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

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Telephone follow-up
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring total knee arthroplasty, telephone follow-up, physical function, health related quality of life, self-efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Gentofte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

telephone follow-up

Usual treatment

Arm Description

Nurse led follow-up in form of consultation by telephone 4 days and 2weeks after discharge, respectively as a supplement to conventional admission course.

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.

Outcomes

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
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
Changes in all scores in the subscales in Medical Outcomes Study Short Form (SF-36)
A generic measure of health related quality of life
Change in the score in the General Self-Efficacy Scale
An unidimensional measure of general self-efficacy.
Number of acute visits to the orthopedic outpatient clinic

Full Information

First Posted
January 15, 2013
Last Updated
June 2, 2015
Sponsor
University of Southern Denmark
Collaborators
University Hospital, Gentofte, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01771315
Brief Title
Nurse Led Follow-up After Total Knee Arthroplasty
Acronym
NFTKA
Official Title
Nurse Led Follow-up After Total Knee Arthroplasty - a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
University Hospital, Gentofte, Copenhagen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
total knee arthroplasty, telephone follow-up, physical function, health related quality of life, self-efficacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
telephone follow-up
Arm Type
Experimental
Arm Description
Nurse led follow-up in form of consultation by telephone 4 days and 2weeks after discharge, respectively as a supplement to conventional admission course.
Arm Title
Usual treatment
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone follow-up
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in physical function assessed by ≥ 12 points in physical function score in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Description
The WOMAC Index is disease specific measuring health status om three subscales: pain, stiffness and physical function
Time Frame
3 days, 1, 3, 6 and 12 months post-surgery
Secondary Outcome Measure Information:
Title
Change in the pain and stiffness score in WOMAC Index
Time Frame
3 days, 1, 3, 6 and 12 months post-surgery
Title
Changes in all scores in the subscales in Medical Outcomes Study Short Form (SF-36)
Description
A generic measure of health related quality of life
Time Frame
3 days, 1, 3, 6 and 12 months post-surgery
Title
Change in the score in the General Self-Efficacy Scale
Description
An unidimensional measure of general self-efficacy.
Time Frame
3 days, 1, 3 and 6 months post-surgery
Title
Number of acute visits to the orthopedic outpatient clinic
Time Frame
3 days, 1, 3, 6 anf 12 months post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Szöts
Organizational Affiliation
University Hospital Gentofte
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Gentofte
City
Hellerup
State/Province
Gentofte
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
24872728
Citation
Szots K, Konradsen H, Solgaard S, Ostergaard B. Telephone follow-up by nurse following total knee arthroplasty - protocol for a randomized clinical trial (NCT 01771315). BMC Nurs. 2014 May 21;13:14. doi: 10.1186/1472-6955-13-14. eCollection 2014.
Results Reference
derived

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Nurse Led Follow-up After Total Knee Arthroplasty

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