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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: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT01540851 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 308 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The change in functional status will be measured using the WOMAC Physical Function scale at Baseline and 6 months
Interventions
- BEHAVIORAL Care Navigator
- OTHER Standard Post-Operative TKA Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 308 participants |
| Start Date | 2011-07-24 |
| Est. Completion | 2014-05-10 |
| Phase | NA |
What the finished NCT01540851 record still lists
NCT01540851 is an interventional study that assigns participants to a tested intervention. The registered 308 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Care Navigator is the first listed.
NCT01540851 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01540851's enrollment target sits among peer trials
308 323rd of 2000 higher than 1,677 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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