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

Dementia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382693
• Other study ID #: 36459 EP
• Status: Completed
• Phase: N/A
• First received: June 24, 2011
• Last updated: July 3, 2012
• Start date: June 2011
• Est. completion date: September 2011

Study information

• Verified date: July 2012
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

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

• clinical diagnosis of dementia

Study Design

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

Related Conditions & MeSH terms

• Dementia

Intervention

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

Locations

Country	Name	City	State
United States	Landis Homes	Lititz	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of psychotropic drug prescriptions for study participants.		eight months	No
Secondary	Mood and behavior patterns		eight months	No