Data category | Information |
---|---|
1. Primary registry and trial identification number | ISRCTN16412551 |
2. Date of registration in primary registry | 30 July 2014 |
3. Secondary identifying numbers | GKV-SV201 |
4. Source(s) of monetary or material support | Long-Term Care Insurance Funds (GKV-Spitzenverband), German National Association of the Statutory Health Insurance and |
5. Primary sponsor | Long-Term Care Insurance Funds (GKV-Spitzenverband), German National Association of the Statutory Health Insurance and |
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 PD Dr. Katharina Luttenberger, katharina.luttenberger@uk-erlangen.de |
9. Public title | The German Day-Care Study |
10. Scientific title | Multimodal non-drug therapy for persons with cognitive decline in day-care institutions with short-term interventions for informal caregivers by telephone to strengthen the compatibility of care and work |
11. Countries of recruitment | Germany |
12. Health condition(s) or problem(s) studied | Mild cognitive impairment, mild or moderate dementia (degenerative type, not solely vascular) |
13. Intervention(s) | Intervention group: Activation therapy for day-care users with cognitive impairment |
Control group: usual care offered in each day care (treatment as usual) | |
Informal caregiver: telephone intervention | |
14. Key inclusion and exclusion criteria | Ages eligible for study: adults; Sexes eligible for study: both |
Inclusion criteria: | |
1. Users of day-care centres with mild cognitive impairment or early dementia who have an informal caregiver | |
2. Informed consent | |
Exclusion criteria: | |
1. Completely blind or deaf | |
2. No informal caregiver at all | |
3. Severe dementia | |
4. Cognitive decline due to diseases other than dementia (e.g. schizophrenia or Korsakov) | |
15. Study type | Cluster-randomised controlled intervention study |
16. Date of first enrolment | October 2014 |
17. Target sample size | 350 |
18. Recruitment status | Complete |
19. Primary outcome(s) | Users of day-care centres: cognition (MMSE), activities of daily living (ETAM) |
Caregivers: subjective burden (HPS-K), well-being (WHO-5) | |
20. Key secondary outcomes | Users of day-care centres: e.g. NPI-Q, EQ-5D |
Caregivers: EQ-5D, BIZA-D |