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

NCT03245463 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2017-0731
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Number of Patients Who Would 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

  3 months post-injection

• PROMIS Physical Health Score

  3 months post-injection

Study Arms (2)

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.

Other: Educational handout; Drug: Hyaluronic Acid

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).

Other: Educational handout; Other: Verbal script; Drug: Hyaluronic Acid

Interventions

Educational handout OTHER

The educational handout will include information on self-management strategies.

Teaching Method A; Teaching Method B

Verbal script OTHER

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

Teaching Method B

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.

Teaching Method A; Teaching Method B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who are already enrolled in the study
• Non-English speaking

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. James Wyss
• Organization: Hospital for Special Surgery

wyssj@hss.edu

2126061731

Study Officials

• James Wyss, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 10, 2017
• Study Start: August 9, 2017
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: November 5, 2019
• Results First Posted: November 5, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)