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Non-pharmacological, psychosocial MAKS® intervention for people with dementia in Chinese nursing homes

SinoMAKS - a randomised controlled study to test the efficacy of the Chinese version of the non-pharmacological, multimodal MAKS® intervention for the treatment of degenerative dementia in mild and moderate stages

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN10262531
Enrollment
200
Registered
2024-09-06
Start date
2024-10-14
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Dementia Mental and Behavioural Disorders

Interventions

The nursing home residents who are suitable for participation in the study according to the screening and who agree to participate in the study are randomly allocated to intervention and control group

Sponsors

Jiangsu Jicui Aging Research Institute of Technology Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Criteria of the dementia syndrome according to International Classification of Diseases (ICD)-10 2. Mild to moderate dementia: 9 < Mini Mental State Examination (MMSE) score < 24 3. Basic language skills as well as reading and spelling skills (Chinese) 4. Informed consent given

Exclusion criteria

Exclusion criteria: Current participant exclusion criteria as of 17/03/2025: 1. Completely blind or deaf 2. Permanently unable to get out of bed/immobile 3. Did not graduate from elementary school, i.e. less than 6 years in elementary school 4. Unable to communicate (does not respond to simple closed questions) 5. Diagnosis of another disease that causes cognitive impairment: 5.1. Vascular events (e.g. multiple strokes) 5.2. Parkinson’s disease 5.3. Multiple sclerosis 5.4. Severe brain disease (e.g. tumor, injury, hydrocephalus) 5.5. Psychosis (e.g. schizophrenia, mania, bipolar psychosis) 5.6. Severe depression 5.7. Alcohol abuse/drug consumption (addiction) or Korsakoff syndrome 6. Concrete plans/vision to move out of the nursing home Previous participant exclusion criteria: 1. Completely blind or deaf 2. Permanently unable to get out of bed/immobile 3. Did not graduate from elementary school, i.e. less than 6 years in elementary school 4. Unable to communicate (does not respond to simple closed questions) 5. Diagnosis of another disease that causes cognitive impairment: 5.1. Vascular events (e.g. multiple strokes) 5.2. Parkinson’s disease 5.3. Multiple sclerosis 5.4. Severe brain disease (e.g. tumor, injury, hydrocephalus) 5.5. Psychosis (e.g. schizophrenia, mania, bipolar psychosis) 5.6. Depression 5.7. Alcohol abuse/drug consumption (addiction) or Korsakoff syndrome 6. Concrete plans/vision to move out of the nursing home

Design outcomes

Primary

MeasureTime frame
Cognition measured by the validated Chinese version of the Addenbrooke's Cognitive Examination-III (ACE-III) at baseline and after 6 and 12 months

Secondary

MeasureTime frame
1. Behavioral and psychological symptoms agitation and aggression measured by the validated Chinese version of the Cohen-Mansfield Agitation Inventory – Short Form (CMAI-SF) at baseline and after 6 and 12 months 2. Activities of daily living measured by the Erlangen Test of Activities of Daily Living – Chinese version (E-ADL-CN) at baseline and after 6 and 12 months (Note: the E-ADL-CN is a newly developed, cultural adapted form of the Erlangen Test of Activities of Daily Living, being validated before the start of the study in people with dementia in Chinese nursing homes) 3. Clinical global impression measured by the two scales Clinical Global impression-severity score (CGI-S) and the Clinical Global impression-improvement (CGI-I) score at baseline and after 6 and 12 months

Countries

China

Contacts

Public ContactElmar;Yu Graessel;Liu

;

elmar.graessel@fau.de;liuyubmu@163.com+49 (0)913185-34142;+86 (0)18640068209

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026