Implementation of a Home-based Computerized Cognitive Rehabilitation Program for Patients With Acquired Brain Injury

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• diagnosed with acquired brain injury

• receiving outpatient rehabilitation

• sufficient command of Dutch or English language

• internet access

Locations
Other Locations
Netherlands
Rijndam Rehabilitation
RECRUITING
Rotterdam
Contact Information
Primary
Majanka H Heijenbrok-Kal, PhD
m.heijenbrok@erasmusmc.nl
+31 6 28129140
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 30
Treatments
Experimental: Early cognitive training, followed by standard care
Rehacom, standard care
Active_comparator: Standard care, followed by cognitive training
Standard care, Rehacom
Related Therapeutic Areas
Sponsors
Collaborators: Rijndam Revalidatiecentrum, ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov

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