Drug Risk Aversion Calculator Use to Facilitate MS Patient Self-efficacy

Multiple Sclerosis Clinical Trial

— DRAC  

Official title:

Benefits of Drug Risk Aversion Calculation to Multiple Sclerosis Drug Choice and Patient Self-efficacy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03375541
• Other study ID #: Pro00081429
• Status: Withdrawn
• Phase: N/A
• Start date: March 2018
• Est. completion date: March 2019

Study information

• Verified date: May 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators seek to determine if the use of a Side Effect Aversion Calculator helps patients with multiple sclerosis (MS) more comfortably and rapidly identify the disease modifying drug (DMD) that is best suited for the patient.

Description:

Settling into the use of a multiple sclerosis disease modifying drug (DMD) can seem like taking an important final examination, consisting of a single multiple choice question with 16 equally appropriate responses, having months or even years to second-guess your choice, and then getting a grade but never being told the correct answer.

Making the choice between these options can be overwhelming, leaving patients feeling both disempowered and depersonalized in the decision-making process.

In order to allow a better, more personalized, decision-making process the investigators introduce a side effect aversion calculator, which takes a patient's individual side effect aversion profile into consideration when discussing the start of a new disease modifier (initial drug, or drug switch). Subjects will be multiple sclerosis patients who have a provider-identified need for DMD initiation or DMD switch and receive their care at Duke. Recruitment goal is 100 subjects. Those randomized to "calculator arms" will be reminded that the purpose of the calculator is to facilitate the DMD choice discussion, NOT make the decision. Subjects asked to rate level of concern over adverse events (AEs) across all DMDs. Calculator multiplies subject response by the prevalence reported within DMD prescribing information. Sum of these weighted scores reveals a DMD's Total Aversion score and medication ranking by patient's specific side effect aversion profile, therefore framing discussion. Enrollment visit concludes with survey designed to collect MS clinical history, MS symptoms, medication history, medication adherence and self-efficacy. This same survey is conducted prior to subsequent three clinic visits.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be at least 18 years old

• Be able to read and speak English

• Be currently treated or starting treatment with an MS disease modifying medication

Exclusion Criteria:

• All of the inclusion criteria must be met. If they cannot be met, then they are excluded from the study

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Risk Aversion Calculator
The calculator asks the participant to rate their level of aversion to having a set list of potential medication side effects (0 = no concern; 1 = mild concern; 2 = moderate concern; 3 = moderate to severe concern; 4 = severe concern)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Disease Self-efficacy	Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis	Baseline and then at the conclusion of the initial 1 day visit
Secondary	Time to new medication start	The amount of time (in days) from initial treatment discussion to treatment start	6 months
Secondary	Medication adherence	The percentage of all prescribed doses of a medication that a patient takes	At enrollment and at each subsequent visit for one year
Secondary	Change from Baseline Disease Self-efficacy at 6 months	Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis	At enrollment and at 6 months post-visit
Secondary	Change from Baseline Disease Self-efficacy at 12 months	Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis	At enrollment and at 12 months post-visit