Multiple SclerosisDRACNCT03375541
Drug Risk Aversion Calculator Use to Facilitate MS Patient Self-efficacy
A study testing Risk Aversion Calculator in people with Multiple Sclerosis, run by Duke University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Risk Aversion Calculator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2018to Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- All of the inclusion criteria must be met. If they cannot be met, then they are excluded from the study
About this study
Official title: Benefits of Drug Risk Aversion Calculation to Multiple Sclerosis Drug Choice and Patient Self-efficacy
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Risk Aversion Calculator
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Risk Aversion Calculator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and then at the conclusion of the initial 1 day visit
Secondary outcomes (4)
Time to new medication start
The amount of time (in days) from initial treatment discussion to treatment start
Measured: 6 months
Medication adherence
The percentage of all prescribed doses of a medication that a patient takes
Measured: At enrollment and at each subsequent visit for one year
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
Measured: At enrollment and at 6 months post-visit
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
Measured: At enrollment and at 12 months post-visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study startMar 2018 (estimated)
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Why it stopped: Clinical workflow was too high
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fletcher Hartsell, MD MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375541
- Sponsor's protocol ID
- Pro00081429
- Acronym
- DRAC
- Status last verified
- May 2018
- First submitted
- 8 Dec 2017
- Last updated
- 24 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Drug Risk Aversion Calculation to Multiple Sclerosis Drug Choice and Patient Self-efficacy
- ClinicalTrials.gov ID
- NCT03375541
- Acronym / sponsor ID
- DRAC / Pro00081429
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Clinical workflow was too high
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Natural discussion of disease modifier selection conducted without augmentation by risk aversion calculator |
| Calculator | Experimental | Other: Risk Aversion CalculatorNatural discussion of disease modifier selection conducted with augmentation by risk aversion calculator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- All of the inclusion criteria must be met. If they cannot be met, then they are excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Risk Aversion CalculatorThe 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) | Other | Calculator |
Primary outcome
Change from Baseline Disease Self-efficacy
Time frame: Baseline and then at the conclusion of the initial 1 day visit
Degree of change over time in a person's judgement of how well one can execute courses of action required to manage multiple sclerosis
4 secondary outcomes
Time to new medication start
Time frame: 6 months
Medication adherence
Time frame: At enrollment and at each subsequent visit for one year
Change from Baseline Disease Self-efficacy at 6 months
Time frame: At enrollment and at 6 months post-visit
Change from Baseline Disease Self-efficacy at 12 months
Time frame: At enrollment and at 12 months post-visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fletcher Hartsell, MD MPH principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Risk Aversion Calculator in people with Multiple Sclerosis, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Disease Self-efficacy (time frame: Baseline and then at the conclusion of the initial 1 day visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2018.