A Phase 4 interventional study of Educational handout and Verbal script in Osteoarthritis, Knee, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-05.
Sponsored by Hospital for Special Surgery, New York · Phase 4, Interventional, and Other
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.
4,398 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.
This study's enrollment of 24 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Hospital for Special Surgery, New York is the lead sponsor of 217 studies on the registry; 39 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 20 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: Educational handout · Drug: Hyaluronic Acid
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).
Other: Educational handout · Other: Verbal script · Drug: Hyaluronic Acid
The educational handout will include information on self-management strategies.
The verbal script will include details on self-management strategies that will be reviewed with the patient.
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.
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
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
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
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
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
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
| Milestone | Teaching Method A | Teaching Method B |
|---|---|---|
| Started | 12 | 12 |
| Completed | 12 | 12 |
| Not completed | 0 | 0 |
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.
| units on a scale | Teaching Method A | Teaching Method B |
|---|---|---|
| Patient Satisfaction With the Teaching Method | 8.8 ± 1.6 | 8.3 ± 2.2 |
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.
| units on a scale | Teaching Method A | Teaching Method B |
|---|---|---|
| Provider Satisfaction With the Teaching Method | 6.0 ± 1.9 | 8.0 ± 1.0 |
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.
| units on a scale | Teaching Method A | Teaching Method B |
|---|---|---|
| Patient Satisfaction With the Teaching Method | 8.6 ± 2.2 | 8.6 ± 1.0 |
Patient will be asked: "Would you have preferred a different method of receiving education?"
| Participants | Teaching Method A | Teaching Method B |
|---|---|---|
| Number of Patients Who Would Have Preferred a Different Method of Receiving Education. | 1 | 1 |
Patient will be asked: "Did the education you received help with the care of your osteoarthritis?"
| Participants | Teaching Method A | Teaching Method B |
|---|---|---|
| Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis | 7 | 8 |
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.
| score on a scale | Teaching Method A | Teaching Method B |
|---|---|---|
| PROMIS Physical Health Score | 45.8 ± 5.1 | 48.4 ± 6.5 |
Collected over Adverse event data were collected over 3 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Teaching Method A | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Teaching Method B | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Teaching Method A | Teaching Method B | Total |
|---|---|---|---|
| Mean | 71 ± 8 | 69 ± 13 | 70 ± 10 |
| Sex: Female, Male(Participants) | Teaching Method A | Teaching Method B | Total |
|---|---|---|---|
| Female | 8 | 10 | 18 |
| Male | 4 | 2 | 6 |
| Race (NIH/OMB)(Participants) | Teaching Method A | Teaching Method B | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 11 | 9 | 20 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Region of Enrollment(participants) | Teaching Method A | Teaching Method B | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
| Average pain(units on a 0-10 scale) | Teaching Method A | Teaching Method B | Total |
|---|---|---|---|
| Mean | 5.6 ± 2.2 | 4.8 ± 2.3 | 5.2 ± 2.2 |
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Hospital for Special Surgery, New York