Nurse Led Follow-up After Total Knee Arthroplasty

Osteoarthritis Clinical Trial

— NFTKA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771315
• Other study ID #: UNR-2013112-4
• Secondary ID: R108-A2423
• Status: Completed
• Phase: N/A
• First received: January 15, 2013
• Last updated: June 2, 2015
• Start date: January 2013
• Est. completion date: November 2014

Study information

• Verified date: June 2015
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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.

Locations

Country	Name	City	State
Denmark	University Hospital Gentofte	Hellerup	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 days, 1, 3, 6 and 12 months post-surgery	No
Secondary	Change in the pain and stiffness score in WOMAC Index		3 days, 1, 3, 6 and 12 months post-surgery	No
Secondary	Changes in all scores in the subscales in Medical Outcomes Study Short Form (SF-36)	A generic measure of health related quality of life	3 days, 1, 3, 6 and 12 months post-surgery	No
Secondary	Change in the score in the General Self-Efficacy Scale	An unidimensional measure of general self-efficacy.	3 days, 1, 3 and 6 months post-surgery	No
Secondary	Number of acute visits to the orthopedic outpatient clinic		3 days, 1, 3, 6 anf 12 months post-surgery	No