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

Knee Osteoarthritis Clinical Trial

Official title:

The Empowerment Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05940246
• Other study ID #: The Empowerment TKA Study
• Status: Recruiting
• Phase: N/A
• Start date: April 28, 2022
• Est. completion date: April 2025

Study information

• Verified date: June 2023
• Source: Region Stockholm
• Contact: Siri Heijbel, PhD student, MD
• Phone: 0046704241607
• Email: siri.heijbel[@]regionstockholm.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Scheduled for primary knee arthroplasty

Exclusion Criteria:

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Motivational Interviewing
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.

Locations

Country	Name	City	State
Sweden	Capio Ortopediska Huset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression	Assessed by the Patient Health Questionnaire-9 (PHQ-9)	Preoperatively, 6 months postoperatively and 12 months postoperatively
Other	Health related quality of life	Assessed by the Short Form Health Survey (SF-36)	Preoperatively, 6 months postoperatively and 12 months postoperatively
Other	Expectations on the rehabilitation	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	Preoperatively
Other	Expectations on the surgical result	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	Preoperatively
Other	Recordings of MI	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.	0 to 6 months postoperatively
Primary	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	Assessed 6 months postoperatively
Primary	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	Assessed 12 months postoperatively
Primary	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	Assessed 6 months postoperatively
Primary	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	Assessed 12 months postoperatively
Secondary	Knee awareness	Assessed by the Forgotten Joint Score-12 (FJS)	Preoperatively, 6 months postoperatively and 12 months postoperatively
Secondary	Self-reported pain and function	Assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)	Preoperatively, 6 months postoperatively and 12 months postoperatively
Secondary	Knee function	Assessed by the "5 times sit to stand"-test. Patients receive written instructions and perform the test themselves at home.	Preoperatively, 6 months postoperatively and 12 months postoperatively
Secondary	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	12 months postoperatively
Secondary	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	6 months postoperatively, 12 months postoperatively