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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Winona Houser, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01382693
First received: June 24, 2011
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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 Intervention
Dementia
Behavioral: TimeSlips
Behavioral: Standard care activity program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Rates of psychotropic drug prescriptions for study participants. [ Time Frame: eight months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mood and behavior patterns [ Time Frame: eight months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • residence in one of two dementia special-care skilled nursing units at the study site
  • clinical diagnosis of dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01382693

Locations
United States, Pennsylvania
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
  More Information

No publications provided

Responsible Party: Winona Houser, Medical Student, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01382693     History of Changes
Other Study ID Numbers: 36459 EP
Study First Received: June 24, 2011
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Behavioral symptoms
Long-term care

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014