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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 26, 2014