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

Not Applicable

Completed

• Conditions: Severe dementia (degenerative type, not solely vascular); Nervous System Diseases; Dementia

• Registration Number: ISRCTN15722923
• Lead Sponsor: German National Association of the Statutory Health Insurance and Long-Term Care Insurance Funds (GKV-Spitzenverband)

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33059610/ protocol (added 22/10/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36577973/ (added 29/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-07
• Study Completion: 2021-06-30
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 145

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 & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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