Clinical trial NCT06749197: Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients with ABI
Official title: Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients with Acquired Brain Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acquired Brain Injury (including Stroke)
Keywords: cognition
cognitive impairment
attention deficit
memory disorder
computerized cognitive training
home-based training
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Rijndam Revalidatiecentrum
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Rationale: Patients with acquired brain injury (ABI) may suffer from persistent cognitive deficits and/or subjective cognitive complaints, especially in the domains of attention and working memory. Cognitive deficits are associated with anxiety and depression and may affect social participation and health-related quality of life (HR-QoL). Approximately 25% of the patients with ABI will be referred to an in- and/or outpatient rehabilitation center for multidisciplinary therapy to optimize recovery. Multiple studies suggest that supervised computerized cognitive training (CCT) may enhance cognitive functioning in patients with ABI. Recently, the CCT program RehaCom was introduced as an online version which is suitable for home training. In this study the feasibility and outcomes of implementing home-based CCT into a blended care pathway will be investigated in patients receiving outpatient rehabilitation therapy after ABI.

Objective: The aim of this study is to assess the feasibility and to evaluate the effect of blending a home-based CCT program (RehaCom) in standard care on cognitive functioning in patients after ABI.

The secondary aim is to evaluate the effect of this CCT program on subjective cognitive complaints, self-efficacy, psychological outcome measures and HR-QoL.

Study design: Randomized cross-over trial comparing a 5-week blended care pathway to 5 weeks of standard care within 30 patients with ABI.

Study population: Adults with ABI receiving outpatient rehabilitation therapy.

Intervention: A blended care pathway including 1 cognitive strategy training session of 1 hour per week in the outpatient rehabilitation center in combination with home-based CCT in 4 sessions of 30 minutes per week, during 5 weeks. The standard care pathway includes 2 cognitive training sessions of 1 hour per week in the outpatient rehabilitation center during 5 weeks.

Main study parameters/endpoints: Cognitive functioning (attention and working memory), self-efficacy, psychological functioning (coping, anxiety, depression) and HR-QoL, using non-invasive neuropsychological tests and standardized online questionnaires. All outcomes will be assessed at baseline (T0), after 6 weeks (T1) and after 12 weeks (T2).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In the blended care pathway patients will be instructed to follow a home-based CCT program. Training at home requires a time investment from patients but will also reduce the number of visits to the rehabilitation center. Participants can choose what time of the day is most convenient for them to engage in the program in their home environment instead of traveling to the rehabilitation center for scheduled cognitive training. Increasing patients' responsibility in their recovery process may improve their self-efficacy and HRQoL.

Completion of online questionnaires also requires a certain time investment from patients and might lead to temporary fatigue. Patients may take a break at any moment and continue completing the questionnaires at a later time. By a maximum duration of 45 to 60 minutes per measurement we aim to minimize the burden for patients. There are no risks associated with participation.


Eligibility criteria: Inclusion Criteria:

* diagnosed with acquired brain injury
* receiving outpatient rehabilitation
* sufficient command of Dutch or English language
* internet access

Exclusion Criteria:

* incapacitated patients like patients diagnosed with dementia

Primary outcomes:
measure: General cognition
timeFrame: 12 weeks
measure: Selective attention
timeFrame: 12 weeks
measure: Executive attention
timeFrame: 12 weeks
measure: Divided attention
timeFrame: 12 weeks
measure: Working memory
timeFrame: 12 weeks
Secondary outcomes:
measure: Subjective cognitive complaints
timeFrame: 12 weeks
measure: Anxiety and depression
timeFrame: 12 weeks
measure: Health-related quality of life (HR-QoL)
timeFrame: 12 weeks
measure: Fatigue
timeFrame: 12 weeks
measure: Coping
timeFrame: 12 weeks
measure: General Self-Efficacy
timeFrame: 12 weeks
Other outcomes:
measure: Personality traits neuroticism and extraversion
timeFrame: Baseline
Locations:
Study officials:
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