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Effective Strategies for Dementia Care (WISDE)

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Johann Behrens, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT00653731
First received: April 2, 2008
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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.

Resource links provided by NLM:

MedlinePlus related topics: Dementia
U.S. FDA Resources

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 ]

Enrollment: 327
Study Start Date: February 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Snoezelen © Behavioral: Snoezelen ©
Nursing individual intervention one time a week for 20 minutes
Experimental: Reminiscence Behavioral: structured reminiscence therapy
Individual nursing intervention: one time a week 20 minutes
Experimental: 10 min activation Behavioral: 10-minutes activation
Individual nursing intervention: two times a week for 10 minutes
Active Comparator: Talk 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
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

Additional Information:
Project home page  This link exits the ClinicalTrials.gov site

No publications provided by Martin-Luther-Universität Halle-Wittenberg

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johann Behrens, Professor, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT00653731     History of Changes
Other Study ID Numbers: PfVMS-T6
Study First Received: April 2, 2008
Last Updated: August 30, 2011
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

Additional relevant MeSH terms:
Dementia
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013