Condition category
Nervous System Diseases
Date applied
11/07/2019
Date assigned
07/08/2019
Last edited
07/08/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
There are currently very few therapies available for people with severe dementia. Therefore, the multimodal, psychosocial, evidence-based MAKS therapy for people with mild to moderate dementia and mild cognitive impairment should be adapted to the needs of people with severe dementia. The main objective of MAKS-s is a reduction of behavioral and psychological symptoms as well as an improvement in the quality of life in people with severe dementia by means of satisfaction of elementary basic needs. Furthermore, by attending the intervention MAKS-s a significantly better development of activities of daily living in people with dementia. As well a significant reduction in the caregiver burden of nursing and care staff should be achieved.. A relevant reduction in the number of days of incapacity to work is also assumed.

Who can participate?
People with severe dementia who living in a nursing home within Germany can participate. There is no restriction regarding age or gender. People with the following conditions cannot participate in the study: mild to moderate dementia respectively no cognitive impairment, severe hearing and/or severe visual impairment, cognitive decline due to diseases other than dementia (e.g. schizophrenia or Korsakov), permanently immobile,

What does the study involve?
The intervention MAKS-s is a multimodal psychosocial group intervention for people with severe dementia. It is a further development of evidence-based MAKS therapy for people with mild to moderate dementia and mild cognitive impairment.
The intervention MAKS-s was developed based on scientific findings on the progression of degenerative dementia and the special physiological conditions of people with severe dementia. The concept takes the basic needs of people with severe dementia into account. It consists of the modules motor stimulation (M), activities of daily living (A) and cognition (K for the German word “Kognition”) as well as social communicative attunement (S) aimed at people with severe (s) dementia. Compared to the original MAKS therapy, the modules of MAKS-s are clearly modified and adapted to the special requirements of people with severe dementia. For example, a MAKS-s unit lasts only one hour in order to take into account the lower attention span of people with severe dementia. In the social module (S), in contrast to MAKS therapy, biographical conversations are removed due to the severe limitations of autobiographical memory. In the motor stimulation module (M), more attention is paid to the promotion of body perception and contracture prophylaxis than to complex movement sequences and coordination. In the cognitive module (K), due to the advanced reduction in cortical performance in people with severe dementia, higher cognitive processes cannot be attained. Instead, multisensory stimulation is used to address and activate memory contents that are far in the past and mostly unconscious. Especially the cortex areas, which are little affected by Alzheimer's dementia, such as the somatosensory cortex, which processes sensory impressions of the sense of touch and the depth sensitivity. In the activities of daily living module (A), instead of complex everyday actions, basal processes, such as applying cream to hands or cut fruit, are used.
In the intervention group, MAKS-s is provided in each participating nursing home as a group offer on three days a week, for six months, with six people with severe dementia per institution. A standardized manual will be made available to the facilities, which will ensure a largely uniform implementation in all participating facilities. The implementation is controlled by monitoring visits. Participants will be examined with regard to the main and secondary outcomes before and after the intervention (6 months later) as well as 2 months after the intervention start. The main outcomes are behavioral and psychological symptoms and quality of life, secondary outcomes are activities of daily living, dementia-related caregiver burden of nursing and care staff, and days of incapacity for work of nursing and care staff. Of the 24 Nursing Homes in Germany collaborating in the study, 12 will perform the intervention MAKS-s immediately (intervention group); the others 6 months later (waiting control group).

What are the possible benefits and risks of participating?
The possible benefits of participating in the study are positive effects on behavioral and psychological symptoms, quality of life, and activities of daily living in people with severe dementia. Furthermore, reduced dementia-related caregiver burden of nursing and care staff, as well as less days of incapacity for work, are expected. No side effects are expected in the study.

Where is the study run from?
The study is run from the Center for Health Services Research in Medicine of the Department of Psychiatry and Psychotherapy of the Universitätsklinikum Erlangen (University Hospital Erlangen).

When is the study starting and how long is it expected to run for?
The study starts on the 01/07/2019 and will start with participant recruitment in 01/01/2020. The end of the trial is the 31/12/2020.

Who is funding the study?
The main sponsor is the German National Association of the Statutory Health Insurance and Long-Term Care Insurance Funds (GKV-Spitzenverband)

Who is the main contact?
For further information, please contact the study supervisor: Prof. Dr. Elmar Gräßel (Mail: elmar.graessel@uk-erlangen.de).

Trial website

Contact information

Type

Scientific

Primary contact

Prof Elmar Gräßel

ORCID ID

Contact details

Schwabachanlage 6
Erlangen
91054
Germany

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

GKV-SV339

Study information

Scientific title

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.

Acronym

MAKS-s

Study hypothesis

Primary hypothesis:
1. Compared to the control group (treatment as usual), the intervention MAKS-s will lead to a significantly better development of behavioral and psychological symptoms as well as quality of life in people with severe dementia in the intervention group.

