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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
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
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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.
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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.