NCT03375541

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2018

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

1 year

First QC Date

December 8, 2017

Last Update Submit

May 23, 2018

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time to new medication start

    6 months

  • Medication adherence

    At enrollment and at each subsequent visit for one year

  • Change from Baseline Disease Self-efficacy at 6 months

    At enrollment and at 6 months post-visit

  • Change from Baseline Disease Self-efficacy at 12 months

    At enrollment and at 12 months post-visit

Study Arms (2)

Control

NO INTERVENTION

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

Calculator

EXPERIMENTAL

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

Other: Risk Aversion Calculator

Interventions

Risk Aversion CalculatorOTHER

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)

Calculator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Fletcher Hartsell, MD MPH

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2017

First Posted

December 18, 2017

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

May 24, 2018

Record last verified: 2018-05