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Effective Strategies for Dementia Care (WISDE)

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ClinicalTrials.gov Identifier: NCT00653731
Recruitment Status : Completed
First Posted : April 7, 2008
Last Update Posted : August 31, 2011
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Johann Behrens, Martin-Luther-Universität Halle-Wittenberg

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.

Condition or disease Intervention/treatment Phase
Dementia Cognitive Impairment Behavioral: Snoezelen © Behavioral: structured reminiscence therapy Behavioral: 10-minutes activation Behavioral: Unstructured verbal communication Not Applicable

Detailed Description:

Design:

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 327 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : February 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Apathy Evaluation Scale (Marin et al. 1991) [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Neuropsychiatric Inventory (Cummings 1997) [ Time Frame: 3, 6 and 12 months ]
  2. Apathy Evaluation Scale (Marin et al. 1991) [ Time Frame: 3 and 6 months ]
  3. Staff Observation Aggression Scale (Nijman et al. 1997) [ Time Frame: 3,6 and 12 months ]
  4. Nottingham Health Profile (Bureau-Chalot et al. 2002) staff-related measurement [ Time Frame: 6 and 12 months ]
  5. Smiley Analogue Scale for Well-Being [ Time Frame: 3, 6 and 12 months ]
  6. PASTA (Zimber 2001) staff-related measurement [ Time Frame: 6 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: August 31, 2011
Last Verified: August 2011

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

Additional relevant MeSH terms:
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders