Table 2 Trial Registration Data Set of the MAKS-s study

Primary registry and trial identification number

ISRCTN15722923

Date of registration in primary registry

07/08/2019

Secondary identifying numbers

GKV-SV339

Source(s) of monetary or material support

German National Association of the Statutory Health Insurance and Long-Term Care Insurance Funds (GKV-Spitzenverband)

Primary sponsor

German National Association of the Statutory Health Insurance and Long-Term Care Insurance Funds (GKV-Spitzenverband)

Secondary sponsor(s)

–

Contact for public queries

Prof. Dr. Elmar Graessel (elmar.graessel@uk-erlangen.de)

Contact for scientific queries

Prof. Dr. Elmar Graessel (elmar.graessel@uk-erlangen.de)

Public title

MAKS-s – multimodal psychosocial intervention for people with severe dementia in inpatient care: a cluster-randomized controlled trial

Scientific title

MAKS-s – multimodal psychosocial intervention for people with severe dementia in inpatient care: a cluster-randomized controlled trial assessing the effects on behavioral and psychological symptoms, quality of life, and activities of daily living of people with severe dementia as well as caregiver burden

Countries of recruitment

Germany

Health condition(s) or problem(s) studied

severe dementia, professional care team burden

Intervention(s)

Intervention group: psychosocial group intervention

Control group: treatment as usual

1.Key inclusion and exclusion criteria

Ages eligible for study: senior; Sexes eligible for study: all

Inclusion criteria: 1. Psychometric verification of severe dementia syndrome: Mini Mental State Examination (MMSE) Score between 0 and 9

2. Informed consent for study participation.

Exclusion criteria: 1. Mild to moderate dementia respectively no cognitive impairment (MMSE > 9)

2. Cognitive decline due to diseases other than dementia (e.g. schizophrenia or Korsakoff)

3. Severe hearing impairment

4. Severe visual impairment

5. Permanently bedridden persons

6. History of severe major depression

7. History of more than one stroke

8. No verbal communication in German possible

Study type

Cluster-randomized controlled multi-center intervention study

Date of first enrollment

01/12/2019

Target sample size

144

Recruitment status

ongoing

Primary outcome(s)

1. Quality of life, measured by QUALIDEM

2. Behavioural and psychological symptoms of dementia, measured by Neuropsychiatric Inventory Nursing Home Version (NPI-NH)

Key secondary outcomes

1. Activities of daily living measured by ADCS-ADL-severe 2. Dementia-related caregiver burden of the nursing and care staff, measured by Professional Care Team Burden Scale (PTCB) 3. Days of incapacity for work of nursing and care staff, measured by documentation of the employer 4. Extent of implementation and voluntary continuation of the intervention in follow-up period, measured by a self-developed questionnaire