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Effective Strategies for Dementia Care (WISDE)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Martin-Luther-Universität Halle-Wittenberg
German Federal Ministry of Education and Research
Information provided by: Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00653731
  Purpose

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.


Condition Intervention
Dementia
Cognitive Impairment
Behavioral: Snoezelen ©
Behavioral: structured reminiscence therapy
Behavioral: 10-minutes activation
Behavioral: Unstructured verbal communication

MedlinePlus related topics: Dementia
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: 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.

Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Apathy Evaluation Scale (Marin et al. 1991) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neuropsychiatric Inventory (Cummings 1997) [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • Apathy Evaluation Scale (Marin et al. 1991) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]
  • Staff Observation Aggression Scale (Nijman et al. 1997) [ Time Frame: 3,6 and 12 months ] [ Designated as safety issue: No ]
  • Nottingham Health Profile (Bureau-Chalot et al. 2002) staff-related measurement [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Smiley Analogue Scale for Well-Being [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
  • PASTA (Zimber 2001) staff-related measurement [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: February 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Snoezelen ©: Experimental Behavioral: Snoezelen ©
Nursing individual intervention one time a week for 20 minutes
Reminiscence: Experimental Behavioral: structured reminiscence therapy
Individual nursing intervention: one time a week 20 minutes
10 min activation: Experimental Behavioral: 10-minutes activation
Individual nursing intervention: two times a week for 10 minutes
Talk: Active Comparator Behavioral: Unstructured verbal communication
Individual nursing intervention: one time a week for 20 minutes

Detailed Description:

Design:

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

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dementia
  • Informed consent by legal guardian
  • MMSE ≤ 24

Exclusion Criteria:

  • Korsakoff's syndrome
  • Age ≤ 55 years
  • Cognitive impairment other cause than dementia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653731

Locations
Germany, SAN
Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg
Halle, SAN, Germany, 06097
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Johann Behrens, PhD Martin-Luther-University Halle-Wittenberg
  More Information

Project home page  This link exits the ClinicalTrials.gov site

Responsible Party: Martin-Luther-Universität Halle-Wittenberg ( Prof. Dr. phil habil Johann Behrens )
Study ID Numbers: PfVMS-T6
Study First Received: April 2, 2008
Last Updated: October 1, 2008
ClinicalTrials.gov Identifier: NCT00653731  
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
dementia
snoezelen
structured reminiscence therapy
10-minutes activation
apathy

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009