Osteoarthritis, Knee
Conditions
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.
Interventions
OTHEREducational handout
The educational handout will include information on self-management strategies.
OTHERVerbal script
The verbal script will include details on self-management strategies that will be reviewed with the patient.
DRUGHyaluronic Acid
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.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction With the Teaching Method | 1 month post-injection | 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 | 1 month post-injection | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Who Would Have Preferred a Different Method of Receiving Education. | 3 months post-injection | 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 | 3 months post-injection | Patient will be asked: Did the education you received help with the care of your osteoarthritis? |
| PROMIS Physical Health Score | 3 months post-injection | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Teaching Method A 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.
Educational handout: The educational handout will include information on self-management strategies.
Hyaluronic Acid: 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. | 12 |
| Teaching Method B 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).
Educational handout: The educational handout will include information on self-management strategies.
Verbal script: The verbal script will include details on self-management strategies that will be reviewed with the patient.
Hyaluronic Acid: 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. | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Teaching Method A | Teaching Method B | Total |
|---|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 8 | 69 years STANDARD_DEVIATION 13 | 70 years STANDARD_DEVIATION 10 |
| Average pain | 5.6 units on a 0-10 scale STANDARD_DEVIATION 2.2 | 4.8 units on a 0-10 scale STANDARD_DEVIATION 2.3 | 5.2 units on a 0-10 scale STANDARD_DEVIATION 2.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 11 Participants | 9 Participants | 20 Participants |
| Region of Enrollment United States | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
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.
Time frame: 1 month post-injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teaching Method A | Patient Satisfaction With the Teaching Method | 8.8 units on a scale | Standard Deviation 1.6 |
| Teaching Method B | Patient Satisfaction With the Teaching Method | 8.3 units on a scale | Standard Deviation 2.2 |
Primary
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.
Time frame: 3 months post-injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teaching Method A | Patient Satisfaction With the Teaching Method | 8.6 units on a scale | Standard Deviation 2.2 |
| Teaching Method B | Patient Satisfaction With the Teaching Method | 8.6 units on a scale | Standard Deviation 1 |
Primary
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.
Time frame: 1 month post-injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teaching Method A | Provider Satisfaction With the Teaching Method | 6.0 units on a scale | Standard Deviation 1.9 |
| Teaching Method B | Provider Satisfaction With the Teaching Method | 8.0 units on a scale | Standard Deviation 1 |
Secondary
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?
Time frame: 3 months post-injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Teaching Method A | Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis | 7 Participants |
| Teaching Method B | Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis | 8 Participants |
Secondary
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?
Time frame: 3 months post-injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Teaching Method A | Number of Patients Who Would Have Preferred a Different Method of Receiving Education. | 1 Participants |
| Teaching Method B | Number of Patients Who Would Have Preferred a Different Method of Receiving Education. | 1 Participants |
Secondary
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.
Time frame: 3 months post-injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Teaching Method A | PROMIS Physical Health Score | 45.8 score on a scale | Standard Deviation 5.1 |
| Teaching Method B | PROMIS Physical Health Score | 48.4 score on a scale | Standard Deviation 6.5 |