Secondary hypotheses:
2. Compared to the control group (treatment as usual), the intervention MAKS-s will lead to a significantly better development of activities of daily living in people with severe dementia in the intervention group.
3. Compared to the control group (treatment as usual), the intervention MAKS-s will lead to a significantly better development of dementia-related caregiver burden of the nursing and care staff in the intervention group.
4. Compared to the control group (treatment as usual), the intervention MAKS-s will lead to a relevant reduction in days of incapacity for work of nursing and care staff in the intervention group due to better development of dementia-related caregiver burden, expected in hypothesis 3.

Ethics approval

Approval pending, Ethics Committee of the Medical Faculty of Friedrich-Alexander University Erlangen-Nürnberg (Geschäftsstelle der Ethikkommission, Krankenhausstr. 12, 91054 Erlangen; ethikkommission@fau.de; +4991318522270)

Study design

Cluster-randomized controlled multi-center intervention study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Severe dementia (degenerative type, not solely vascular)

Intervention

The intervention MAKS-s is a multimodal psychosocial group intervention for people with severe dementia. It is a further development of the evidence-based MAKS therapy for people with mild to moderate dementia and mild cognitive impairment (see http://www.biomedcentral.com/1741-7015/9/129 and https://www.aerzteblatt.de/int/archive/article/
195559/Non-pharmacological-treatment-in-people-with-cognitive-impairment-results-from-the-randomized-controlled-German-Day-Care-Study).

The intervention MAKS-s was developed based on scientific findings on the progression of degenerative dementia and the special physiological conditions of people with severe dementia. The concept takes the basic needs of people with severe dementia into account. It consists of the modules motor stimulation (M), activities of daily living (A) and cognition (K for the german word “Kognition”) as well as social communicative attunement (S) aimed at people with severe (s) dementia. Compared to the original MAKS therapy, the modules of MAKS-s are clearly modified and adapted to the special requirements of people with severe dementia. For example, a MAKS-s unit lasts only one hour in order to take into account the lower attention span of people with severe dementia. In the social module, in contrast to MAKS therapy, biographical conversations are removed due to the severe limitations of autobiographical memory. In the motor stimulation module (M), more attention is paid to facilitate body perception and contracture prophylaxis than to complex movement sequences and coordination. In the cognitive module (K), due to the advanced reduction of cortical performance in people with severe dementia, higher cognitive processes cannot be attained. Instead, multisensory stimulation is used to address and activate memory contents that are far in the past and mostly unconscious. Especially the cortex areas, which are little affected by Alzheimer's dementia, such as the somatosensory cortex, which processes sensory impressions of the sense of touch and the depth sensitivity. In the activities of daily living module (A), instead of complex everyday actions, basal processes, such as applying cream to hands or cut a fruit, are used.

In the intervention group, MAKS-s is provided in each participating nursing home as a group offer on three days a week, for six months, with six people with severe dementia per institution. A standardized manual will be made available to the facilities, which will ensure a largely uniform implementation in all participating facilities. The implementation is controlled by monitoring visits.

Of the 24 Nursing Homes in Germany collaborating in the study, 12 will perform the intervention MAKS-s immediately (intervention group); the others 6 months later (waiting control group).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Quality of life (measured by QUALIDEM)
2. Behavioural and psychological symptoms of dementia (measured by Neuropsychiatric Inventory – Nursing Home Version, NPI-NH).
Measured at t0 (baseline), t2 (2 months after baseline), t6 (6 months after baseline):

Secondary outcome measures

1. Activities of daily living (measured by Erlangen Test of Activities of Daily Living, E-ADL).t0 (baseline), t2 (2 months after baseline), t6 (6 months after baseline).
2. Dementia-related caregiver burden of the nursing and care staff (measured by Professional Care Team Burden Scale, PTCB), t0 (baseline), t6 (6 months after baseline).
3. Days of incapacity for work of nursing and care staff (measured by documentation of the employer), for the entire study period.

Overall trial start date

01/07/2019

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

144 people with severe dementia (participants) in 24 nursing homes (clusters)

Participant 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

Recruitment start date

01/12/2019

Recruitment end date

31/01/2020

Locations

Countries of recruitment

Germany

Trial participating centre

Universitätsklinikum Erlangen, Department of Psychiatry and Psychotherapy, Center for Health Services Research in Medicine
Schwabachanlage 6
Erlangen
91054
Germany

Sponsor information

Organisation

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

Sponsor details

Reinhardtstraße 28
Berlin
10117
Germany

Sponsor type

Other

Website

https://gkv-spitzenverband.de

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/07/2019: Trial’s existence confirmed by German National Association of the Statutory Health Insurance and Long-Term Care Insurance Funds (GKV-Spitzenverband)