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CONNECT for Better Falls Prevention in VA Community Living Centers

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00836433
First received: February 2, 2009
Last updated: October 23, 2014
Last verified: October 2014
Results First Received: October 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Health Services Research
Condition: Accidental Falls
Interventions: Behavioral: CONNECT educational intervention
Behavioral: FALLS educational intervention

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FALLS Only

Traditional falls educational intervention

FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

CONNECT + FALLS

CONNECT intervention on relationship-building and communication

CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving

FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions


Participant Flow:   Overall Study
    FALLS Only     CONNECT + FALLS  
STARTED     361     328  
COMPLETED     349     321  
NOT COMPLETED     12     7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
FALLS Only

Traditional falls educational intervention

FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

CONNECT + FALLS

CONNECT intervention on relationship-building and communication

CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving

FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions

Total Total of all reporting groups

Baseline Measures
    FALLS Only     CONNECT + FALLS     Total  
Number of Participants  
[units: participants]
  361     328     689  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 6     42  ± 5     44  ± 5  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     361     328     689  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     307     285     592  
Male     54     43     97  
Region of Enrollment  
[units: participants]
     
United States     361     328     689  



  Outcome Measures
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1.  Primary:   Fall-related Process Measures   [ Time Frame: 6 months ]

2.  Secondary:   Change in Facility Fall Rates   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Cathleen Colon-Emeric
Organization: Durham VA GRECC
phone: 9192860411 ext 6777
e-mail: cathleen.colonemeric@va.gov


Publications of Results:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00836433     History of Changes
Other Study ID Numbers: EDU 08-417
Study First Received: February 2, 2009
Results First Received: October 9, 2014
Last Updated: October 23, 2014
Health Authority: United States: Federal Government