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

• 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: Hospital for Special Surgery, New York
• Information provided by (Responsible Party): Hospital for Special Surgery, New York

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Principal Investigator: James Wyss, MD; Hospital for Special Surgery, New York

  Study Documents (Full-Text)

Documents provided by Hospital for Special Surgery, New York:

Study Protocol and Statistical Analysis Plan  [PDF] July 25, 2017

More Information

• Responsible Party: Hospital for Special Surgery, New York
• ClinicalTrials.gov Identifier: NCT03245463
• Other Study ID Numbers: 2017-0731
• First Posted: August 10, 2017
• 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

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Hyaluronic Acid; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Viscosupplements; Protective Agents