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Clinical Trials/ISRCTN15722923
ISRCTN15722923
Completed
未知

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

German National Association of the Statutory Health Insurance and Long-Term Care Insurance Funds (GKV-Spitzenverband)0 sites145 target enrollmentAugust 7, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Severe dementia (degenerative type, not solely vascular)
Sponsor
German National Association of the Statutory Health Insurance and Long-Term Care Insurance Funds (GKV-Spitzenverband)
Enrollment
145
Status
Completed
Last Updated
3 years ago

Overview

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)

Registry
who.int
Start Date
August 7, 2019
End Date
June 30, 2021
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

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

Eligibility 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

  • 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

Outcomes

Primary Outcomes

Not specified

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