Condition category
Mental and Behavioural Disorders
Date applied
27/11/2008
Date assigned
16/01/2009
Last edited
12/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.maks-aktiv.de

Contact information

Type

Scientific

Primary contact

Prof Elmar Gräßel

ORCID ID

Contact details

University Hospital Erlangen
Clinic for Psychiatry and Psychotherapy
Schwabachanlage 6
Erlangen
91054
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LT-DEMENZ-44-059

Study information

Scientific title

Multi-modal activating therapy for dementia patients in nursing homes: a randomised controlled trial with an intervention group (standard care plus non-pharmacological activating therapy) and a control group (standard care)

Acronym

MAKS aktiv!

Study hypothesis

Principal aim of the study:
To prove the effectiveness of an intensive intervention consisting of everyday activities, cognitive, motor and exercise elements on dementia patients' cognitive and activities of daily living (ADL) capacities in five nursing homes.

Principal hypothesis:
In the 6 months observation period the multi-modal activating therapy results in significantly better cognitive and ADL capacities within the intervention group compared to the control group in the way that the capacities of the intervention group remain on average on their initial level, whereas the control groups' capacities decrease according to the disease's progression.

As of 30/07/09 this trial has been updated. Please note that recruitment for this trial has been completed. Patients wishing to learn more about the trial may use the contact details below to request more information or get informed at the trial's official website http://www.maks-aktiv.de

Ethics approval

Ethics committee of the Faculty of Medicine of the University Erlangen Nuremberg gave approval on 10th July 2008 (ref: 3232)

Study design

Multicentre randomised controlled single-blind intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dementia

Intervention

Intervention:
Multi-modal activating therapy, consisting of everyday activities, exercise, cognitive and spiritual elements, in five groups of ten persons each, two hours per day, six days per week, for at least six months.

Control:
Standard care (no changes in the care situation).

Baseline data (t0) is collected directly before the 6 months intervention period. After the 6 months the first follow up outcome data (t1) is collected. Further follow ups are planned at 1.5 and 2.5 years after t1. This design is equivalent for all treatment arms (intervention and control group).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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)
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)

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.

Secondary outcome measures

1. Instrumental Activities of Daily Living (IADL) operationalised with the subscale IADL of the Nurses Observation Scale for Geriatric Patients (NOSGER); score (5 = full IADL function, 25 = no IADL function)
2. Global geriatric symptomatology operationalised with the NOSGER cumulative value; score (30 = no impairment, 150 = severe impairment)
3. Level of nursing care dependency operationalised with the level of care according to the criteria of the German Health Insurance companies (no level of care = no care necessary, level 3 = highest level of care) and the Barthel-Index; score (0 = total care dependence, 100 = independent)
4. Care requirements and time cost operationalised with the Resource Utilisation in Dementia (RUD), items for ADL, IADL and supervision; score (time in minutes per day)

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.

Overall trial start date

01/09/2008

Overall trial end date

30/11/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

102 complete data sets, i.e. about 135 participants

Participant 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

Recruitment start date

01/09/2008

Recruitment end date

30/11/2009

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Erlangen
Erlangen
91054
Germany

Sponsor information

Organisation

German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany)

Sponsor details

c/o Dr. S. Gehring
Projektträger Gesundheitsforschung at the DLR
on behalf of the German Federal Ministry of Health
Heinrich-Konen-Str. 1
Bonn
53227
Germany

Sponsor type

Government

Website

http://www.bmg.bund.de/cln_117/nn_1168252/SharedDocs/Standardartikel/DE/AZ/L/Glossarbegriff-Leuchtturmprojekt-Demenz.html

Funders

Funder type

Government

Funder name

German Federal Ministry of Health (Bundesministerium fur Gesundheit [BMG]) (Germany) (ref: LT Demenz 44-059)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22468985
2. 2012 follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/23217188

Publication citations

  1. Results

    Luttenberger K, Donath C, Uter W, Graessel E, Effects of multimodal nondrug therapy on dementia symptoms and need for care in nursing home residents with degenerative dementia: a randomized-controlled study with 6-month follow-up., J Am Geriatr Soc, 2012, 60, 5, 830-840, doi: 10.1111/j.1532-5415.2012.03938.x.

  2. Luttenberger K, Hofner B, Graessel E, Are the effects of a non-drug multimodal activation therapy of dementia sustainable? Follow-up study 10 months after completion of a randomised controlled trial., BMC Neurol, 2012, 12, 151, doi: 10.1186/1471-2377-12-151.

Additional files

Editorial Notes