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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Educational handout; Drug: Hyaluronic Acid; Other: Verbal script

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2017
• Primary Completion (Actual): February 13, 2018
• Study Completion (Actual): February 13, 2018

Study Registration Dates

• First Submitted: August 7, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 10, 2017

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: October 16, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 2017-0731

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No