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

July 3, 2012 updated by: Winona Houser, Milton S. Hershey Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

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

  • United States
    • Pennsylvania
      • Lititz, Pennsylvania, United States, 17543
        • Landis Homes

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rates of psychotropic drug prescriptions for study participants.
Time Frame: eight months
eight months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mood and behavior patterns
Time Frame: eight months
eight months

Collaborators and Investigators

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

Sponsor

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 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

June 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

June 24, 2011

First Submitted That Met QC Criteria

June 24, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

July 4, 2012

Last Update Submitted That Met QC Criteria

July 3, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36459 EP

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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