NCT01382693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

1 month

First QC Date

June 24, 2011

Last Update Submit

July 3, 2012

Conditions

Dementia

Keywords

Behavioral symptomsLong-term care

Outcome Measures

Primary Outcomes (1)

  • Rates of psychotropic drug prescriptions for study participants.

    eight months

Secondary Outcomes (1)

  • Mood and behavior patterns

    eight months

Study Arms (2)

TimeSlips group storytelling program

EXPERIMENTAL
Behavioral: TimeSlips

Standard care activity program

ACTIVE COMPARATOR
Behavioral: Standard care activity program

Interventions

TimeSlipsBEHAVIORAL

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.

Also known as: creative expression program, storytelling program
TimeSlips group storytelling program
Standard care activity programBEHAVIORAL

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

Standard care activity program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Landis Homes

Lititz, Pennsylvania, 17543, United States

Location

MeSH Terms

Conditions

DementiaBehavioral Symptoms

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Winona S Houser, BA

    Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

  • Daniel R George, PhD

    Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Student

Study Record Dates

First Submitted

June 24, 2011

First Posted

June 27, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2011

Study Completion

September 1, 2011

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

US(1)