Effective Strategies for Dementia Care (WISDE)
Primary Purpose
Dementia, Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Snoezelen ©
structured reminiscence therapy
10-minutes activation
Unstructured verbal communication
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia focused on measuring dementia, snoezelen, structured reminiscence therapy, 10-minutes activation, apathy
Eligibility 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
Sites / Locations
- Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Snoezelen ©
Reminiscence
10 min activation
Talk
Arm Description
Outcomes
Primary Outcome Measures
Apathy Evaluation Scale (Marin et al. 1991)
Secondary Outcome Measures
Neuropsychiatric Inventory (Cummings 1997)
Apathy Evaluation Scale (Marin et al. 1991)
Staff Observation Aggression Scale (Nijman et al. 1997)
Nottingham Health Profile (Bureau-Chalot et al. 2002) staff-related measurement
Smiley Analogue Scale for Well-Being
PASTA (Zimber 2001) staff-related measurement
Full Information
NCT ID
NCT00653731
First Posted
April 2, 2008
Last Updated
August 30, 2011
Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00653731
Brief Title
Effective Strategies for Dementia Care
Acronym
WISDE
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 Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Martin-Luther-Universität Halle-Wittenberg
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Design:
Cluster-randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Cognitive Impairment
Keywords
dementia, snoezelen, structured reminiscence therapy, 10-minutes activation, apathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
327 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Snoezelen ©
Arm Type
Experimental
Arm Title
Reminiscence
Arm Type
Experimental
Arm Title
10 min activation
Arm Type
Experimental
Arm Title
Talk
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Snoezelen ©
Intervention Description
Nursing individual intervention one time a week for 20 minutes
Intervention Type
Behavioral
Intervention Name(s)
structured reminiscence therapy
Intervention Description
Individual nursing intervention: one time a week 20 minutes
Intervention Type
Behavioral
Intervention Name(s)
10-minutes activation
Intervention Description
Individual nursing intervention: two times a week for 10 minutes
Intervention Type
Behavioral
Intervention Name(s)
Unstructured verbal communication
Intervention Description
Individual nursing intervention: one time a week for 20 minutes
Primary Outcome Measure Information:
Title
Apathy Evaluation Scale (Marin et al. 1991)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Neuropsychiatric Inventory (Cummings 1997)
Time Frame
3, 6 and 12 months
Title
Apathy Evaluation Scale (Marin et al. 1991)
Time Frame
3 and 6 months
Title
Staff Observation Aggression Scale (Nijman et al. 1997)
Time Frame
3,6 and 12 months
Title
Nottingham Health Profile (Bureau-Chalot et al. 2002) staff-related measurement
Time Frame
6 and 12 months
Title
Smiley Analogue Scale for Well-Being
Time Frame
3, 6 and 12 months
Title
PASTA (Zimber 2001) staff-related measurement
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johann Behrens, PhD
Organizational Affiliation
Martin-Luther-University Halle-Wittenberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg
City
Halle
State/Province
SAN
ZIP/Postal Code
06097
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
20113526
Citation
Berg A, Sadowski K, Beyrodt M, Hanns S, Zimmermann M, Langer G, Becker C, Lautenschlager C, Behrens J. Snoezelen, structured reminiscence therapy and 10-minutes activation in long term care residents with dementia (WISDE): study protocol of a cluster randomized controlled trial. BMC Geriatr. 2010 Jan 31;10:5. doi: 10.1186/1471-2318-10-5.
Results Reference
derived
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Effective Strategies for Dementia Care
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