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Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers (TEAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008254
Recruitment Status : Completed
First Posted : November 5, 2009
Last Update Posted : October 19, 2011
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Tracey L. Yap, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE November 4, 2009
First Posted Date  ICMJE November 5, 2009
Last Update Posted Date October 19, 2011
Study Start Date  ICMJE September 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2009)		 Reduction of Facility Acquired Pressure Ulcers [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01008254 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 4, 2009)		 Organizational Change [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers
Official Title  ICMJE Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers
Brief Summary Musical reminder will raise compliance with mobility in the long-term care setting and reduce facility-acquired pressure ulcers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Pressure Ulcers
Intervention  ICMJE
  • Behavioral: 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 12 months.
  • Behavioral: Delayed 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.
  • Other: No musical prompt
    No intervention.
Study Arms  ICMJE
  • Experimental: Musical prompt
    Intervention: Behavioral: Musical prompt
  • Active Comparator: Delayed musical prompt
    Intervention: Behavioral: Delayed musical prompt
  • No Intervention: No musical prompt
    Intervention: Other: No musical prompt
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 29, 2011)		 2000
Original Estimated Enrollment  ICMJE
 (submitted: November 4, 2009)		 100
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Long-term care resident
  • MDS qualified

Exclusion Criteria:

  • Self pay long-term care residents
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01008254
Other Study ID Numbers  ICMJE #1007523
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tracey L. Yap, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE Robert Wood Johnson Foundation
Investigators  ICMJE
Principal Investigator: Tracey L Yap, RN, PhD University of Cincinnati College of Nursing
PRS Account University of Cincinnati
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP