Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
150 participants
INTERVENTIONAL
2022-08-01
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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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.
Digital care pathway
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
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.
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.
Interventions
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Digital care pathway
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Eeva-Liisa Kallio
Neuropsychologist
Principal Investigators
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Marja Hietanen, PhD
Role: STUDY_DIRECTOR
Helsinki University Central Hospital
Locations
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HUS Neurocenter, Helsinki University Hospital
Helsinki, , Finland
Countries
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Related Links
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Short introduction to My Path in Health Village
Other Identifiers
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TYH2022304
Identifier Type: -
Identifier Source: org_study_id
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