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Table 1 Trial registration data

From: The German day-care study: multicomponent non-drug therapy for people with cognitive impairment in day-care centres supplemented with caregiver counselling (DeTaMAKS) – study protocol of a cluster-randomised controlled trial

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