Tablet-based Application for Cognitive Therapy
NCT Number: NCT06462703
Acronym: TACTIC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Brain Injuries
Interventions: DEVICE: Tablet-based neurorehabilitation with myReha
Sponsor: Klinikum Floridsdorf
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-02
Completion Date: 2025-06-01
Locations: Klinik Floridsdorf, Vienna, 1210, Austria

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.

Primary Outcome Measures: Mean change from baseline in CERAD-plus scores, From enrolment to the end of treatment at 12 weeks
Secondary Outcome Measures: Mean change from baseline in BIAS-R scores, From enrolment to the end of treatment at 12 weeks|Mean change from baseline in CETI score, From enrolment to the end of treatment at 12 weeks|Mean change from baseline in HADS-D scores, From enrolment to the end of treatment at 12 weeks|Mean change from baseline in EQ-5D-5L scores, From enrolment to the end of treatment at 12 weeks