Knee OsteoarthritisNCT05940246
Investigating the Role of Motivational Interviewing in Swedish Patients Undergoing Knee Arthroplasty
A study testing Motivational Interviewing in people with Knee Osteoarthritis, run by Region Stockholm at 1 site in Sweden.
Trial summary
Knee arthroplasty is a successful surgical treatment for end-stage osteoarthritis. Most patients are satisfied with the result, however, 10% of the patients have remained dissatisfied over the last decades despite the advantages of the surgical procedure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteSweden
- Study dates
- 28 Apr 2022to 1 Oct 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Scheduled for primary knee arthroplasty
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Empowerment Study
Knee arthroplasty is a successful surgical treatment for end-stage osteoarthritis. Most patients are satisfied with the result, however, 10% of the patients have remained dissatisfied over the last decades despite the advantages of the surgical procedure. Previous studies suggest that rehabilitation needs to be individualized and that some patients request additional support.
Patient empowerment is a patient-centered strategy to increase, amongst other, patient engagement, participation, and motivation. Patient empowerment can be defined as a "process that helps people gain control over their own lives and increases their capacity to act on issues that they themselves define as important". One way of increasing patient empowerment is through motivational interviewing. Motivational interviewing is an evidence-based approach in which patients are supported to identify behavior changes toward their own individual goals.
The aim of this study is to investigate if motivational interviewing could increase satisfaction in patients undergoing knee arthroplasty. Furthermore, we want to examine role MI in this patient group with interviews of both MI-practitioners and patients as well as detailed investigations about the MI sessions.
- Conditions
- Knee Osteoarthritis
- Being tested
- Motivational Interviewing
- Keywords
- Knee arthroplasty, Patient empowerment, Motivational interviewing
- Medical subject headings
- Osteoarthritis, Knee, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
MI was introduced by William Miller in 1983 as a strategy to promote behavioral changes that would make people drink less. It is well established that MI can be successfully applied to many areas across the medical disciplines. Although the aim of MI is behavioral changes toward a specific goal it is necessary to understand the essence of MI with the "four key interrelated elements of the spirits of MI". These are partnership, acceptance, compassion, and evocation. Together they form an equal and respectful collaboration between the MI practitioner and the patient wherein empathy and acknowledgment are important pillars. Moreover, an important message derived from the spirit of MI is the belief that patients in themselves have and know what is needed and get support from the MI practitioner to find it.
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviewing | Experimental | Motivational Interviewing over the phone 1 time before surgery and 6 times (3-5 weeks interval) the first 6 months after surgery. Patients can contact a physical therapist in the first 6 months after surgery for additional questions and extra support. Receives: Behavioral: Motivational Interviewing |
| Standard treatment | No intervention | Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the rehabilitation
Patient reported outcome. Question: "How would you define your level of satisfaction with the rehabilitation?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied
Measured: Assessed 6 months postoperatively
Satisfaction with the rehabilitation
Patient reported outcome. Question: "How would you define your level of satisfaction with the rehabilitation?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied
Measured: Assessed 12 months postoperatively
Satisfaction with the knee
Patient reported outcome. Question: "How would you define your level of satisfaction with your operated knee?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied
Measured: Assessed 6 months postoperatively
Satisfaction with the knee
Patient reported outcome. Question: "How would you define your level of satisfaction with your operated knee?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied
Measured: Assessed 12 months postoperatively
Secondary outcomes (5)
Knee awareness
Assessed by the Forgotten Joint Score-12 (FJS)
Measured: Preoperatively, 6 months postoperatively and 12 months postoperatively
Self-reported pain and function
Assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Measured: Preoperatively, 6 months postoperatively and 12 months postoperatively
Knee function
Assessed by the "5 times sit to stand"-test. Patients receive written instructions and perform the test themselves at home.
