Clinical trial NCT06462703: Tablet-based Application for Cognitive Therapy
Official title: Tablet-based Application for Cognitive Therapy In the Care of Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Injuries
Lead sponsor: Klinikum Floridsdorf
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive impairments such as deficits in attention, executive functions, perception, language, speech, arithmetics, and memory are very common symptoms after acquired brain injury, which can be caused by neurological diseases such as stroke, cerebral haemorrhage or traumatic brain injury. Around 83% of patients with brain injury suffer from a sequelae of cognitive impairments.

Since the effects caused by neurological diseases can vary greatly from person to person, intensive and individual neuro-rehabilitation is necessary to help patients return to an independent life in the best possible way. In the DACH area (i.e., in Germany, Austria, and Switzerland), patients with cognitive impairments following brain injuries generally receive this intensive and interdisciplinary treatment while being hospitalised in an inpatient clinic following acute medical care.

However, once they leave inpatient care facilities, there are insufficient treatment options readily available to them due to limitations/shortages in the healthcare system's resources, although studies indicate that an increase in therapy time (both in outpatient settings at home or in care facilities) enables greater, long-term rehabilitation progress and faster reintegration and participation in everyday life. Thanks to recent technical advancements, digital treatment options now promise the availability of sufficiently frequent and intensive treatment outside of clinic settings. In that context, the myReha therapy software (available as an app on iOS ad Android tablets), a certified medical device, was developed to enable patients to receive individualised and intensive therapy regardless of the healthcare system's constraints. To test the effectiveness of the myReha therapy software, in this two-arm, randomised, controlled study, patients in the intervention group receive treatment through the myReha therapy software in addition to their usual standard care (i.e., care-as-usual - CAU), while the control group only receives CAU. Treatment outcomes (i.e., rehabilitation progress) are measured based on the CERAD-plus.


Eligibility criteria: Inclusion Criteria:

* Cognitive impairment (deficits in attention, arithmetics, executive functions, memory, language, perception) according to CERAD-plus after a diagnosed brain injury ≥ 4 weeks ago
* No prior experience with a therapy app for neurological deficits
* Motivation to use the therapy software regularly
* Sufficiently good German language skills prior to the brain injury

Exclusion Criteria:

* Being unable to use a tablet without assistance
* Severe visual or hearing impairment that interferes with the performance on psychometric testing procedures
* Any pre-existing speech or language disorder or dementia prior to the onset of brain injury
* An ongoing outpatient or inpatient rehabilitation at the time of study inclusion or planned rehabilitation of the primary disease during the study period
* Serious disabling disease(s) which, in the opinion of the investigator, would preclude participation in the study until the follow-up phase
* Pregnancy

Primary outcomes:
measure: Mean change from baseline in CERAD-plus scores
timeFrame: From enrolment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Mean change from baseline in BIAS-R scores
timeFrame: From enrolment to the end of treatment at 12 weeks
measure: Mean change from baseline in CETI score
timeFrame: From enrolment to the end of treatment at 12 weeks
measure: Mean change from baseline in HADS-D scores
timeFrame: From enrolment to the end of treatment at 12 weeks
measure: Mean change from baseline in EQ-5D-5L scores
timeFrame: From enrolment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Klinik Floridsdorf
Study officials:
References: