Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With ABI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rehacom.
- Who it may be relevant to
- Registry conditions: Acquired Brain Injury (Including Stroke). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With Acquired Brain Injury
Overview
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.
Interventions
- Device Rehacom
Home-based cognitive training program
Primary outcome measures
- General cognition [Time frame: 12 weeks]
- Selective attention [Time frame: 12 weeks]
- Executive attention [Time frame: 12 weeks]
- Divided attention [Time frame: 12 weeks]
- Working memory [Time frame: 12 weeks]
Secondary outcome measures (6)
- Subjective cognitive complaints [Time frame: 12 weeks]
- Anxiety and depression [Time frame: 12 weeks]
- Health-related quality of life (HR-QoL) [Time frame: 12 weeks]
- Fatigue [Time frame: 12 weeks]
- Coping [Time frame: 12 weeks]
- General Self-Efficacy [Time frame: 12 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Rijndam Rehabilitation — Rotterdam
Identifiers
NCT: NCT06749197 · 13254 · 10960102410036