Clinical trial NCT01771315: Nurse Led Follow-up After Total Knee Arthroplasty
Official title: Nurse Led Follow-up After Total Knee Arthroplasty - a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: total knee arthroplasty
telephone follow-up
physical function
health related quality of life
self-efficacy
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
First posted: 2013-01-18
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in physical function assessed by ≥ 12 points in physical function score in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
timeFrame: 3 days, 1, 3, 6 and 12 months post-surgery
Secondary outcomes:
measure: Change in the pain and stiffness score in WOMAC Index
timeFrame: 3 days, 1, 3, 6 and 12 months post-surgery
measure: Changes in all scores in the subscales in Medical Outcomes Study Short Form (SF-36)
timeFrame: 3 days, 1, 3, 6 and 12 months post-surgery
measure: Change in the score in the General Self-Efficacy Scale
timeFrame: 3 days, 1, 3 and 6 months post-surgery
measure: Number of acute visits to the orthopedic outpatient clinic
timeFrame: 3 days, 1, 3, 6 anf 12 months post-surgery
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: University Hospital Gentofte
state: Gentofte
Study officials:
affiliation: University Hospital Gentofte
name: Kirsten Szöts
role: PRINCIPAL_INVESTIGATOR
References:
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.