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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15722923

Enrollment

144

Registered

2019-08-07

Start date

2019-12-01

Completion date

Unknown

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe dementia (degenerative type, not solely vascular) Nervous System Diseases Dementia

Interventions

The intervention MAKS-s is a multimodal psychosocial group intervention for people with severe dementia. It is a further development of the evidence-based MAKS therapy for people with mild to moderate

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. Quality of life measured by QUALIDEM 2. Behavioural and psychological symptoms of dementia measured by Neuropsychiatric Inventory – Nursing Home Version (NPI-NH) Measured at t0 (baseline), t2 (2 months after baseline), t6 (6 months after baseline) Updated 15/01/2020: Measured at t0 (baseline), t2 (2 months after baseline), t6 (6 months after baseline), t12 (12 months after baseline)	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 27/05/2020: 1. Activities of daily living measured by ADCS-ADL-severe at t0 (baseline), t2 (2 months after baseline), t6 (6 months after baseline) 2. Dementia-related caregiver burden of the nursing and care staff, measured by Professional Care Team Burden Scale (PTCB) at t0 (baseline), t6 (6 months after baseline) 3. Days of incapacity for work of nursing and care staff, measured by documentation of the employer for the entire study period 4. Extent of implementation and voluntary continuation of the intervention in follow-up period, measured by a self-developed questionnaire at t12 (12 months after baseline) Previous secondary outcome measures: 1. Activities of daily living measured by Erlangen Test of Activities of Daily Living (E-ADL) at t0 (baseline), t2 (2 months after baseline), t6 (6 months after baseline) 2. Dementia-related caregiver burden of the nursing and care staff, measured by Professional Care Team Burden Scale (PTCB) at t0 (baseline), t6 (6 months after baseline) 3. Days of incapacity for work of nursing and care staff, measured by documentation of the employer for the entire study period Added 15/01/2020: 4. Extent of implementation and voluntary continuation of the intervention in follow-up period, measured by a self-developed questionnaire at t12 (12 months after baseline)	—

Measure

Time frame

Current secondary outcome measures as of 27/05/2020: 1. Activities of daily living measured by ADCS-ADL-severe at t0 (baseline), t2 (2 months after baseline), t6 (6 months after baseline) 2. Dementia-related caregiver burden of the nursing and care staff, measured by Professional Care Team Burden Scale (PTCB) at t0 (baseline), t6 (6 months after baseline) 3. Days of incapacity for work of nursing and care staff, measured by documentation of the employer for the entire study period 4. Extent of implementation and voluntary continuation of the intervention in follow-up period, measured by a self-developed questionnaire at t12 (12 months after baseline) Previous secondary outcome measures: 1. Activities of daily living measured by Erlangen Test of Activities of Daily Living (E-ADL) at t0 (baseline), t2 (2 months after baseline), t6 (6 months after baseline) 2. Dementia-related caregiver burden of the nursing and care staff, measured by Professional Care Team Burden Scale (PTCB) at t0 (baseline), t6 (6 months after baseline) 3. Days of incapacity for work of nursing and care staff, measured by documentation of the employer for the entire study period Added 15/01/2020: 4. Extent of implementation and voluntary continuation of the intervention in follow-up period, measured by a self-developed questionnaire at t12 (12 months after baseline)

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026