Osteoarthritis, Knee Clinical Trial
Official title:
The Effect of Positive Cueing in the Information Video for Patients Undergoing Total Knee Arthroplasty: a Feasibility Study for a Randomized Controlled Trial.
Verified date | January 2023 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To the knowledge of the investigators, the feasibility of an RCT assessing the use of positive cueing in an information video for patients undergoing primary TKA is currently unclear. The investigators conducted a feasibility study with the primary objective to assess the acceptability of the randomized controlled trial (RCT) procedure for participating patients. The secondary objective was to evaluate the rate of recruitment, the comprehensibility (do patients understand what is expected of them during the trial) and if there were any adjustments necessary to the design of the study. The outcome of the current feasibility study will be used to determine whether adjustments are required to the design of the RCT before we proceed.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 1, 2021 |
Est. primary completion date | November 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years or older - end-stage knee osteoarthritis for which participants were scheduled for a TKA - sufficient Dutch languages skills to understand the information video - able to fill out the questionnaires. Exclusion Criteria: - not receiving TKA for osteoarthritis of the knee - not sufficient Dutch languages skills to understand the information video - not able to fill out the questionnaires. |
Country | Name | City | State |
---|---|---|---|
Netherlands | LUMC | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Onze Lieve Vrouwe Gasthuis |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility outcome measure: acceptibility. | The primary feasibility outcome score was the acceptability to participate, assessed with a developed questionnaire.
The investigators conducted a questionnaire about the experience of the participants with a Likart scale 1 - 5, existing of 4 questions. A total score of 12 or higher was interpreted as acceptable since the patient seemed have a positive experience according to the questionnaire. As part of the primary outcome measure (acceptibility), we monitored the time it took a patient to participate in the study. The study should not take more than one hour to be acceptable. |
During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires. | |
Secondary | Feasibility outcome measure: rate of recruitment | We determined the rate of recruitment by dividing the number of patients included in this study by the number of patients waiting for total knee arthroplasty meeting all inclusion criteria who were scheduled to be seen on the preoperative outpatient clinic appointment. | The number of the patients on the waiting list for total knee arthroplasty and the included patients were assessed two weeks before surgery, during the outpatient clinic visit. | |
Secondary | Feasibility outcome measure: comprehensibility | Do patients understand what is expected of them during the trial. We analyzed comprehensibility for the patients with a developed questionnaire with a cut off point < 9 and by assessing the rate of completion of the questionnaires (number of questions completed). Specific items that were consistently missing from the questionnaires and were not filled out by the patients were noted. Also, patients received one question about whether they thought the information in the video was easy to understand, cut off point < 3. | During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires. | |
Secondary | Feasibility outcome measure:patients' feedback to the current protocol. | After finishing the questionnaire we asked two feedback questions regarding the protocol:
what patients thought of participating in the study, and whether they had suggestions to improve the study process. The feedback from the patients were transcribed and similar answers were categorized. |
During the preoperative outpatient clinic visit two weeks before surgery. Directly after watching the video's and completing questionnaires. |
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