Neuropsychological Rehabilitation Over the Internet (IRENE)

Feasibility and Effectiveness of Web-based Neuropsychological Rehabilitation After Acquired Brain Injury

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Encephalitis; Traumatic Brain Injury; Hypoxia-Ischemia, Brain; Brain Hemorrhage; Stroke, Acute Ischemic
• Intervention / Treatment: Behavioral: Digital care pathway; Behavioral: Care as usual

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, FI-00029
    • HUS Neurocenter, Helsinki University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital care pathway; Intervention group goes through a web-based neuropsychological intervention program. The program includes eight structured sessions regarding general neuropsychological symptoms after ABI - problems with fatigue, attention, executive functions and memory. A new session opens after the previous one is completed, and after a minimum of 3 days between the sessions. The intervention takes approximately 2 months depending on the progression pace of a patient. The eight sessions consist of psychoeducation, self-assessments, cognitive strategy training and feedback (automatic or given by a monitoring neuropsychologist). A neuropsychologist from HUS monitors patients' progression and provides personal feedback when needed. Participants can also be in contact with a monitoring neuropsychologist via message feature of the program.	Behavioral: Digital care pathway; Sessions of the digital neuropsychological program: Subjective functional ability and goals; Fatigue after ABI; Attention and concentration; Memory; Memory strategies; Working memory and executive functions; Emotional reactions; Summary and future goals; Other Names: iRENE Digital pathway
Active Comparator: Care as usual; Control group attends the standard care of patients with ABI in HUS including all necessary outpatient rehabilitation visits. When available, neuropsychological rehabilitation typically takes 1-2 months among the study target group.	Behavioral: Care as usual; The standard care of patients with ABI including all necessary outpatient rehabilitation visits. Neuropsychological visits may include a short period of psychoeducation with a clinical neuropsychologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Baseline Perceived Subjective Cognitive symptoms at 2 months and 5 months	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	Baseline, Month 2, and Month 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Baseline Perceived Use of Memory Aids at 2 months and 5 months	Administration of the Adaptation to Memory Difficulties Outcome Questionnaire; The questionnaire includes subscales assessing memory knowledge and emotional adjustment (15 questions), use of external memory aids (5 questions) and use of internal memory aids (5 questions); Each item will be scored on a 4-point scale 1-4; Each of the three parts of the questionnaire will be analyzed separately; A higher score would signify better adaptation.	Baseline, Month 2, and Month 5
Change of Baseline Perceived Self-Efficacy at 2 months and 5 months	Administration of the New General Self-Efficacy Scale; The New General Self-Efficacy Scale is an 8-item measure that assesses how much people believe they can achieve their goals, despite difficulties; The minimum total score is 1 and the maximum score is 5; The higher total score represents higher self-efficacy	Baseline, Month 2, and Month 5
Change of Baseline Perceived Anxiety at 2 months and 5 months	Administration of the Patient-Reported Outcomes Measurement Information System (PROMIS): anxiety; The minimum total raw score is 8 and the maximum score is 40; The higher total score represents higher anxiety	Baseline, Month 2, and Month 5
Change of Baseline Perceived Depression at 2 months and 5 months	Administration of the Patient-Reported Outcomes Measurement Information System (PROMIS): depression; The minimum total raw score is 8 and the maximum score is 40; The higher total score represents higher depression	Baseline, Month 2, and Month 5
Change of Baseline Perceived Quality of life at 2 months and 5 months	Administration of the Euro-Qol (EQ-5D) Questionnaire; The minimum total raw score is 0 and the maximum score is 100; The higher score represents higher quality of life in terms of self-perceived health	Baseline, Month 2, and Month 5
Change of Baseline Perceived Fatigue at 2 months and 5 months	Administration of the Fatigue Assessment Scale; The minimum total raw score is 10 and the maximum score is 50; The higher total score represents more severe fatigue	Baseline, Month 2, and Month 5

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Baseline Perceived Working ability at 2 months and 5 months	Administration of the Work Ability Index; The minimum total score is 0 and the maximum score is 24; The higher total score represents better self-perceived working ability	Baseline, Month 2, and Month 5
Length of sick leave of a patient	Length of sick leave in days after acquired brain injury	Month 5
Intervention feedback questionnaire	Feedback of the neuropsychological rehabilitation period offered during the study; Participants give their evaluation in a 5-point likert scale; The higher total score represents more positive evaluation; % of patients with positive and negative evaluation will be reported	Month 2

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Investigators: Study Director: Marja Hietanen, PhD, Helsinki University Central Hospital

Publications and helpful links

Helpful Links

• Short introduction to My Path in Health Village

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 28, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: acquired brain injury; psychoeducation; web-based intervention; neuropsychological rehabilitation
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Signs and Symptoms, Respiratory; Craniocerebral Trauma; Trauma, Nervous System; Hypoxia, Brain; Ischemic Stroke; Stroke; Hypoxia; Brain Injuries; Encephalitis; Hemorrhage; Brain Ischemia; Hypoxia-Ischemia, Brain; Intracranial Hemorrhages
• Other Study ID Numbers: TYH2022304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No