Measured: Preoperatively, 6 months postoperatively and 12 months postoperatively
Patient reported experience measures
Three questions own patients own experiences
- "Did you receive the support you expected after your knee surgery?" Answer options: (1) Yes, more support than expected, (2) Yes, as much support as expected, (3) No, less support than expected and (4) No, considerably less support than expected
- "Did you participate in and had influence over the rehabilitation as you expected?" Answer options: (1) Yes, to very high degree, (2) Yes, to a high degree, (3) No, less than expected and (4) No, more than I wished for
- "Were you treated with dignity and respect in the contacts concerning your knee surgery from after the surgery until today" Answer options: (1) Yes, to a very high degree, (2) Yes, to a high degree, (3) No, to a low degree and (4) No, not at all
Measured: 12 months postoperatively
Knee improvement
Patient reported outcome. "Has your knee improved from the surgery?" Answer options: (1) Yes, the knee improved a lot from the surgery, (2) Yes, the knee improved a little bit from the surgery, (3) The surgery made no difference on the knee, (4) No, the knee is a little worse after surgery and (5) No, the knee is a lot worse after surgery
Measured: 6 months postoperatively, 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start28 Apr 2022
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Region StockholmThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Margareta Hedström, Professor, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940246
- Sponsor's protocol ID
- The Empowerment TKA Study
- Status last verified
- Nov 2024
- First submitted
- 20 Jun 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Empowerment Study
- ClinicalTrials.gov ID
- NCT05940246
- Acronym / sponsor ID
- The Empowerment TKA Study
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee arthroplasty, Patient empowerment, Motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 11 Jul 2023 (actual)
- 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.
Knee arthroplasty is a successful surgical treatment for end-stage osteoarthritis. Most patients are satisfied with the result, however, 10% of the patients have remained dissatisfied over the last decades despite the advantages of the surgical procedure. Previous studies suggest that rehabilitation needs to be individualized and that some patients request additional support.
Patient empowerment is a patient-centered strategy to increase, amongst other, patient engagement, participation, and motivation. Patient empowerment can be defined as a "process that helps people gain control over their own lives and increases their capacity to act on issues that they themselves define as important". One way of increasing patient empowerment is through motivational interviewing. Motivational interviewing is an evidence-based approach in which patients are supported to identify behavior changes toward their own individual goals.
The aim of this study is to investigate if motivational interviewing could increase satisfaction in patients undergoing knee arthroplasty. Furthermore, we want to examine role MI in this patient group with interviews of both MI-practitioners and patients as well as detailed investigations about the MI sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational interviewing | Experimental | Behavioral: Motivational InterviewingMotivational Interviewing over the phone 1 time before surgery and 6 times (3-5 weeks interval) the first 6 months after surgery. Patients can contact a physical therapist in the first 6 months after surgery for additional questions and extra support. |
| Standard treatment | No intervention | –Standard treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for primary knee arthroplasty
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Motivational InterviewingMI was introduced by William Miller in 1983 as a strategy to promote behavioral changes that would make people drink less. It is well established that MI can be successfully applied to many areas across the medical disciplines. Although the aim of MI is behavioral changes toward a specific goal it is necessary to understand the essence of MI with the "four key interrelated elements of the spirits of MI". These are partnership, acceptance, compassion, and evocation. Together they form an equal and respectful collaboration between the MI practitioner and the patient wherein empathy and acknowledgment are important pillars. Moreover, an important message derived from the spirit of MI is the belief that patients in themselves have and know what is needed and get support from the MI practitioner to find it. | Behavioural | Motivational interviewing |
Primary outcome
Satisfaction with the rehabilitation
Time frame: Assessed 6 months postoperatively
Patient reported outcome. Question: "How would you define your level of satisfaction with the rehabilitation?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied
Satisfaction with the rehabilitation
Time frame: Assessed 12 months postoperatively
Patient reported outcome. Question: "How would you define your level of satisfaction with the rehabilitation?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied
Satisfaction with the knee
Time frame: Assessed 6 months postoperatively
Patient reported outcome. Question: "How would you define your level of satisfaction with your operated knee?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied
Satisfaction with the knee
Time frame: Assessed 12 months postoperatively
Patient reported outcome. Question: "How would you define your level of satisfaction with your operated knee?" Answer options: (1) Very satisfied, (2) Satisfied, (3) Neither, (4) Dissatisfied and (5) Very dissatisfied
5 secondary outcomes
Knee awareness
Time frame: Preoperatively, 6 months postoperatively and 12 months postoperatively
Self-reported pain and function
Time frame: Preoperatively, 6 months postoperatively and 12 months postoperatively
Knee function
Time frame: Preoperatively, 6 months postoperatively and 12 months postoperatively
Patient reported experience measures
Time frame: 12 months postoperatively
Knee improvement
Time frame: 6 months postoperatively, 12 months postoperatively
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 14 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Margareta Hedström, Professor, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing in people with Knee Osteoarthritis, run by Region Stockholm at 1 site in Sweden.
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 1 inclusion and 0 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 14 Apr 2026. 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 Sweden. 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?
Satisfaction with the rehabilitation (time frame: Assessed 6 months postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.