Stroke, Acute IschemicIRENENCT05413733
Neuropsychological Rehabilitation Over the Internet
A study testing Digital care pathway and Care as usual in people with Stroke, Acute Ischemic and Brain Hemorrhage, run by Helsinki University Central Hospital at 1 site in Finland.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke, Acute Ischemic, Brain Hemorrhage, Encephalitis
- What is being tested?
- Digital care pathway and Care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFinland
- Study dates
- 1 Aug 2022to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site
HUS Neurocenter, Helsinki University Hospital
Helsinki, FI-00029
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Acute Ischemic, Brain Hemorrhage, Encephalitis, Hypoxia-Ischemia, Brain, Traumatic Brain Injury
- Being tested
- Digital care pathway, Care as usual
- Keywords
- web-based intervention, neuropsychological rehabilitation, psychoeducation, acquired brain injury
- Medical subject headings
- Ischemic Stroke, Intracranial Hemorrhages, Encephalitis, Hypoxia-Ischemia, Brain, Brain Injuries, Traumatic, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital care pathwayBehavioural
Also called iRENE Digital 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 usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Month 2, and Month 5
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, Month 2, and Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Aug 2022
- Primary completion9 May 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, Acute IschemicStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel-group randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eeva-Liisa Kallio, Helsinki University Central Hospital
- Investigators
- Marja Hietanen, PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413733
- Sponsor's protocol ID
- TYH2022304
- Acronym
- IRENE
- Status last verified
- Sep 2026
- First submitted
- 28 May 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Web-based Neuropsychological Rehabilitation After Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT05413733
- Acronym / sponsor ID
- IRENE / TYH2022304
- Conditions
- Stroke, Acute Ischemic, Brain Hemorrhage, Encephalitis, Hypoxia-Ischemia, Brain, Traumatic Brain Injury
- Keywords
- web-based intervention, neuropsychological rehabilitation, psychoeducation, acquired brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 9 May 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A parallel-group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Digital care pathway | Experimental | Behavioral: Digital care pathwayIntervention 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. |
| Care as usual | Active comparator | Behavioral: Care as usualControl 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital care pathwayAlso: iRENE Digital pathwaySessions 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 | Behavioural | Digital care pathway |
| Care as usualThe 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. | Behavioural | Care as usual |
Primary outcome
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
6 secondary outcomes
Change of Baseline Perceived Use of Memory Aids at 2 months and 5 months
Time frame: Baseline, Month 2, and Month 5
Change of Baseline Perceived Self-Efficacy at 2 months and 5 months
Time frame: Baseline, Month 2, and Month 5
Change of Baseline Perceived Anxiety at 2 months and 5 months
Time frame: Baseline, Month 2, and Month 5
Change of Baseline Perceived Depression at 2 months and 5 months
Time frame: Baseline, Month 2, and Month 5
Change of Baseline Perceived Quality of life at 2 months and 5 months
Time frame: Baseline, Month 2, and Month 5
Change of Baseline Perceived Fatigue at 2 months and 5 months
Time frame: Baseline, Month 2, and Month 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marja Hietanen, PhD study director
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital care pathway and Care as usual in people with Stroke, Acute Ischemic and Brain Hemorrhage, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Baseline Perceived Subjective Cognitive symptoms at 2 months and 5 months (time frame: Baseline, Month 2, and Month 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.