Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With ABI

NCT06749197 | Recruiting

• 2 other identifiers: 1325410960102410036
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury (Including Stroke)

Keywords

cognition; cognitive impairment; attention deficit; memory disorder; computerized cognitive training; home-based training

Outcome Measures

Primary Outcomes (5)

• General cognition

  The Montreal Cognitive Assessment (MoCA) will be used for general cognitive screening for all patients at baseline measurement and after 6 and 12 weeks.

  12 weeks

• Selective attention

  The D2 test is used to measure change in visual selective attention, processing speed and concentration at the baseline visit, after 6 and 12 weeks.

  12 weeks

• Executive attention

  The Stroop Test is used as a measure of mental speed, executive attention and response inhibition in all participants of the study at the baseline measurement, and after 6 and 12 weeks follow-up.

  12 weeks

• Divided attention

  The Trail Making Test (TMT A\&B) is used to measure change in executive function (divided attention) and processing speed at the baseline measurement, after 6 weeks and 12 weeks follow up.

  12 weeks

• Working memory

  Working memory is measured in all patients at baseline measurement, after 6 weeks and at 12 weeks follow-up with the use of the Digit Span Forward (DSF) and Digit Span Backward (DSB) test (part of the Wechsler adult intelligence scale). It involves the oral presentation of spans of digits. The measure has both a 7-item digits forward task and a 7-item digits backward task, each one with its own individual score. Together with 'calculation' (also a part of the Wechsler adult intelligence scale), an index for working memory can be calculated.

  12 weeks

Secondary Outcomes (6)

• Subjective cognitive complaints

  12 weeks

• Anxiety and depression

  12 weeks

• Health-related quality of life (HR-QoL)

  12 weeks

• Fatigue

  12 weeks

• Coping

  12 weeks

Other Outcomes (1)

• Personality traits neuroticism and extraversion

  Baseline

Study Arms (2)

Early cognitive training, followed by standard care

EXPERIMENTAL

Rehacom, standard care

Device: Rehacom

Standard care, followed by cognitive training

ACTIVE COMPARATOR

Standard care, Rehacom

Device: Rehacom

Interventions

Rehacom DEVICE

Home-based cognitive training program

Early cognitive training, followed by standard care; Standard care, followed by cognitive training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• incapacitated patients like patients diagnosed with dementia

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Rijndam Revalidatiecentrum: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Rijndam Rehabilitation

Rotterdam, South Holland, 3015LJ, Netherlands

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Cognitive Dysfunction; Attention Deficit Disorder with Hyperactivity; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Majanka H Heijenbrok-Kal, PhD

CONTACT

+31 6 28129140; m.heijenbrok@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: March 20, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

NL (1)