Suspended

Shared Decision Making and How it Impacts Patient Understanding: Using an Interactive Knee Osteoarthritis App Based on a Cost Model to Generate a Patient Shared Decision Making Tool: Multi-center Randomized Clinical Trial Study Protocol

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What is being tested

Shared Decision Making Tool

Other
Who is being recruted

Arthritis+3

+ Joint Diseases

+ Musculoskeletal Diseases

From 45 to 64 Years
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: June 2016
See protocol details

Summary

Principal SponsorHospital for Special Surgery, New York
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2016

Actual date on which the first participant was enrolled.

Shared Decision Making (SDM) supports patient centered care and improves patient outcomes and satisfaction. Movement is Life (MIL) created an innovative SDM tool to provide a personalized framework for discussion of the projected impact to patients of their decisions regarding treatment options for knee osteoarthritis. 1. Did use of the MIL SDM tool for knee osteoarthritis result in an increased level of self-reported physical activity at one month in African American and Hispanic women? 2. Did use of the MIL SMD tool increase subject likeliness to recommend the physician? 3. What is the qualitative feedback from subjects on ease of use of the MIL SDM tool?

Official TitleShared Decision Making and How it Impacts Patient Understanding: Using an Interactive Knee Osteoarthritis App Based on a Cost Model to Generate a Patient Shared Decision Making Tool: Multi-center Randomized Clinical Trial Study Protocol
NCT04011488
Principal SponsorHospital for Special Surgery, New York
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

108 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 45 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Knee

Criteria

Inclusion Criteria: * \- Aged 45 to 64 years * Mild to moderate knee pain consistent with a diagnosis of osteoarthritis by the clinician * Self-identified as African American and/or Hispanic * At least one of the following comorbidities: 1. Obesity (BMI ≥ 30), 2. Hypertension (ICD10 codes below) 3. Diabetes (ICD10 codes below) Exclusion Criteria: * \- Known inflammatory arthritis (Lupus, Sjogrens, rheumatoid arthritis) * Prior total knee replacement * Recommended total knee replacement * Acute knee trauma

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
A simple, one-page tool that provides a framework for the patient discussion, which improves the consistency of the patient-provider communication. This SDM can also be customized to a specific patient based on gender, race/ethnicity, age, and select comorbidities (obesity, hypertension and diabetes).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Michael L. Parks, MD

New York, United StatesOpen Michael L. Parks, MD in Google Maps
SuspendedOne Study Center
Shared Decision Making and How it Impacts Patient Understanding: Using an Interactive Knee Osteoarthritis App Based on a Cost Model to Generate a Patient Shared Decision Making Tool: Multi-center Randomized Clinical Trial Study Protocol | PatLynk