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Clinical Trials/NCT00653731
NCT00653731CompletedNot Applicable

Testing Three Interventions for Clinical Effectiveness in Long Term Care Residents With Dementia: Snoezelen, Structured Reminiscence Therapy, 10-minutes Activation. A Cluster-randomized Controlled Trial.

Martin-Luther-Universität Halle-Wittenberg2 sites in 1 country327 target enrollmentStarted: February 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
327
Locations
2
Primary Endpoint
Apathy Evaluation Scale (Marin et al. 1991)

Study Overview

Brief Summary

The purpose of this study is to determine whether the interventions of Snoezelen, structured reminiscence therapy and 10-minutes activation are effective to reduce apathy in long term care residents with dementia.

Detailed Description

Design:

Cluster-randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
55 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Informed consent by legal guardian
  • MMSE ≤ 24

Exclusion Criteria

  • Korsakoff's syndrome
  • Age ≤ 55 years
  • Cognitive impairment other cause than dementia

Outcomes

Primary Outcomes

Apathy Evaluation Scale (Marin et al. 1991)

Time Frame: 12 months

Secondary Outcomes

  • Neuropsychiatric Inventory (Cummings 1997)(3, 6 and 12 months)
  • Apathy Evaluation Scale (Marin et al. 1991)(3 and 6 months)
  • Staff Observation Aggression Scale (Nijman et al. 1997)(3,6 and 12 months)
  • Nottingham Health Profile (Bureau-Chalot et al. 2002) staff-related measurement(6 and 12 months)
  • Smiley Analogue Scale for Well-Being(3, 6 and 12 months)
  • PASTA (Zimber 2001) staff-related measurement(6 and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Johann Behrens

Professor

Martin-Luther-Universität Halle-Wittenberg

Study Sites (2)

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