NCT05940246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 28, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

April 14, 2026

Status Verified

November 1, 2024

Enrollment Period

3.4 years

First QC Date

June 20, 2023

Last Update Submit

April 13, 2026

Conditions

Keywords

Knee arthroplastyPatient empowermentMotivational interviewing

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (5)

  • Knee awareness

    Preoperatively, 6 months postoperatively and 12 months postoperatively

  • Self-reported pain and function

    Preoperatively, 6 months postoperatively and 12 months postoperatively

  • Knee function

    Preoperatively, 6 months postoperatively and 12 months postoperatively

  • Patient reported experience measures

    12 months postoperatively

  • Knee improvement

    6 months postoperatively, 12 months postoperatively

Other Outcomes (5)

  • Depression

    Preoperatively, 6 months postoperatively and 12 months postoperatively

  • Health related quality of life

    Preoperatively, 6 months postoperatively and 12 months postoperatively

  • Expectations on the rehabilitation

    Preoperatively

  • +2 more other outcomes

Study Arms (2)

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.

Behavioral: Motivational Interviewing

Standard treatment

NO INTERVENTION

Standard treatment

Interventions

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.

Motivational interviewing

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for primary knee arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capio Ortopediska Huset

Stockholm, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, KneePatient Participation

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Margareta Hedström, Professor, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2023

First Posted

July 11, 2023

Study Start

April 28, 2022

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

April 14, 2026

Record last verified: 2024-11

Locations