Clinical trial NCT05413733: Neuropsychological Rehabilitation Over the Internet
Official title: Feasibility and Effectiveness of Web-based Neuropsychological Rehabilitation After Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke, Acute Ischemic
Brain Hemorrhage
Encephalitis
Hypoxia-Ischemia, Brain
Traumatic Brain Injury
Keywords: web-based intervention
neuropsychological rehabilitation
psychoeducation
acquired brain injury
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel-group randomized controlled trial
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Intervention group will go through a systematic web-based neuropsychological intervention program. Participants carry out the web-based intervention independently with their own digital appliance (computer, tablet or mobile phone) time and place of one's choice.

Control group attends the standard care of patients with ABI including all necessary outpatient rehabilitation visits. A possibility to attend to the iRENE Digital Pathway will be offered to control group participants after they have performed the 5-month assessment of the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of Baseline Perceived Subjective Cognitive symptoms at 2 months and 5 months
timeFrame: Baseline, Month 2, and Month 5
Secondary outcomes:
measure: Change of Baseline Perceived Use of Memory Aids at 2 months and 5 months
timeFrame: Baseline, Month 2, and Month 5
measure: Change of Baseline Perceived Self-Efficacy at 2 months and 5 months
timeFrame: Baseline, Month 2, and Month 5
measure: Change of Baseline Perceived Anxiety at 2 months and 5 months
timeFrame: Baseline, Month 2, and Month 5
measure: Change of Baseline Perceived Depression at 2 months and 5 months
timeFrame: Baseline, Month 2, and Month 5
measure: Change of Baseline Perceived Quality of life at 2 months and 5 months
timeFrame: Baseline, Month 2, and Month 5
measure: Change of Baseline Perceived Fatigue at 2 months and 5 months
timeFrame: Baseline, Month 2, and Month 5
Other outcomes:
measure: Change of Baseline Perceived Working ability at 2 months and 5 months
timeFrame: Baseline, Month 2, and Month 5
measure: Length of sick leave of a patient
timeFrame: Month 5
measure: Intervention feedback questionnaire
timeFrame: Month 2
Locations:
city: Helsinki
country: Finland
facility: HUS Neurocenter, Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Marja Hietanen, PhD
role: STUDY_DIRECTOR
References: