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Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia

Sponsor
Milton S. Hershey Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01382693
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
3
Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This project, a small-scale pilot study, will attempt to determine if involvement in a group-based creative expression program may correlate with a reduction in use of psychotropic drugs for persons with dementia.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: TimeSlips
  • Behavioral: Standard care activity program
 N/A

Detailed Description

The study site has two skilled-nursing dementia Special Care Units. One unit will serve as a control with residents receiving the standard care activity program. The other unit will receive the standard care activity program as well as the TimeSlips storytelling program (two hour-long sessions per week for six weeks). The behavioral symptoms and psychotropic drug usage for both cohorts will be studied for eight months, the first four months with no intervention and the last four months with or without the six-week TimeSlips intervention.

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia in Long-term Care: a Cluster-randomized Pilot Study
Study Start Date :
Jun 1, 2011
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: TimeSlips group storytelling program

Behavioral: TimeSlips
TimeSlips is a group-based creative storytelling program for people with dementia. The intervention will be held twice a week for six weeks, in hour-long sessions.
Other Names:
  • creative expression program
  • storytelling program

    		•
    Active Comparator: Standard care activity program

    Behavioral: Standard care activity program
    Standard-of-care activities for the study site's skilled-nursing dementia Special Care Units.

    Outcome Measures

    Primary Outcome Measures

    1. Rates of psychotropic drug prescriptions for study participants. [eight months]

    Secondary Outcome Measures

    1. Mood and behavior patterns [eight months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • residence in one of two dementia special-care skilled nursing units at the study site

    • clinical diagnosis of dementia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Landis Homes Lititz Pennsylvania United States 17543

    Sponsors and Collaborators

    • Milton S. Hershey Medical Center

    Investigators

    • Principal Investigator: Winona S Houser, BA, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
    • Study Director: Daniel R George, PhD, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Winona Houser, Medical Student, Milton S. Hershey Medical Center
    ClinicalTrials.gov Identifier:
    NCT01382693
    Other Study ID Numbers:
    • 36459 EP
    First Posted:
    Jun 27, 2011
    Last Update Posted:
    Jul 4, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by Winona Houser, Medical Student, Milton S. Hershey Medical Center
    Behavioral symptoms
    Long-term care
    Additional relevant MeSH terms:
    Dementia

    Study Results

    No Results Posted as of Jul 4, 2012