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

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TimeSlips
Standard care activity program
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia focused on measuring Behavioral symptoms, Long-term care

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Landis Homes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TimeSlips group storytelling program

Standard care activity program

Arm Description

Outcomes

Primary Outcome Measures

Rates of psychotropic drug prescriptions for study participants.

Secondary Outcome Measures

Mood and behavior patterns

Full Information

First Posted
June 24, 2011
Last Updated
July 3, 2012
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01382693
Brief Title
Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia
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 Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Behavioral symptoms, Long-term care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TimeSlips group storytelling program
Arm Type
Experimental
Arm Title
Standard care activity program
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
TimeSlips
Other Intervention Name(s)
creative expression program, storytelling program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard care activity program
Intervention Description
Standard-of-care activities for the study site's skilled-nursing dementia Special Care Units.
Primary Outcome Measure Information:
Title
Rates of psychotropic drug prescriptions for study participants.
Time Frame
eight months
Secondary Outcome Measure Information:
Title
Mood and behavior patterns
Time Frame
eight months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: residence in one of two dementia special-care skilled nursing units at the study site clinical diagnosis of dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winona S Houser, BA
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel R George, PhD
Organizational Affiliation
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Landis Homes
City
Lititz
State/Province
Pennsylvania
ZIP/Postal Code
17543
Country
United States

12. IPD Sharing Statement

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

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