Get Going After concussIonN Lite (GAIN Lite): A Digital Intervention to Reduce Impairing Post-concussional Mild-to-moderate Symptoms in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Rivermead Post-concussion Questionnaire (RPQ/DK)
研究概览
简要总结
Background:
Concussion affects around 25 000 people each year in Denmark. A large research initiative (GAIN 2.0) has been established, and the current study is a part of this initiative.
Aims:
- To develop and test the efficacy of a novel intervention for people with persistent post-concussional mild-to-moderate symptoms: "Get going After concussion Lite" (GAIN Lite).
- To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load.
Methods:
A randomized controlled trial, comparing GAIN Lite to enhanced usual care. 100 adults diagnosed with a concussion at hospitals in Central Denmark Region or referred from general practitioners will be recruited. GAIN Lite is a digital intervention, and the primary outcome is the severity of post-concussional symptoms. A prospective cohort study will be performed to investigate the association between physical activity, cognitive processing, and symptom load.
详细描述
Get going After concussIonN Lite (GAIN Lite): An digital intervention to reduce impairing post-concussional mild-to-moderate symptoms in adults
Background:
Concussion, the mildest form of traumatic brain injury, is an important public health concern, affecting around 25 000 people each year in Denmark. Symptoms are associated with high societal burden due to the long-term impact on labour market attachment and increased health care usage and social welfare benefits. Evidence for effective treatment strategies is scarce, resulting in only weak recommendations for most treatment approaches, as reflected in the recently published National Guidelines for Non-Pharmacological treatment for post-concussion symptoms (PCS). Recently, the effect of a novel intervention "Get going After concussIoN" (GAIN) for people with persistent severe PCS was examined with promising results. Based on GAIN, a large research initiative (GAIN 2.0), has been established, and the present study is a part of this initiative.
Aims
- To develop and test the efficacy of a digital intervention for people with persistent mild-to-moderate PCS: "Get going After concussion Lite" (GAIN Lite).
- To increase the knowledge about the target group by investigating the association of physical activity, digital behaviour, and symptom load.
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 (Care Provider)
盲法说明
Both groups will recieve enhanced usual care. The care providers providing the enhanced usual care, will be blinded to group assignment. As the outcome assessor are the participants when the outcome is participant-reported outcomes, none of the outcome assessors are blinded, as it is impossible to blind the participants to group assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri (26). The criteria are based on recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas;
- •Age 18 to 60 years at the time of the trauma;
- •A total score of 10-30 on RPQ within 1 week before enrolment in the study;
- •Able to understand, speak and read Danish;
- •Living in Central Denmark Region;
- •Identified from registers of the emergency departments or referred by GPs to GAIN Lite within 2-4 months after a concussion
排除标准
- •Objective neurological findings and/or acute trauma CT scan indicating neurological disease or brain damage linked to the concussion, if performed;
- •Previous concussion within the last 2 years with ongoing PCS at the time of the present concussion
- •Severe misuse of alcohol, prescription drugs and/or illegal drugs
- •Severe psychiatric co-morbidity (e.g. bipolar disorder, autism, psychotic disorder (life time)) or severe neurological disease (e.g. multiple sclerosis) that impedes participation in the programme.
结局指标
主要结局
Rivermead Post-concussion Questionnaire (RPQ/DK)
时间窗: 6 months: From baseline to 24 weeks after baseline
RPQ/DK is a self-report questionaire to measure the severity of post-concussion symptoms covering physical, cognitive, and emotional symptoms with 16 sub-items and a total sum score (range 0-64, higher score define more severe status)
Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P/DK)
时间窗: 6 months: From baseline to 24 weeks after baseline
USER-P/DK is a self-report questionaire that covers aspects of participation with three separate scales: Frequency, Restrictions and Satisfaction. The restrictions scale will be used. It contains 11 sub-items that are based on whether the participant experience any limitations in daily life. A sum score from 0-100 i created. (A higher score indicates a more favorable level of participation, i.e. fewer restrictions experienced.)
次要结局
- Brief Illness Perception Questionnaire (B-IPQ/DK)(3 months: From baseline to 12 weeks after baseline (End of treatment))
- Behavioral Response to Illness Questionnaire (BRIQ/DK)(3 months: From baseline to 12 weeks after baseline (End of treatment))
- Treatment Inventory of Costs in Patients with psychiatric disorders (TiC-P)(9 months: From baseline to 36 weeks after baseline)
- Work Ability Index Short form (WAI-2)(9 months: From baseline to 36 weeks after baseline)