Trial document




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  DRKS00003117

Trial Description

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Title

The effects of structured Relearning methods on Daily Living task performance of persons with Dementia - the multi-site randomised controlled REDALI-DEM trial

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Trial Acronym

REDALI-DEM

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URL of the Trial

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Brief Summary in Lay Language

The REDALI-DEM trial evaluates effects of two learning methods on the performance of important everyday tasks in 175 patients with mild to moderate dementia.

Primary outcome is the improvement of the task performance. Secondary outcomes are the need of assistance for basic and household activities of daily living, the acceptance of the treatment and resource utilisation of health services.

Patients will be treated 12 times within the first block of 10 weeks and will receive 3 refresher-sessions later on. The first intervention arm consists of task training using the method of active learning. Here the patient is allowed to make mistakes and to take initiative for correction. The second intervention arm uses the method of guided learning. Here the therapist intervenes and repeatedly demonstrates the correct performance before the patient can make a mistake.

Data are collected as follows: (1) dementia severity and further diagnoses as well as mood, alertness and socio-demographic data of the patient pre-treatment; (2) everyday functioning, cognition and challenging behaviour pre- and post-treatment and at a 4- and 6-months-follow-up; (3) costs and acceptance of the treatment as well as rate and reasons of dropouts.

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Brief Summary in Scientific Language

The REDALI-DEM trial evaluates effects of two learning methods on the performance of important everyday tasks in 175 patients with mild to moderate dementia.

Primary outcome is the improvement of the task performance. Secondary outcomes are the need of assistance for basic and household activities of daily living, the acceptance of the treatment and resource utilisation of health services.

Patients will be treated 12 times within the first block of 10 weeks and will receive 3 refresher-sessions later on. The first intervention arm consists of task training using the method of active learning. Here the patient is allowed to make mistakes and to take initiative for correction. The second intervention arm uses the method of guided learning. Here the therapist intervenes and repeatedly demonstrates the correct performance before the patient can make a mistake.

Data are collected as follows: (1) dementia severity and further diagnoses as well as mood, alertness and socio-demographic data of the patient pre-treatment; (2) everyday functioning, cognition and challenging behaviour pre- and post-treatment and at a 4- and 6-months-follow-up; (3) costs and acceptance of the treatment as well as rate and reasons of dropouts.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00003117
  •   2011/05/31
  •   [---]*
  •   yes
  •   Approved
  •   194/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F00 -  Dementia in Alzheimer's disease
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Interventions/Observational Groups

  •   10 weeks with 12 sessions a 60 min task training using the method of active learning. The patient is allowed to make mistakes and to take initiative for correction. 2 weeks with 3 refresher sessions a 60 min before the follow-up measurement in week 16.
  •   Task training with the same intensitiy using the method of guided learning. The therapist intervenes and repeatedly demonstrates the correct performance before the patient can make a mistake.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

Performance of two selected daily living tasks in week 0, 11, 16 (=primary measurement timepoint) and 26, assessed with the Task Performace Scale.

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Secondary Outcome

(a) Need of assistance for basic and household activities of daily living in week 0, 11, 16 and 26 assessed with the IDDD; (b) acceptance of treatment, assessed with the Verbal Rating Scale at each session; (c) costs of treatment assessed with the RUD.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2012/04/23
  •   175
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Persons diagnosed with Alzheimer's disease or mixed type dementia; Mini Mental State Examination: 14-24; Living at home; carer available for rating the need of assistance in activities of daily living; at least moderate need of assistance in instrumental activities of daily living; informed consent of patient and primary carer.

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Exclusion Criteria

Major depression, Geriatric Depression Scale (15 items) ≥ 9; major need of physical nursing care (level 2 or higher according to the German Long-Term Care Insurance Act indicated by 120 min or more per day); severe behavioural disturbances, unstable medical conditions or lack of attention and understanding of simple task instructions in German language, which do not allow participation in the study as judged by the recruiting study physician; involvement in other clinical trials

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Zentrum für Geriatrie und Gerontologie Freiburg, Universitätsklinikum Freiburg
    • Mr.  Sebastian  Voigt-Radloff 
    • Lehner Strasse 88
    • 79106  Freiburg
    • Germany
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    • Zentrum für Geriatrie und Gerontologie Freiburg, Universitätsklinikum Freiburg
    • Mr.  Sebastian  Voigt-Radloff 
    • Lehner Strasse 88
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/11/30
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Trial Publications, Results and other Documents

  •   1. Voigt-Radloff S, Leonhart R, Rikkert MO, Kessels R, Hüll M. Study protocol of the multi-site randomised controlled REDALI-DEM trial--the effects of structured relearning methods on daily living task performance of persons with dementia. BMC Geriatr. 2011 Aug 18;11:44.
  •   2. de Werd MM, Boelen D, Rikkert MG, Kessels RP. Errorless learning of everyday tasks in people with dementia. Clin Interv Aging. 2013;8:1177-90.
  •   3. de Werd MM, Hoelzenbein AC, Boelen DH, Rikkert MG, Hüell M, Kessels RP, Voigt-Radloff S. Interrater Reliability and Con-current Validity of a New Rating Scale to Assess the Perfor-mance of Everyday Life Tasks in Dementia: The Core Elements Method. Am J Alzheimers Dis Other Demen. 2016 Jun 14.
  •   4. Voigt-Radloff S, de Werd MM, Leonhart R, Boelen DH, Olde Rikkert MGM, Fliessbach K, Klöppel S, Heimbach B, Fellgiebel A, Dodel R, Eschweiler GW, Hausner L, Kessels RPC, Hüll M. Structured relearning of activities of daily living in dementia – the randomized controlled REDALI-DEM trial on errorless learning. Accepted in Feb. 2017 at Alzheimer Research & Therapy (AZRT-D-16-00115R2).
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* This entry means the parameter is not applicable or has not been set.