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
  Purpose

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.


Condition Intervention
Osteoarthritis
Behavioral: Telephone follow-up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Nurse Led Follow-up After Total Knee Arthroplasty - a Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 116
Study Start Date: January 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01771315

Locations
Denmark
University Hospital Gentofte
Hellerup, Gentofte, Denmark, 2900
Sponsors and Collaborators
University of Southern Denmark
University Hospital, Gentofte, Copenhagen
Investigators
Principal Investigator: Kirsten Szöts University Hospital Gentofte
  More Information

No publications provided

Responsible Party: Birte Oestergaard, Associate professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01771315     History of Changes
Other Study ID Numbers: UNR-2013112-4, R108-A2423
Study First Received: January 15, 2013
Last Updated: January 6, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
total knee arthroplasty
telephone follow-up
physical function
health related quality of life
self-efficacy

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 14, 2014