OsteoarthritisNFTKANCT01771315
Nurse Led Follow-up After Total Knee Arthroplasty
A study testing Telephone follow-up in people with Osteoarthritis, run by University of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Telephone follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2013to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- in terminal phase of another serious illness such as i.e. cancer with expected lifetime less than 6 months
- previous total hip replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse Led Follow-up After Total Knee Arthroplasty - a Randomized Trial
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Telephone follow-up
- Keywords
- total knee arthroplasty, telephone follow-up, physical function, health related quality of life, self-efficacy
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone follow-upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days, 1, 3, 6 and 12 months post-surgery
Secondary outcomes (4)
Change in the pain and stiffness score in WOMAC Index
Measured: 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)
A generic measure of health related quality of life
Measured: 3 days, 1, 3, 6 and 12 months post-surgery
Change in the score in the General Self-Efficacy Scale
An unidimensional measure of general self-efficacy.
Measured: 3 days, 1, 3 and 6 months post-surgery
Number of acute visits to the orthopedic outpatient clinic
Measured: 3 days, 1, 3, 6 anf 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Responsible party
- Principal investigator, Birte Oestergaard, University of Southern Denmark
- Investigators
- Kirsten Szöts, Principal investigator, University Hospital Gentofte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771315
- Sponsor's protocol ID
- UNR-2013112-4
- Other IDs
- R108-A2423
- Acronym
- NFTKA
- Status last verified
- Jun 2015
- First submitted
- 15 Jan 2013
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24872728
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Led Follow-up After Total Knee Arthroplasty - a Randomized Trial
- ClinicalTrials.gov ID
- NCT01771315
- Acronym / sponsor ID
- NFTKA / UNR-2013112-4
- Conditions
- Osteoarthritis
- Keywords
- total knee arthroplasty, telephone follow-up, physical function, health related quality of life, self-efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 18 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telephone follow-up | Experimental | Behavioral: Telephone follow-upNurse led follow-up in form of consultation by telephone 4 days and 2weeks after discharge, respectively as a supplement to conventional admission course. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- in terminal phase of another serious illness such as i.e. cancer with expected lifetime less than 6 months
- previous total hip replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone follow-upThe 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. | Behavioural | telephone follow-up |
Primary outcome
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
The WOMAC Index is disease specific measuring health status om three subscales: pain, stiffness and physical function
4 secondary outcomes
Change in the pain and stiffness score in WOMAC Index
Time frame: 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)
Time frame: 3 days, 1, 3, 6 and 12 months post-surgery
Change in the score in the General Self-Efficacy Scale
Time frame: 3 days, 1, 3 and 6 months post-surgery
Number of acute visits to the orthopedic outpatient clinic
Time frame: 3 days, 1, 3, 6 anf 12 months post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Derived from this study: PubMed 24872728Szots 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Szöts principal investigator
University Hospital Gentofte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone follow-up in people with Osteoarthritis, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01771315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.