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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teaching Method A | Active Comparator | 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. |
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| Teaching Method B | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational handout | Other | The educational handout will include information on self-management strategies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 3 months post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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?" | 3 months post-injection |
| Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Wyss, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month post-injection |
|
Adverse event data were collected over 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James Wyss | Hospital for Special Surgery | 2126061731 | wyssj@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2017 | Aug 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Verbal script | Other | The verbal script will include details on self-management strategies that will be reviewed with the patient. |
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| Hyaluronic Acid | Drug | 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 will be asked: "Did the education you received help with the care of your osteoarthritis?" |
| 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. | 3 months post-injection |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Average pain | Average pain was assessed using a 0-10 scale, where 0 represents no pain and 10 represents worst possible pain. Higher scores represent worse outcomes. | Mean | Standard Deviation | units on a 0-10 scale |
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| 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 1 month post-injection |
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|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 3 months post-injection |
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| 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?" | Posted | Count of Participants | Participants | 3 months post-injection |
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| 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?" | Posted | Count of Participants | Participants | 3 months post-injection |
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| 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months post-injection |
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|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D012216 |
| Rheumatic Diseases |