A Study Comparing Shared Solutions® Plus MS Center Support Versus Shared Solutions® Alone

Study Overview
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Brief Summary
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To compare the effectiveness of a 90-day Copaxone® adherence enhancement program for a sample of MS patients who are at high risk of nonadherence and receive support from Shared Solutions® and their MS Center versus those who receive support only from Shared Solutions®.

Official Title
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An Open Label, Prospective Parallel Cohort Study Comparing A 90-day Copaxone® Adherence Enhancement Program Among Persons With Multiple Sclerosis Who Participate in Shared Solutions® Alone or in Partnership With Their MS Center

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Procedure: Shared Solutions® plus MS Center v. Shared Solutions®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, 18 years of age or older. Diagnosed with Relapsing Remitting Multiple Sclerosis (relapses accepted). Beginning or restarting therapy with Glatiramer Acetate (Copaxone®). Willing and able to complete all procedures and evaluations related to the study. Willing to provide informed consent. Exclusion Criteria: Taking any other immunomodulatory or immunosuppressant therapy in conjunction with Copaxone®. Has a significant medical illness other than MS that may interfere with the assessment of endpoints or the subject's participation in the trial for the full duration of the study. Any situation that the investigator or nurse (if not the investigator) feel may interfere with participation in the study. Pregnant or trying to become pregnant, or breast feeding during the study. Previously participated in this study or another clinical research study in the past 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Shared Solutions® | Procedure: Shared Solutions® plus MS Center v. Shared Solutions®<br>* Copaxone<br>|
| Experimental: 2<br>Shared Solutions® and MS Center/Office Practice Partnership | Procedure: Shared Solutions® plus MS Center v. Shared Solutions®<br>* Copaxone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate of Copaxone therapy by procedural intervention |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance of treatment, positive experience of treatment, levels of depression, proportion of time spent, self injection competency ratings, and the risk of non-adherence/non-compliance |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Copaxone®, Shared Solutions®