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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University Hospital, Gentofte, Copenhagen
Information provided by (Responsible Party):
Birte Oestergaard, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01771315
First received: January 15, 2013
Last updated: January 6, 2014
Last verified: January 2014

January 15, 2013
January 6, 2014
January 2013
February 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The WOMAC Index is disease specific measuring health status om three subscales: pain, stiffness and physical function
Same as current
Complete list of historical versions of study NCT01771315 on ClinicalTrials.gov Archive Site
  • Change in the pain and stiffness score in WOMAC Index [ Time Frame: 3 days, 1, 3, 6 and 12 months post-surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    A generic measure of health related quality of life
  • Change in the score in the General Self-Efficacy Scale [ Time Frame: 3 days, 1, 3 and 6 months post-surgery ] [ Designated as safety issue: No ]
    An unidimensional measure of general self-efficacy.
  • Number of acute visits to the orthopedic outpatient clinic [ Time Frame: 3 days, 1, 3, 6 anf 12 months post-surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nurse Led Follow-up After Total Knee Arthroplasty
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Osteoarthritis
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.
  • 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.
    Intervention: Behavioral: Telephone follow-up
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
116
February 2016
February 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01771315
UNR-2013112-4, R108-A2423
No
Birte Oestergaard, University of Southern Denmark
University of Southern Denmark
University Hospital, Gentofte, Copenhagen
Principal Investigator: Kirsten Szöts University Hospital Gentofte
University of Southern Denmark
January 2014

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