Effective Strategies for Dementia Care (WISDE)

August 30, 2011 updated by: Johann Behrens, Martin-Luther-Universität Halle-Wittenberg

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Design:

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

Study Type

Interventional

Enrollment (Actual)

327

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • SAN
      • Halle, SAN, Germany, 06097
        • Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Apathy Evaluation Scale (Marin et al. 1991)
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Johann Behrens, PhD, Martin-Luther-University Halle-Wittenberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

April 2, 2008

First Submitted That Met QC Criteria

April 4, 2008

First Posted (Estimate)

April 7, 2008

Study Record Updates

Last Update Posted (Estimate)

August 31, 2011

Last Update Submitted That Met QC Criteria

August 30, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PfVMS-T6

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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