Condition category
Mental and Behavioural Disorders
Date applied
04/07/2014
Date assigned
30/07/2014
Last edited
30/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
To date, two thirds of people suffering from cognitive decline or dementia are cared for at home. Informal caregivers are often spouses, and a growing number of them are children of the affected person. These caregivers often have to work as well and suffer from the double work load. The DeTaMAKS project aims to find ways to reduce the burden for informal caregivers, helping them to cope with their joint care and home responsibilities though counselling, and offering a proven drug-free therapy called MAKS for those affected by dementia in day-care centres.

Who can participate?
Visitors of day-care centres with mild cognitive impairment or early dementia and their informal caregiver.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) receive the treatment. MAKS therapy involves a combination of physical activities, practice in “daily living” activities, cognitive stimulation exercises and a “spiritual element” - for example a group song or discussion of a topic. Participants in group 1 have daily sessions of MAKS therapy for six months. Those in group 2 (control group) receive their usual care offered by the day centre. Informal caregivers of those participants in group 1 are offered up to 3 telephone counselling sessions designed to help them develop strategies of stress management and how to cope with any challenging behavior from their affected relative.

What are the possible benefits and risks of participating?
Not provided at registration

Where is the study run from?
Fredrich Alexander University, Erlangen (Germany)

When is the study starting and how long is it expected to run for?
July 2014 to December 2016

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

Who is the main contact?
Dr Katharina Luttenberger
katharina.luttenberger@uk-erlangen.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Elmar Graessel

ORCID ID

Contact details

University Clinic Erlangen
Department of Psychiatry and Psychotherapy
Medical Psychology and Medical Sociology
Erlangen
91054
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GKV-SV201

Study information

Scientific title

Multimodal non-drug therapy for persons with cognitive decline in day-care institutions with short-term interventions for informal caregivers by telephone to strengthen the compatibility of care and work

Acronym

DeTaMAKS

Study hypothesis

1. Advancement of preventive and rehabilitative approaches. Compared with the control group (treatment as usual), “MAKS-T” will lead to improved stabilization of abilities in activities of daily living for people with dementia and to better preservation of independence.
2. Decreases in the stress caused by giving care for informal caregivers. Compared with the control group, the stress caused by caring for relatives will decrease with the administration of the combination of “MAKS-T” and the short intervention for family caregivers by telephone.
3. In the medium and long term, targets 1 and 2 will lead to an improvement in the compatibility of care and work and to an improvement in cost efficiency (day care instead of nursing home). The intervention will lead to a longer stay in day-care institutions, beginning with the two-year-data acquisition (which means that institutionalization will not be necessary because of the compatibility of care and work).

Ethics approval

Ethics board of the Friedrich-Alexander-University Erlangen-Nuremberg,03/06/2014. ref. 170_14 B

Study design

Cluster-randomised controlled intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Mild cognitive impairment, mild or moderate dementia (degenerative type, not solely vascular)

Intervention

Treatment consists of two parts:
1. Activation therapy for cognitively affected day-care visitors
1.a. Intervention group: The well-examined MAKS therapy (see http://www.biomedcentral.com/1741-7015/9/129) will be adapted to the day-care situation. During the intervention time of six months, MAKS therapy will be performed every day in the day care in groups of a maximum of 12 persons with two therapists. MAKS is a multicomponent group therapy consisting of tasks organised into three categories – motor stimulation (M), ADL (A), and cognition (K) – preceded by a short introduction to create a feeling of social cohesion within the group (S). Each daily session will begin with this introduction, which lasts approximately 10 minutes and was designed to help the dementia patients feel that they are a part of the group. This is followed by about 30 minutes of motor exercises, such as bowling, croquet, or balancing a tennis ball on a frisbee and passing it to one’s neighbour. After a 10 minute break, the patients spend approximately 30 minutes completing a variety of cognitive tasks, ranging from paper and pencil exercises, such as solving word jumbles or matching symbols in pairs, to picture puzzles projected digitally onto a large screen to be solved by the group. MAKS was designed to promote activities that take place at an individual’s performance limit. Therefore, therapists place all participants into three homogenous groups according to their individual performance levels (operationalised as their MMSE score) and assign the cognitive tasks from one of three difficulty levels to the appropriate group. This is followed by about 40 minutes during which patients carry out ADL (such as preparing a snack), engage in creative tasks (such as working with wood, paper, or other natural materials), or perform simple gardening work.
1.b. Control group: The control group receives the usual care offered in each day care (treatment as usual).
2. Telephone intervention for informal caregiver:
Each informal caregiver in the intervention groups will receive up to 3 telephone counselling sessions in which skilled psychologists help her or him to elaborate strategies of stress management and to cope with any challenging behaviour exhibited by the affected relative.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Abilities of daily living assessed at baseline and after 6 months:
Performance test E-ADL
2. Cognition assessed at baseline and after 6 months:
MMSE and MOCA

Secondary outcome measures

All assessed at baseline, after 6, 12, and 24 months
1. Life quality of informal caregiver and relative:
EQ-5 D questionnaire
2. Care Situation:
2.a. RUD Questionnare
2.b. FIMA
2.c. Health care utilisation
3. Caregiver Burden:
3.a. HPS-K
3.b. BIZA-D
4. Dementia symptoms
4.a. NPI-Q
4.b. NOSGER (social behaviour)

Overall trial start date

01/07/2014

Overall trial end date

31/12/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Visitors of day-care centres with mild cognitive impairment or early dementia who have an informal caregiver
2. Informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

350

Participant exclusion criteria

1. Completely blind or deaf
2. No informal caregiver at all
3. Severe dementia
4. Cognitive decline due to diseases other than dementia (e.g. schizophrenia or Korsakov)

Recruitment start date

01/07/2014

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Germany

Trial participating centre

University Clinic Erlangen
Erlangen
91054
Germany

Sponsor information

Organisation

Statutory Health Insurance Funds Association (GKV-Spitzenverband) (Germany)

Sponsor details

GKV-Spitzenverband
Dr. Christiane Eifert
GKV Spitzenverband
Reinhardtstr. 30
Berlin
10117
Germany

Sponsor type

Industry

Website

Funders

Funder type

Other

Funder name

German National Association of the Statutory Health Insurance and Long-Term Care Insurance Funds (GKV-Spitzenverband) reference No.: GKV-SV201(Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Bavarian State Ministry of Health and Care (Germany)

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

Publication citations

Additional files

Editorial Notes