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NCT01540851 · ClinicalTrials.gov registry record · NA

Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial

A NA study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
NA
Development phase
308
Enrollment target

NCT01540851 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 308 participants.

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The verdict

NCT01540851, a NA study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
NA
Development phase
308 participants
Enrollment target

Study Summary

The objectives of this research are to: Conduct a proof of concept randomized controlled trial with up to 300 patients undergoing primary total knee replacement (TKA) at Brigham and Women's Hospital (BWH). The trial will compare a "Care Navigator" post-discharge intervention versus "Usual Care" post discharge management of patients undergoing TKA. The intervention will focus on the challenging process of transitions from the acute care hospital to inpatient or outpatient rehabilitation, and from inpatient rehabilitation to home. The principal goals of the trial are: 1. To establish whether "Care Navigator" intervention improves functional outcomes as compared with the "Usual Care" treatment six months after TKA surgery. 2. To establish whether "Care Navigator" intervention is cost effective six months after TKA surgery. The investigators hypothesize that: 1. Incorporating the Care Navigator role into the "Usual Care" treatment will increase TKA patients' rate of adherence to the rehabilitation protocol and improve functional outcomes. 2. Addition of a Care Navigator is cost-effective.

Interventions

  • BEHAVIORAL Care Navigator
  • OTHER Standard Post-Operative TKA Care

Trial Details

FieldValue
Enrollment Target 308 participants
Start Date 2011-07-24
Est. Completion 2014-05-10
Phase NA

Sponsor

Brigham and Women's Hospital

937 total trials

What the Registry Record Tells You About NCT01540851

The ClinicalTrials.gov registry entry for NCT01540851 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 308 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Care Navigator is the first listed.

NCT01540851 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01540851 about?

NCT01540851 is a clinical study titled "Adding Value in Knee Arthroplasty Post-total Knee Replacement (TKR) Care Navigator Trial". The objectives of this research are to: Conduct a proof of concept randomized controlled trial with up to 300 patients undergoing primary total knee replacement (TKA) at Brigham and Women's Hospital (BWH). The trial will compare a "Care Navigator" post-discharge intervention versus "Usual Care" pos...

What is the current status of trial NCT01540851?

This trial is currently completed. It is a NA study. The enrollment target is 308 participants. The study started on 2011-07-24. Estimated completion is 2014-05-10.

What interventions are being tested in trial NCT01540851?

The interventions under investigation include: Care Navigator (BEHAVIORAL), Standard Post-Operative TKA Care (OTHER).

Who is sponsoring clinical trial NCT01540851?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.