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

Primary Purpose

Multiple Sclerosis

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Risk Aversion Calculator
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Calculator

    Arm Description

    Natural discussion of disease modifier selection conducted without augmentation by risk aversion calculator

    Natural discussion of disease modifier selection conducted with augmentation by risk aversion calculator

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Time to new medication start
    The amount of time (in days) from initial treatment discussion to treatment start
    Medication adherence
    The percentage of all prescribed doses of a medication that a patient takes
    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
    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

    Full Information

    First Posted
    December 8, 2017
    Last Updated
    May 23, 2018
    Sponsor
    Duke University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03375541
    Brief Title
    Drug Risk Aversion Calculator Use to Facilitate MS Patient Self-efficacy
    Acronym
    DRAC
    Official Title
    Benefits of Drug Risk Aversion Calculation to Multiple Sclerosis Drug Choice and Patient Self-efficacy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Clinical workflow was too high
    Study Start Date
    March 2018 (Anticipated)
    Primary Completion Date
    March 2019 (Anticipated)
    Study Completion Date
    March 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Duke University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Multiple Sclerosis

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized control trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Natural discussion of disease modifier selection conducted without augmentation by risk aversion calculator
    Arm Title
    Calculator
    Arm Type
    Experimental
    Arm Description
    Natural discussion of disease modifier selection conducted with augmentation by risk aversion calculator
    Intervention Type
    Other
    Intervention Name(s)
    Risk Aversion Calculator
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Change from Baseline Disease Self-efficacy
    Description
    Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis
    Time Frame
    Baseline and then at the conclusion of the initial 1 day visit
    Secondary Outcome Measure Information:
    Title
    Time to new medication start
    Description
    The amount of time (in days) from initial treatment discussion to treatment start
    Time Frame
    6 months
    Title
    Medication adherence
    Description
    The percentage of all prescribed doses of a medication that a patient takes
    Time Frame
    At enrollment and at each subsequent visit for one year
    Title
    Change from Baseline Disease Self-efficacy at 6 months
    Description
    Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis
    Time Frame
    At enrollment and at 6 months post-visit
    Title
    Change from Baseline Disease Self-efficacy at 12 months
    Description
    Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis
    Time Frame
    At enrollment and at 12 months post-visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Fletcher Hartsell, MD MPH
    Organizational Affiliation
    Duke University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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