Table 1 Trial registration data
Data category | Information |
|---|---|
1. Primary registry and trial identification number | ISRCTN14437015 |
2. Date of registration in primary registry | 27.02.2020 |
3. Secondary identifying numbers | - |
4. Source(s) of monetary or material support | Reinhard Frank-Stiftung |
5. Primary sponsor | Reinhard Frank-Stiftung |
6. Secondary sponsor(s) | - |
7. Contact for public queries | see point 8 |
8. Contact for scientific queries | Prof. Dr. Elmar Graessel, elmar.graessel@uk-erlangen.de |
9. Public title | Dementia prevention for older people suffering from mild cognitive impairment using computerised cognitive training tools |
10. Scientific title | Individualised computerised cognitive training for community-dwelling people with mild cognitive impairment |
11. Countries of recruitment | Germany |
12. Health condition(s) or problem(s) studied | Mild cognitive impairment (MCI) |
13. Intervention(s) | Intervention group: Individualised computerised cognitive training, which involves targeted exercises for memory span, information processing, visual-spatial cognition, etc. |
Control group: basic computerised cognitive training, which involves basic exercises for memory span, information processing, visual-spatial cognition, etc. | |
14. Key inclusion and exclusion criteria | Inclusion criteria: 1. MCI 1.1. Montreal Cognitive Assessment score (MoCA) ≤ 24 1.2. Mini Mental State Examination score (MMSE) ≥ 24 2. Own computer/laptop/tablet and basic skills in their use3. Age ≥ 60 4. Informed consent given |
Exclusion criteria: 1. Completely blind or deaf 2. No personal computer, laptop, or tablet 3. Normal cognition, MoCA ≥ 24 4. Dementia, Mini-Mental Status Examination score < 24 5. Depression, Patient Health Questionnaire 9 score (PHQ-9) ≥ 12 6. Apparent neurological diseases and/or other severe psychiatric diseases | |
15. Study type | Prospective double-blind randomised controlled intervention study |
16. Date of first enrolment | 09.06.2020 |
17. Target sample size | - |
18. Recruitment status | incomplete |
19. Primary outcome(s) | Cognition measured by the Montreal Cognitive Assessment (MoCA) at baseline and after 6 months |
20. Key secondary outcomes | Cognition measured by reaction time and logical thinking assessments delivered and collected by the digital software at baseline and after 1, 2, 3, 4, 5 and 6 months, Mini-Mental Status Examination (MMSE) at baseline and after 6 months Exploratory outcome measures: Long-term cognitive status assessed using the Montreal Cognitive Assessment (MoCA) and the Mini-Mental Status Examination (MMSE), yearly in the open phase |