Study for the evaluation of a mobile application for independent cognitive training - effects on cognitive abilities and quality of life of patients with mild cognitive disorders

Not Applicable

• Conditions: F06.7; U09.9; Mild cognitive disorder; Post COVID-19 condition, unspecified

• Registration Number: DRKS00025133
• Lead Sponsor: Charité- Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-05
• Study Completion: 2023-11-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

Arm 1 & 2 :
- Age = 18 years
- Existing diagnosis of mild cognitive impairment (ICD-10: F06.7)
- Mild cognitive impairment (TICS (Telephone Interview for Cognitive Status) >20 and < 33).
- Ability to consent
- Ability and experience in using a mobile device to use the app
- Able to understand instructions in German language
- Presence of a mobile device to use the app.
Arm 3 & 4 : Post-Covid.
- Age = 18 years
- Current diagnosis of mild cognitive disorder (ICD-10: F06.7) and post-Covid condition (ICD-10 U09.9) Diagnosis
- Capacity to consent
- Ability and experience in using a mobile device to use the app

Exclusion Criteria

Exclusion criteria (all arms):
- Severe cognitive impairment (TICS <21).
- Presence of moderate or severe dementia
- Legal care
- Paresis of the dominant arm or hand
- Visual field defects (e.g., hemianopsia, quadranta-nopsia)
- Severe non-correctable visual impairment (unable to visually recognize app content)
- Severe aphasia that impairs instructional comprehension
- Use of other apps and software (training products) that provide cognitive training

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cognitive abilities, measured with the Neuropsychological Assessment Battery (NAB) at two visits

Secondary Outcome Measures

Name	Time	Method
nderstanding of health and health information (Health Literacy Questionnaire, HLQ), subjective cognitive ability (Cognitive Failure questionnaire, CFQ), psychosocial health (Health-49, Dimension B - Psychological Well-Being and Dimension D - Self-Efficacy), depressive symptoms (Hospital Anxiety and Depression Scale, HADS), Usability (System Usability Scale, SUS), patient diary of the additional cognitive activating training performed and the respective training duration