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Evaluation of Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03245463
Recruitment Status : Completed
First Posted : August 10, 2017
Results First Posted : November 5, 2019
Last Update Posted : November 5, 2019
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Other: Educational handout Other: Verbal script Drug: Hyaluronic Acid Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluation of Different Methods of Teaching Self-management Strategies to Patients With Symptomatic Knee Osteoarthritis
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : February 13, 2018
Actual Study Completion Date : February 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: 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.
Other: Educational handout
The educational handout will include information on self-management strategies.

Drug: 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.

Active Comparator: 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).
Other: Educational handout
The educational handout will include information on self-management strategies.

Other: Verbal script
The verbal script will include details on self-management strategies that will be reviewed with the patient.

Drug: 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 Outcome Measures :
  1. Patient Satisfaction With the Teaching Method [ Time Frame: 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.

  2. Provider Satisfaction With the Teaching Method [ Time Frame: 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.

  3. Patient Satisfaction With the Teaching Method [ Time Frame: 3 months 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 Outcome Measures :
  1. Number of Patients Who Would Have Preferred a Different Method of Receiving Education. [ Time Frame: 3 months post-injection ]
    Patient will be asked: "Would you have preferred a different method of receiving education?"

  2. Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis [ Time Frame: 3 months post-injection ]
    Patient will be asked: "Did the education you received help with the care of your osteoarthritis?"

  3. PROMIS Physical Health Score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245463


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: James Wyss, MD Hospital for Special Surgery, New York
  Study Documents (Full-Text)

Documents provided by Hospital for Special Surgery, New York:
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT03245463    
Other Study ID Numbers: 2017-0731
First Posted: August 10, 2017    Key Record Dates
Results First Posted: November 5, 2019
Last Update Posted: November 5, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents