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Active, Not Recruiting

NCT Number: NCT05413733

Neuropsychological Rehabilitation Over the Internet

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Stroke, Acute Ischemic Brain Diseases Brain Hemorrhage Brain Injuries Brain Injuries, Traumatic Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Encephalitis Hemorrhage Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Stroke Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HUS Neurocenter, Helsinki University Hospital

Helsinki, FI-00029, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital care pathway

Behavioral

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

Care as usual

Behavioral

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.

Primary outcomes

  1. Change of Baseline Perceived Subjective Cognitive symptoms at 2 months and 5 months

    Time frame: 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

Secondary outcomes

  1. Change of Baseline Perceived Use of Memory Aids at 2 months and 5 months

    Time frame: Baseline, Month 2, and Month 5

    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.

  2. Change of Baseline Perceived Self-Efficacy at 2 months and 5 months

    Time frame: Baseline, Month 2, and Month 5

    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

  3. Change of Baseline Perceived Anxiety at 2 months and 5 months

    Time frame: Baseline, Month 2, and Month 5

    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

  4. Change of Baseline Perceived Depression at 2 months and 5 months

    Time frame: Baseline, Month 2, and Month 5

    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

  5. Change of Baseline Perceived Quality of life at 2 months and 5 months

    Time frame: Baseline, Month 2, and Month 5

    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

  6. Change of Baseline Perceived Fatigue at 2 months and 5 months

    Time frame: Baseline, Month 2, and Month 5

    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

Other outcomes

  1. Change of Baseline Perceived Working ability at 2 months and 5 months

    Time frame: Baseline, Month 2, and Month 5

    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

  2. Length of sick leave of a patient

    Time frame: Month 5

    Length of sick leave in days after acquired brain injury

  3. Intervention feedback questionnaire

    Time frame: Month 2

    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

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Acronym: IRENE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2022
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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