NCT01905527

Adherence Trial With MS LifeLines ® Services

A Prospective, Parallel Group, Phase IV Study of Three Levels of MS LifeLines ® Support Services Provided to Patients Prescribed Rebif ® for Newly Diagnosed or First-switch Relapsing Remitting Multiple Sclerosis (RRMS)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 306 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase IV study to compare the current level of MS LifeLines ® (MSLL) services (face-to-face nursing visits and phone contacts) with customized MSLL services, to determine the optimal services to enhance medication adherence and treatment persistence with Rebif ® subcutaneous three times a week.

Detailed description

The proposed study is a web-based, prospective, parallel group, Phase IV, 12-month study of patients receiving support services provided by MSLL and contracted nursing services. Following referral of patients to MSLL, consenting patients will be allocated to one of two groups (2:1), based on their geographic area. Group A will be further randomized 1:1 to the standard services subgroup (Group A1) or a customized services subgroup (Group A2). The standard subgroup will receive phones calls and nurse visits at set intervals. Patients in the custom services subgroup will have the option of selecting as many or as few of the "standard" services they will receive after the initial injection training. Subjects will have the option of receiving educational materials, planning tools, and reminders. Patients allocated to Group B will receive a visit for injection training and the follow-up call and then MSLL phone calls at set intervals. Over a period of 12 months (each month defined as a 28-day period), all subjects will receive support services (nurse visit and follow-up phone call, etc) and complete online assessments (MSRS-R, PDSS, etc). The primary objective of the trial is to determine the impact of two different levels of support service, group A1 and A2, provided by MSLL within Group A, on adherence to prescribed treatment in newly diagnosed or first-switch relapsing remitting multiple sclerosis (RRMS) subjects. Secondary Objective: The secondary objectives are: * To use a pair wise comparison to determine the impact on adherence of the two different levels of service intervention provided by MSLL not compared in the primary objective (Standard services subgroup of Group A (A1) to Group B and Customized service subgroup of Group A (A2) to Group B) * To determine the correlation of adherence with subject-reported outcomes and other study data; * To examine the changes from baseline in subject-reported outcomes in each service arm; * To examine changes from baseline in risk for non-adherence in each service arm; and * To determine rate of trial dropout between each service arm

Conditions

• Multiple Sclerosis
• Relapsing-Remitting

Interventions

Type	Name	Description
OTHER	Standard Services of Group A (Group A1)	Support services provided in this group will include: Initial field nurse injection training visit; field nurse follow-up and subsequent visits; and follow-up phone calls at periodic intervals
OTHER	Customized Services of Group A (Group A2)	In addition to the initial field nurse injection training visit and follow-up call, subjects will select from support services including field nurse follow-up visits; follow-up phone calls; email and/or text reminders; subject self-assessment and use of treatment planning tools; and mail/e-mail educational materials.
OTHER	Group B	Support services provided in this group will include initial field nurse injection training visit and follow-up phone calls at periodic intervals.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2013-07-23
• Last updated: 2015-02-02

Locations

1 site across 1 country: United States