Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Educational handout
Verbal script
Hyaluronic Acid
Sponsored by
About this trial
This is an interventional other trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Patients of co-investigator physicians
- Age 18+ years
- Diagnosis of symptomatic knee osteoarthritis
- Scheduled for a hyaluronic acid injection into the knee
- Provider is available to administer teaching method
Exclusion Criteria:
- Patients who are already enrolled in the study
- Non-English speaking
Sites / Locations
- Hospital for Special Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Teaching Method A
Teaching Method B
Arm Description
Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.
Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).
Outcomes
Primary Outcome Measures
Patient Satisfaction With the Teaching Method
Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
Provider Satisfaction With the Teaching Method
Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
Patient Satisfaction With the Teaching Method
Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
Secondary Outcome Measures
Number of Patients Who Would Have Preferred a Different Method of Receiving Education.
Patient will be asked: "Would you have preferred a different method of receiving education?"
Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis
Patient will be asked: "Did the education you received help with the care of your osteoarthritis?"
PROMIS Physical Health Score
The physical health score will be surveyed using the PROMIS-10 global health questionnaire. A higher score indicates better physical health. Scores range from 16.2 to 67.7.
Full Information
NCT ID
NCT03245463
First Posted
August 7, 2017
Last Updated
October 16, 2019
Sponsor
Hospital for Special Surgery, New York
1. Study Identification
Unique Protocol Identification Number
NCT03245463
Brief Title
Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis
Official Title
Evaluation of Different Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
February 13, 2018 (Actual)
Study Completion Date
February 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Symptomatic knee osteoarthritis greatly impacts the quality of life, mobility, independence, and even safety of the individuals who suffer from it. One of the most powerful tools for these patients can be education on self-care and self-management strategies that can be taught to a patient by a physician, physical or occupational therapist, or a nurse. These self-management strategies can help patients treat daily stiffness through exercise or manage flares of osteoarthritis. There is a lack of consensus on the best teaching methods to accomplish the goal of educating our patients. Feedback from both patients and providers regarding teaching methods is needed. This study will evaluate teaching methods on self-management strategies for patients who are undergoing hyaluronic acid injections for knee osteoarthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teaching Method A
Arm Type
Active Comparator
Arm Description
Patient will receive an educational handout on self-management strategies. Patient will be asked to take the handout home to read and to call the office if he/she has any questions.
Arm Title
Teaching Method B
Arm Type
Active Comparator
Arm Description
Patient will receive an educational handout on self-management strategies. A provider will review the handout with the patient (approximately 5 minutes including a question-and-answer session).
Intervention Type
Other
Intervention Name(s)
Educational handout
Intervention Description
The educational handout will include information on self-management strategies.
Intervention Type
Other
Intervention Name(s)
Verbal script
Intervention Description
The verbal script will include details on self-management strategies that will be reviewed with the patient.
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Intervention Description
All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.
Primary Outcome Measure Information:
Title
Patient Satisfaction With the Teaching Method
Description
Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
Time Frame
1 month post-injection
Title
Provider Satisfaction With the Teaching Method
Description
Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
Time Frame
1 month post-injection
Title
Patient Satisfaction With the Teaching Method
Description
Satisfaction will be assessed using a 0-10 scale, where 0=not satisfied and 10=most satisfied. The higher the score, the greater the satisfaction.
Time Frame
3 months post-injection
Secondary Outcome Measure Information:
Title
Number of Patients Who Would Have Preferred a Different Method of Receiving Education.
Description
Patient will be asked: "Would you have preferred a different method of receiving education?"
Time Frame
3 months post-injection
Title
Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis
Description
Patient will be asked: "Did the education you received help with the care of your osteoarthritis?"
Time Frame
3 months post-injection
Title
PROMIS Physical Health Score
Description
The physical health score will be surveyed using the PROMIS-10 global health questionnaire. A higher score indicates better physical health. Scores range from 16.2 to 67.7.
Time Frame
3 months post-injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients of co-investigator physicians
Age 18+ years
Diagnosis of symptomatic knee osteoarthritis
Scheduled for a hyaluronic acid injection into the knee
Provider is available to administer teaching method
Exclusion Criteria:
Patients who are already enrolled in the study
Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Wyss, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis
We'll reach out to this number within 24 hrs