Nurse Led Follow-up After Total Knee Arthroplasty (NFTKA)

June 2, 2015 updated by: Birte Oestergaard, University of Southern Denmark

Nurse Led Follow-up After Total Knee Arthroplasty - a Randomized Trial

The aim of this study is to determine the effect of nurse led follow-up following total knee arthroplasty in regard to physical function, health related quality of life and self-efficacy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Due to shorter hospitalization the patients early have to be responsible for their own rehabilitation. However, the patients experience a variety of health related problems in the rehabilitations period following total knee arthroplasty and they have difficulties transferring health related information to their home settings. Nurse led follow-up in the early rehabilitation period might improve the health status of the patients by improving their knowledge and skills to handle health related problems. No studies found has investigated the effect of nurse led follow-up in form of telephone call following total knee arthroplasty.

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Gentofte
      • Hellerup, Gentofte, Denmark, 2900
        • University Hospital Gentofte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • primary first-time total knee arthroplasty due to osteoarthrosis
  • followed conventional admission course and discharged ≤ 4 days after surgery
  • understand and talk Danish
  • signed informed consent

Exclusion Criteria:

  • in terminal phase of another serious illness such as i.e. cancer with expected lifetime less than 6 months
  • previous total hip replacement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: telephone follow-up
Nurse led follow-up in form of consultation by telephone 4 days and 2weeks after discharge, respectively as a supplement to conventional admission course.
Behavioral: Telephone follow-up
The consultation is structured by predefined themes relevant for identifying health related problems in regard to illness to give adequate education and counseling. The form of each consultation will vary according to the individual needs of the patients.
No Intervention: Usual treatment
All patients follow conventional admission course which implies preoperative seminar and a discharge planning consultation on the day of discharge. The patients are discharged to home, referred to physiotherapy in the community and a scheduled follow-up by the surgeon after 3 month in the orthopedic outpatient clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in physical function assessed by ≥ 12 points in physical function score in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Time Frame: 3 days, 1, 3, 6 and 12 months post-surgery
The WOMAC Index is disease specific measuring health status om three subscales: pain, stiffness and physical function
3 days, 1, 3, 6 and 12 months post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the pain and stiffness score in WOMAC Index
Time Frame: 3 days, 1, 3, 6 and 12 months post-surgery
3 days, 1, 3, 6 and 12 months post-surgery
Changes in all scores in the subscales in Medical Outcomes Study Short Form (SF-36)
Time Frame: 3 days, 1, 3, 6 and 12 months post-surgery
A generic measure of health related quality of life
3 days, 1, 3, 6 and 12 months post-surgery
Change in the score in the General Self-Efficacy Scale
Time Frame: 3 days, 1, 3 and 6 months post-surgery
An unidimensional measure of general self-efficacy.
3 days, 1, 3 and 6 months post-surgery
Number of acute visits to the orthopedic outpatient clinic
Time Frame: 3 days, 1, 3, 6 anf 12 months post-surgery
3 days, 1, 3, 6 anf 12 months post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

University Hospital, Gentofte, Copenhagen

Investigators

  • Principal Investigator: Kirsten Szöts, University Hospital Gentofte

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 15, 2013

First Posted (Estimate)

January 18, 2013

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNR-2013112-4
  • R108-A2423 (Other Grant/Funding Number: The Danish Rheumatism Association)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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