NCT01771315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

January 15, 2013

Last Update Submit

June 2, 2015

Conditions

Osteoarthritis

Keywords

total knee arthroplastytelephone follow-upphysical functionhealth related quality of lifeself-efficacy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • Change in the pain and stiffness score in WOMAC Index

    3 days, 1, 3, 6 and 12 months post-surgery

  • Changes in all scores in the subscales in Medical Outcomes Study Short Form (SF-36)

    3 days, 1, 3, 6 and 12 months post-surgery

  • Change in the score in the General Self-Efficacy Scale

    3 days, 1, 3 and 6 months post-surgery

  • Number of acute visits to the orthopedic outpatient clinic

    3 days, 1, 3, 6 anf 12 months post-surgery

Study Arms (2)

telephone follow-up

EXPERIMENTAL

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

Usual treatment

NO INTERVENTION

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.

Interventions

Telephone follow-upBEHAVIORAL

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.

telephone follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • in terminal phase of another serious illness such as i.e. cancer with expected lifetime less than 6 months
  • previous total hip replacement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Gentofte

Hellerup, Gentofte, 2900, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 24872728DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kirsten Szöts

    University Hospital Gentofte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

January 15, 2013

First Posted

January 18, 2013

Study Start

January 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

June 3, 2015

Record last verified: 2015-06

Locations

DK(1)