MAKS aktiv! Multi-modal activating therapy for dementia patients in nursing homes (activating therapy concerning everyday activities, exercise, cognitive and spiritual elements)

Completed

• Conditions: Dementia; Mental and Behavioural Disorders; Unspecified dementia

• Registration Number: ISRCTN87391496
• Lead Sponsor: German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-16
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

102 inhabitants of 5 nursing homes in Germany:
1. Existence of an degenerative dementia syndrome (diagnosed by a physician according to International Classification of Diseases, version 10 [ICD-10])
2. Mini-Mental State Examination (MMSE): value less than 24 points
3. Level of care of 0, 1 or 2 (not 3) according to the criteria of the German Health Insurance companies
4. Existence of an informed consent of the patient or his/her legal guardian

Exclusion Criteria

1. Psychiatric-neurological disease other than dementia that explains the cognitive impairment (e.g. schizophrenia)
2. Purely vascular dementia (diagnosed by physician)
3. Level of care equals 3
4. Blindness
5. Deafness
6. Being bed-ridden
7. Other severe obstacle for participating in the intervention group

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Competences in activities of daily living (ADL) operationalised with the Erlangen Test of Activities of Daily Living (E-ADL Test); score (0 = no ADL function, 30 = normal ADL function)<br>2. Cognitive abilities operationalised with the cognitive subtest of the Alzheimer's Disease Assessment Scale (ADAS-kog); score (0 = no cognitive impairment, 70 = severe impairment)<br><br>Primary and secondary outcome measures are collected for every participant individually in the week before (t0) and after (t1) the six months intervention period. For most of the participants the first measurements is from 20th to 31st October (t0) and again from 4th to 15th of May (t1). Participants who join the project at a later date to replace another participant who had to be excluded will have their t0 in the months of November 2008 until May 2009 and their t1 six months later, at the latest in November 2009.