NCT00653731

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
327

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

August 31, 2011

Status Verified

August 1, 2011

Enrollment Period

1.9 years

First QC Date

April 2, 2008

Last Update Submit

August 30, 2011

Conditions

Keywords

dementiasnoezelenstructured reminiscence therapy10-minutes activationapathy

Outcome Measures

Primary Outcomes (1)

  • Apathy Evaluation Scale (Marin et al. 1991)

    12 months

Secondary Outcomes (6)

  • Neuropsychiatric Inventory (Cummings 1997)

    3, 6 and 12 months

  • Apathy Evaluation Scale (Marin et al. 1991)

    3 and 6 months

  • Staff Observation Aggression Scale (Nijman et al. 1997)

    3,6 and 12 months

  • Nottingham Health Profile (Bureau-Chalot et al. 2002) staff-related measurement

    6 and 12 months

  • Smiley Analogue Scale for Well-Being

    3, 6 and 12 months

  • +1 more secondary outcomes

Study Arms (4)

Snoezelen ©

EXPERIMENTAL
Behavioral: Snoezelen ©

Reminiscence

EXPERIMENTAL
Behavioral: structured reminiscence therapy

10 min activation

EXPERIMENTAL
Behavioral: 10-minutes activation

Talk

ACTIVE COMPARATOR
Behavioral: Unstructured verbal communication

Interventions

Snoezelen ©BEHAVIORAL

Nursing individual intervention one time a week for 20 minutes

Snoezelen ©

Individual nursing intervention: one time a week 20 minutes

Reminiscence

Individual nursing intervention: two times a week for 10 minutes

10 min activation

Individual nursing intervention: one time a week for 20 minutes

Talk

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät, Martin-Luther-Universität Halle-Wittenberg

Halle, SAN, 06097, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DementiaCognitive DysfunctionLethargy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Johann Behrens, PhD

    Martin-Luther-University Halle-Wittenberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 2, 2008

First Posted

April 7, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

August 31, 2011

Record last verified: 2011-08

Locations