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
Assessed with visual analog scale and numeric rating scale (0-100 mm, higher is more severe pain)
Health related quality of life 2
时间窗: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
EuroQol 5D-3L (0-100, a higher score indicates better health-related quality of life)
Health related quality of life 3
时间窗: Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.
EuroQol-Visual analogue scale (0-100, a higher score indicates better health-related quality of life)
次要结局
- Self-efficacy(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from from the end of the rehabilitation period.)
- Pain spread(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
- Pain catastrophizing(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
- Health care use(From 12 months before to 24 months after the rehabilitation period.)
- Pain acceptance(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
- Symptoms of stress(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
- Physical activity(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
- Self-rated function(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
- Work ability(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
- Sickness abscence(From 12 months before to 24 months after the rehabilitation period.)
- Anxiety and depression(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
- Life satisfaction(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
- Patients´ own impression of change(Directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)
- Fatigue(Baseline, directly after the rehabilitation period and 6, 12 and 24 months from the end of the rehabilitation period.)