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NCT03245463

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

Completed Phase 4 Results posted Last updated 5 November 2019
What this trial tests

Phase 4 trial testing Educational handout in Osteoarthritis, Knee in 24 participants. Completed in 13 February 2018.

Timeline
9 August 2017
Primary endpoint
13 February 2018
13 February 2018

Quick facts

Lead sponsorHospital for Special Surgery, New York
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeother
Enrollment24
Start date9 August 2017
Primary completion13 February 2018
Estimated completion13 February 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Hospital for Special Surgery, New York

Who can join

18 and older, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Satisfaction With the Teaching Method Primary · 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.

GroupValue95% CI
Teaching Method A8.8± 1.6
Teaching Method B8.3± 2.2
Provider Satisfaction With the Teaching Method Primary · 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.

GroupValue95% CI
Teaching Method A6.0± 1.9
Teaching Method B8.0± 1.0
Patient Satisfaction With the Teaching Method Primary · 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.

GroupValue95% CI
Teaching Method A8.6± 2.2
Teaching Method B8.6± 1.0
Number of Patients Who Would Have Preferred a Different Method of Receiving Education. Secondary · 3 months post-injection

Patient will be asked: "Would you have preferred a different method of receiving education?"

GroupValue95% CI
Teaching Method A1
Teaching Method B1
Number of Patients Who Believed That the Education They Received Helped With the Care of Their Osteoarthritis Secondary · 3 months post-injection

Patient will be asked: "Did the education you received help with the care of your osteoarthritis?"

GroupValue95% CI
Teaching Method A7
Teaching Method B8
PROMIS Physical Health Score Secondary · 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.

GroupValue95% CI
Teaching Method A45.8± 5.1
Teaching Method B48.4± 6.5

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Educational handout

Trials testing the same drug.

Other recruiting trials for Osteoarthritis, Knee

Currently open trials in the same condition.

Other Hospital for Special Surgery, New York trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03245463.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing