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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00653731
Other study ID # PfVMS-T6
Secondary ID
Status Completed
Phase N/A
First received April 2, 2008
Last updated August 30, 2011
Start date February 2008
Est. completion date January 2010

Study information

Verified date August 2011
Source Martin-Luther-Universität Halle-Wittenberg
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Education and Research
Study type Interventional

Clinical Trial 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.


Description:

Design:

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


Recruitment information / eligibility

Status Completed
Enrollment 327
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 55 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Snoezelen ©
Nursing individual intervention one time a week for 20 minutes
structured reminiscence therapy
Individual nursing intervention: one time a week 20 minutes
10-minutes activation
Individual nursing intervention: two times a week for 10 minutes
Unstructured verbal communication
Individual nursing intervention: one time a week for 20 minutes

Locations

Country Name City State
Germany Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg Halle SAN

Sponsors (2)

Lead Sponsor Collaborator
Martin-Luther-Universität Halle-Wittenberg German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Apathy Evaluation Scale (Marin et al. 1991) 12 months No
Secondary Neuropsychiatric Inventory (Cummings 1997) 3, 6 and 12 months No
Secondary Apathy Evaluation Scale (Marin et al. 1991) 3 and 6 months No
Secondary Staff Observation Aggression Scale (Nijman et al. 1997) 3,6 and 12 months No
Secondary Nottingham Health Profile (Bureau-Chalot et al. 2002) staff-related measurement 6 and 12 months No
Secondary Smiley Analogue Scale for Well-Being 3, 6 and 12 months No
Secondary PASTA (Zimber 2001) staff-related measurement 6 and 12 months No
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