Neuropsychological Rehabilitation Over the Internet

Traumatic Brain Injury Clinical Trial

— IRENE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05413733
• Other study ID #: TYH2022304
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: Helsinki University Central Hospital
• Contact: Eeva-Liisa Kallio, PhD
• Phone: +358404854547
• Email: eeva-liisa.kallio[@]hus.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Hemorrhage
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Ischemia
• Encephalitis
• Hemorrhage
• Hypoxia
• Hypoxia-Ischemia, Brain
• Intracranial Hemorrhages
• Ischemic Stroke
• Stroke
• Traumatic Brain Injury

Intervention

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
• 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.

Locations

Country	Name	City	State
Finland	HUS Neurocenter, Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Length of sick leave of a patient	Length of sick leave in days after acquired brain injury	Month 5
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Short introduction to My Path in Health Village