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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03245463
Other study ID # 2017-0731
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 9, 2017
Est. completion date February 13, 2018

Study information

Verified date October 2019
Source Hospital for Special Surgery, New York
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 13, 2018
Est. primary completion date February 13, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Hospital for Special Surgery New York New York

Sponsors (1)

Lead Sponsor Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
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