NCT01008254

Brief Summary

Musical reminder will raise compliance with mobility in the long-term care setting and reduce facility-acquired pressure ulcers.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2009

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

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 19, 2011

Status Verified

October 1, 2011

Enrollment Period

1.7 years

First QC Date

November 4, 2009

Last Update Submit

October 18, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction of Facility Acquired Pressure Ulcers

    2 years

Secondary Outcomes (1)

  • Organizational Change

    2 years

Study Arms (3)

Musical prompt

EXPERIMENTAL
Behavioral: Musical prompt

Delayed musical prompt

ACTIVE COMPARATOR
Behavioral: Delayed musical prompt

No musical prompt

NO INTERVENTION
Other: No musical prompt

Interventions

Musical promptBEHAVIORAL

Repositioning and mobility education program administered to all facility staff combined with tailored musical prompt reminder that played every two hours, every day, during a 12 hour period, for 12 months.

Musical prompt

Repositioning and mobility education program administered to all facility staff combined with tailored musical prompt reminder that played every two hours, every day, during a 12 hour period, for 6 months.

Delayed musical prompt

No intervention.

No musical prompt

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Long-term care resident
  • MDS qualified

You may not qualify if:

  • Self pay long-term care residents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Yap TL, Kennerly SM, Simmons MR, Buncher CR, Miller E, Kim J, Yap WY. Multidimensional team-based intervention using musical cues to reduce odds of facility-acquired pressure ulcers in long-term care: a paired randomized intervention study. J Am Geriatr Soc. 2013 Sep;61(9):1552-9. doi: 10.1111/jgs.12422. Epub 2013 Aug 26.

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tracey L Yap, RN, PhD

    University of Cincinnati College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 5, 2009

Study Start

September 1, 2009

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 19, 2011

Record last verified: 2011-10