Neuropsychological Rehabilitation Over the Internet

NCT05413733 | Active Not Recruiting

• 1 other identifier: TYH2022304
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke, Acute Ischemic; Brain Hemorrhage; Encephalitis; Hypoxia-Ischemia, Brain; Traumatic Brain Injury

Keywords

web-based intervention; neuropsychological rehabilitation; psychoeducation; acquired brain injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  Baseline, Month 2, and Month 5

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

  Baseline, Month 2, and Month 5

• Change of Baseline Perceived Anxiety at 2 months and 5 months

  Baseline, Month 2, and Month 5

• Change of Baseline Perceived Depression at 2 months and 5 months

  Baseline, Month 2, and Month 5

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

  Baseline, Month 2, and Month 5

Other Outcomes (3)

• Change of Baseline Perceived Working ability at 2 months and 5 months

  Baseline, Month 2, and Month 5

• Length of sick leave of a patient

  Month 5

• Intervention feedback questionnaire

  Month 2

Study Arms (2)

Digital care pathway

EXPERIMENTAL

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

Care as usual

ACTIVE COMPARATOR

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

Interventions

Digital care pathway BEHAVIORAL

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

Also known as: iRENE Digital pathway

Digital care 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.

Care as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

HUS Neurocenter, Helsinki University Hospital

Helsinki, FI-00029, Finland

Location

Related Links

• Short introduction to My Path in Health Village

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Hemorrhages; Encephalitis; Hypoxia-Ischemia, Brain; Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Brain Ischemia; Hypoxia, Brain; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Marja Hietanen, PhD

  Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Digital care pathway is part of the daily neurological treatment at HUS. Care providers will be clinical neuropsychologists who do not know if their patient is involved in the study or not.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neuropsychologist

Model Details: A parallel-group randomized controlled trial

Study Record Dates

• First Submitted: May 28, 2022
• First Posted: June 10, 2022
• Study Start: August 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)