Feasibility and Effectiveness of Web-based Neuropsychological Rehabilitation After Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change of Baseline Perceived Subjective Cognitive symptoms at 2 months and 5 months
研究概览
简要总结
Helsinki University Hospital (HUS) has decided on a strategy to provide digital health care services for several medical specialties - a project called the Health Village (HealthVillage.fi). Within Health Village a specific digital My Path program, iRENE Digital Pathway, has been developed for web-based neuropsychological rehabilitation. iRENE Digital Pathway is a structured program for adults with an acquired brain injury (ABI), which utilizes psychoeducative information and self-evaluation questionnaires for attentional, memory and executive disorders with a feedback, and provides training for internal and external memory and other cognitive strategies. The current study will explore if web-based neuropsychological rehabilitation is a feasible and effective method for carrying out rehabilitation for adults with ABI.
详细描述
The IRENE study will explore the application, feasibility and effectiveness of web-based neuropsychological rehabilitation for working-aged patients with ABI during the first year of recovery. This study will adopt a 2-arm randomized controlled design with treatment-as-usual control.
The investigators will determine the feasibility and effectiveness of a web-based rehabilitation program for patients with ABI on their subjective memory difficulties, management of cognitive symptoms, self-efficacy, fatigue, mood, anxiety, quality of life and subjective working ability. The study will examine, if the method is accessible as well as if neurological patients are able and willing to use web-based rehabilitation. The potential health-economic benefits of the new rehabilitation program will be assessed with the duration of patients' sick leave after ABI and through the net benefit of neuropsychological rehabilitation resources.
A pilot randomized trial with 60 participants will be conducted to address the rate of recruitment of the participants, patient acceptability and adherence to study protocol, retention rates and feedback of the iRENE program as well as initial data on effectiveness of this new program. This pilot trial will use an unequal randomization 2:1 to maximize experiences in delivering the digital intervention to patients after ABI. The intervention group will participate in the iRENE Digital Pathway, a web-based rehabilitation program, that takes 2-3 months to complete. The control group attends treatment as usual, which includes necessary outpatient rehabilitation.
Outcome measures at baseline, post-intervention and 3-month follow-up after completing the intervention are gathered as self-assessments.
The participants are adult patients from neurological acute wards and outpatient clinics from HUS, Finland. Patients with ABI typically get referral to neuropsychological examination at the acute or the sub-acute phase of recovery. The examining clinical neuropsychologist offers a patient the possibility to get involved in the research. A neuropsychologist from the research group interviews voluntary patients at hospital or via telephone to confirm patient's interest and fulfillment of inclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Care Provider)
盲法说明
Digital care pathway is part of the daily neurological treatment at HUS. Care providers will be clinical neuropsychologists who do not know if their patient is involved in the study or not.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute neurological incident affecting cognition (stroke, encephalitis, traumatic brain injury, anoxia)
- •Less than 6 months from occurrence of an acute neurological incident
- •Mild to moderate cognitive deficits on a clinical neuropsychological assessment during inpatient or outpatient care after ABI
- •Subjective cognitive symptoms following ABI
- •Proficient in Finnish
- •Must be able to use digital appliances
排除标准
- •Not an acute neurological incident
- •More than 6 months from an acute neurological incident
- •Severe cognitive deficits on a clinical neuropsychological assessment during inpatient or outpatient care after ABI
- •Not fluent in Finnish
- •Not able to use digital appliances
结局指标
主要结局
Change of Baseline Perceived Subjective Cognitive symptoms at 2 months and 5 months
时间窗: Baseline, Month 2, and Month 5
Administration of the Everyday Memory Questionnaire - Revised; The minimum total score is 0 and the maximum score is 52; The higher total score represents more severe subjective cognitive symptoms
次要结局
- Change of Baseline Perceived Self-Efficacy at 2 months and 5 months(Baseline, Month 2, and Month 5)
- Change of Baseline Perceived Anxiety at 2 months and 5 months(Baseline, Month 2, and Month 5)
- Change of Baseline Perceived Use of Memory Aids at 2 months and 5 months(Baseline, Month 2, and Month 5)
- Change of Baseline Perceived Depression at 2 months and 5 months(Baseline, Month 2, and Month 5)
- Change of Baseline Perceived Quality of life at 2 months and 5 months(Baseline, Month 2, and Month 5)
- Change of Baseline Perceived Fatigue at 2 months and 5 months(Baseline, Month 2, and Month 5)
研究者
Eeva-Liisa Kallio
Neuropsychologist
Helsinki University Central Hospital