Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT05413733
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.
Study:
NCT05413733
Study Brief:
Protocol Section:
NCT05413733