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Investigating the Role of Motivational Interviewing in Swedish Patients Undergoing Knee Arthroplasty

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Motivational Interviewing
Sponsored by
Region Stockholm
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee arthroplasty, Patient empowerment, Motivational interviewing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Scheduled for primary knee arthroplasty Exclusion Criteria:

Sites / Locations

  • Capio Ortopediska HusetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Motivational interviewing

Standard treatment

Arm Description

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.

Standard treatment

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Knee awareness
Assessed by the Forgotten Joint Score-12 (FJS)
Self-reported pain and function
Assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee function
Assessed by the "5 times sit to stand"-test. Patients receive written instructions and perform the test themselves at home.
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
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

Full Information

First Posted
June 20, 2023
Last Updated
June 30, 2023
Sponsor
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT05940246
Brief Title
Investigating the Role of Motivational Interviewing in Swedish Patients Undergoing Knee Arthroplasty
Official Title
The Empowerment Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee arthroplasty, Patient empowerment, Motivational interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Motivational interviewing
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment
Arm Type
No Intervention
Arm Description
Standard treatment
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Satisfaction with the rehabilitation
Description
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
Time Frame
Assessed 6 months postoperatively
Title
Satisfaction with the rehabilitation
Description
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
Time Frame
Assessed 12 months postoperatively
Title
Satisfaction with the knee
Description
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
Time Frame
Assessed 6 months postoperatively
Title
Satisfaction with the knee
Description
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
Time Frame
Assessed 12 months postoperatively
Secondary Outcome Measure Information:
Title
Knee awareness
Description
Assessed by the Forgotten Joint Score-12 (FJS)
Time Frame
Preoperatively, 6 months postoperatively and 12 months postoperatively
Title
Self-reported pain and function
Description
Assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
Preoperatively, 6 months postoperatively and 12 months postoperatively
Title
Knee function
Description
Assessed by the "5 times sit to stand"-test. Patients receive written instructions and perform the test themselves at home.
Time Frame
Preoperatively, 6 months postoperatively and 12 months postoperatively
Title
Patient reported experience measures
Description
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
Time Frame
12 months postoperatively
Title
Knee improvement
Description
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
Time Frame
6 months postoperatively, 12 months postoperatively
Other Pre-specified Outcome Measures:
Title
Depression
Description
Assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time Frame
Preoperatively, 6 months postoperatively and 12 months postoperatively
Title
Health related quality of life
Description
Assessed by the Short Form Health Survey (SF-36)
Time Frame
Preoperatively, 6 months postoperatively and 12 months postoperatively
Title
Expectations on the rehabilitation
Description
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
Time Frame
Preoperatively
Title
Expectations on the surgical result
Description
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
Time Frame
Preoperatively
Title
Recordings of MI
Description
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.
Time Frame
0 to 6 months postoperatively

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Scheduled for primary knee arthroplasty Exclusion Criteria:
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siri Heijbel, PhD student, MD
Phone
0046704241607
Email
siri.heijbel@regionstockholm.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margareta Hedström, Professor, MD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capio Ortopediska Huset
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Investigating the Role of Motivational Interviewing in Swedish Patients Undergoing Knee Arthroplasty

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