- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05940246
Investigating the Role of Motivational Interviewing in Swedish Patients Undergoing Knee Arthroplasty
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Stockholm, Sweden
- Capio Ortopediska Huset
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Scheduled for primary knee arthroplasty
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Standard treatment
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Experimental: Motivational interviewing
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction with the rehabilitation
Time Frame: Assessed 6 months postoperatively
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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
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Assessed 6 months postoperatively
|
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Satisfaction with the rehabilitation
Time Frame: Assessed 12 months postoperatively
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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
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Assessed 12 months postoperatively
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Satisfaction with the knee
Time Frame: Assessed 6 months postoperatively
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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
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Assessed 6 months postoperatively
|
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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
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Assessed 12 months postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee awareness
Time Frame: Preoperatively, 6 months postoperatively and 12 months postoperatively
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Assessed by the Forgotten Joint Score-12 (FJS)
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Preoperatively, 6 months postoperatively and 12 months postoperatively
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Self-reported pain and function
Time Frame: Preoperatively, 6 months postoperatively and 12 months postoperatively
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Assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
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Preoperatively, 6 months postoperatively and 12 months postoperatively
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Knee function
Time Frame: Preoperatively, 6 months postoperatively and 12 months postoperatively
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Assessed by the "5 times sit to stand"-test.
Patients receive written instructions and perform the test themselves at home.
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Preoperatively, 6 months postoperatively and 12 months postoperatively
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Patient reported experience measures
Time Frame: 12 months postoperatively
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Three questions own patients own experiences
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12 months postoperatively
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Knee improvement
Time Frame: 6 months postoperatively, 12 months postoperatively
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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
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6 months postoperatively, 12 months postoperatively
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Depression
Time Frame: Preoperatively, 6 months postoperatively and 12 months postoperatively
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Assessed by the Patient Health Questionnaire-9 (PHQ-9)
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Preoperatively, 6 months postoperatively and 12 months postoperatively
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Health related quality of life
Time Frame: Preoperatively, 6 months postoperatively and 12 months postoperatively
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Assessed by the Short Form Health Survey (SF-36)
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Preoperatively, 6 months postoperatively and 12 months postoperatively
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Expectations on the rehabilitation
Time Frame: Preoperatively
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Patient reported outcome.
Question: "How would you define your expectations on the rehabilitation?"
Answer options: (1) Very high, (2) High, (3) Neither, (4) Low and (5) Very low
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Preoperatively
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Expectations on the surgical result
Time Frame: Preoperatively
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Patient reported outcome.
Question: "How would you define your expectations on the final surgical result?"
Answer options: (1) Very high, (2) High, (3) Neither, (4) Low and (5) Very low
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Preoperatively
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Recordings of MI
Time Frame: 0 to 6 months postoperatively
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All 6 postoperative MI-calls on all patients in the intervention group is recorded and will be analysed by a group (MIQA-gruppen) that specialises in coding MI-calls.
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0 to 6 months postoperatively
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Margareta Hedström, Professor, MD, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Rheumatic Diseases
- Osteoarthritis
- Behavior
- Treatment Adherence and Compliance
- Health Behavior
- Patient Acceptance of Health Care
- Osteoarthritis, Knee
- Patient Participation
- Health Services
- Health Care Facilities Workforce and Services
- Behavioral Disciplines and Activities
- Directive Counseling
- Counseling
- Mental Health Services
- Motivational Interviewing
Other Study ID Numbers
- The Empowerment TKA Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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