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Riabilitazione neuropsicologica via Internet (IRENE)

15 settembre 2026 aggiornato da: Eeva-Liisa Kallio, Helsinki University Central Hospital

Fattibilità ed efficacia della riabilitazione neuropsicologica basata sul Web dopo lesioni cerebrali acquisite

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

21

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.

Sessions of the digital neuropsychological program:

  1. Subjective functional ability and goals
  2. Fatigue after ABI
  3. Attention and concentration
  4. Memory
  5. Memory strategies
  6. Working memory and executive functions
  7. Emotional reactions
  8. Summary and future goals
Altri nomi:
  • iRENE Percorso digitale
Comparatore attivo: 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.

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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of Baseline Perceived Subjective Cognitive symptoms at 2 months and 5 months
Lasso di tempo: 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

Baseline, Month 2, and Month 5

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of Baseline Perceived Use of Memory Aids at 2 months and 5 months
Lasso di tempo: 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.

Baseline, Month 2, and Month 5
Change of Baseline Perceived Self-Efficacy at 2 months and 5 months
Lasso di tempo: 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

Baseline, Month 2, and Month 5
Change of Baseline Perceived Anxiety at 2 months and 5 months
Lasso di tempo: 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

Baseline, Month 2, and Month 5
Change of Baseline Perceived Depression at 2 months and 5 months
Lasso di tempo: 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

Baseline, Month 2, and Month 5
Change of Baseline Perceived Quality of life at 2 months and 5 months
Lasso di tempo: 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

Baseline, Month 2, and Month 5
Change of Baseline Perceived Fatigue at 2 months and 5 months
Lasso di tempo: 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

Baseline, Month 2, and Month 5

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Change of Baseline Perceived Working ability at 2 months and 5 months
Lasso di tempo: 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

Baseline, Month 2, and Month 5
Length of sick leave of a patient
Lasso di tempo: Month 5

Length of sick leave in days after acquired brain injury

Month 5
Intervention feedback questionnaire
Lasso di tempo: 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

Month 2

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Marja Hietanen, PhD, Helsinki University Central Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 agosto 2022

Completamento primario (Effettivo)

9 maggio 2025

Completamento dello studio (Effettivo)

31 luglio 2025

Date di iscrizione allo studio

Primo inviato

28 maggio 2022

Primo inviato che soddisfa i criteri di controllo qualità

7 giugno 2022

Primo Inserito (Effettivo)

10 giugno 2022

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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