Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00000395

Trial Description

start of 1:1-Block title

Title

The effect of an ADL orientated practical activation of demented persons in a home setting by informed caregivers and cognitiv activation by external personal in a home setting- a multicenter, randomised controlled trial for the evaluation of a multimodal, manual based and tailor-made activation programme.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ANAA+KO

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.anaa-und-ko.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In cooperation with community nursing services the research project ANAA+KO inverstigates the effect of a multimodal activation for persons with slight to medium dementia in a home setting.
In the course of this it is to measure, if these multimodal, home setting based and tailor-made activation will improve the practical and cognitive abilities during the 6 month intervention period, whereas they will continue to deteriorate in the control group. The informed caregiver will take over the ADL based practical activation in the home setting on six days a week for 60 minutes. Cognitiv activation takes place also in the home setting, but once a week, lasting 30 minutes and is performed by external personal, who are project staff of the Catholic University of Applied Sciences Mainz. Additionally, the informed caregivers receive continuous step by step training and are individually counselled by specially trained nurses from cooperating community services or project staff of the Catholic University of Applied Sciences Mainz.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The ANAA+KO project is a multicentre study in a randomised controlled design and a total sample of 117 subjects with slight to medium dementia. It investigates the effect of a multimodal (ADL orientated practical and cognitiv) and tailor- made activation in the home setting over 6 months intervention period.
It is expectet that, in comparison to the control group, the practical and cognitiv abilities in the intervention group will have improves after an intervention period of 6 months or will be constant in the pre-post-analysis. Outcome measures are functional abilities (E-ADL- Test) and cognitive abilities (ADAS-cog). In addition, the extent of care dependency (PAS) and the geriatric symptoms including the instrumental functional abilities (NOSGER-scale) of the dementia sufferers will be measured, as well as the quality of life (WHOQol-BREF) and strain for the relatives (HPS).

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000395
  •   2010/05/11
  •   [---]*
  •   yes
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   17S06X09/ 17S06X11  (Bundesministerium für Bildung und Forschung)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F00 -  Dementia in Alzheimer's disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   ADL based practical activation by an informed caregiver and cognitive activation by an externally personal in a home setting.
    The informed caregiver will take over the ADL based practical activation in the home setting on 6 days a week for 60 minutes for an intervention period of 6 month. Cognitiv activation takes place also in the home setting, but once a week, lasting 30 minutes and is performed by external personal.
    Additionally, the informed caregivers receive 1-3 times a week continuous step by step training and are individually counselled by specially trained nurses from cooperating community services or project staff of the Catholic University of Applied Science Mainz.
  •   standard care (through the cooperating community nursing services), no special activation for a period of 6 month.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

First measuring point (t0 after screening) and second measuring point (t1) after an intervention period of 6 month. Third measuring point (t2) after 12 month:
Measuring of ADL- abitities (E-ADL-Test) and cognitive abitities (ADAS-cog-Test) for the patients.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

First measuring point (t0 after screening) and second measuring point (t1) after an intervention period of 6 month. Third measuring point (t2) after 12 month:
Measuring of extent of care dependency by use of scale (PAS) and geriatric symptoms included instrumental function abilities (questionnaire: NOSGER-scale) for the patients, quality of life (questionnaire:WHOQol-BREF) and strain for the informed caregivers (questionnaire:HPS)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2009/12/15
  •   117
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Diagnosed Alzheimer's disease according to the criterias of ICD-10/ DSM IV
Screeninginstruments are Mini-Mental-State-Examination (Score: >=12 and <=24), SIDAM + integrated HIS. (live with an informed caregiver)

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Diagnosed vascular dementia according to the criterias of ICD-10/DSM IV. Disagreed score of screening instruments. Reluctance of the informed caregiver to take over the practical activation, no possibility of activation because of disabilities, no compliance, excessive consumation of alcohol, drugs or medications, neurological or psychiatric diseases such as depressions, schizophrenia.

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Katholische Hochschule Mainz
    • Ms.  Prof. Dr.  Renate  Stemmer 
    • Saarstraße 3
    • 55122  Mainz
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Katholische Hochschule Mainz
    • Ms.  Eva  Quack 
    • Saarstraße 3
    • 55122  Mainz
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Katholische Hochschule Mainz
    • Ms.  Eva  Quack 
    • Saarstraße 3
    • 55122  Mainz
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung
    • Hannoversche Straße 28-30
    • 10115  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/01/27
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Quack E, Eichenseer B, Gräßel E, Schmid M, Stemmer R: Maintaining everyday practical and cognitive competencies in dementia sufferers in a home setting. Journal of Clinical Nursing 2010; 19: 99
  •   Gräßel, Elmar; Siebert, Jelena; Ulbrecht, Gudrun; Stemmer, Renate: Was leisten „nicht-medikamentöse“ Therapien bei Demenz? Ein Überblick über aktuelle Projekte. Informationsdienst Altersfragen. 40 (2013), 02, 9-16
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.