CLINICAL TRIAL

Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) for Aura

Recruiting · 18+ · All Sexes · Lebanon, NH

This study is evaluating whether a virtual cognitive self-management program can help individuals with multiple sclerosis.

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About the trial for Aura

Treatment Groups

This trial involves 2 different treatments. Home Based Self-management And Cognitive Training Changes Lives (HOBSCOTCH) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)
2015
N/A
~110

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 18+
No changes in antiepileptic and antidepressant medication regimen for 1 month, however brief discontinuation of antiepileptic medicine for inpatient video EEG evaluation is acceptable
Literate
Subjective memory complaints
Telephone access
Internet access
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Ongoing through entire study baseline - 12 months, and at baseline and at months 3, 6, 9, 12.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH) will improve 2 primary outcomes and 7 secondary outcomes in patients with Aura. Measurement will happen over the course of Ongoing through entire study baseline - 12 months.

Changes in self-reported seizure frequency
ONGOING THROUGH ENTIRE STUDY BASELINE - 12 MONTHS
The researchers will collect seizure information throughout the entire study by use of a smartphone app or paper log to track seizures daily. No range.
Changes in overall well-being
ONGOING THROUGH ENTIRE STUDY BASELINE - 12 MONTHS
The researchers will collect daily well-being information throughout the entire study by use of a smartphone app or paper log and a basic single item Likert-scale of well-being. No range.
Change in depression
BASELINE AND AT MONTHS 3, 6, 9, 12
The researchers will use the Patient Health Questionnaire (PHQ-9). The PHQ-9 is a brief 9-item validated depression scale. Scores range from 0 to 27. Scores of 5, 10, 15, and 20 represent cut-offs for mild, moderate, moderately severe, and severe depression, respectively.
Change in self-management practices
BASELINE AND AT MONTHS 3, 6, 9, 12
The researchers will use the Adult Epilepsy Self-Management Measurement Instrument (AESMMI-65).This is a 65 item scale that assesses use of epilepsy self-management practices. Scores range from 65 to 325, with a higher score indicating more frequent use of self-management strategies.
Changes in healthcare utilization
BASELINE AND AT MONTHS 3, 6, 9, 12
The researchers will use the Health Care Utilization 4-item measure from the Self-Management Resource Center to capture utilization of health services in the last 6 months. No range.
Change in quality of life
BASELINE AND AT MONTHS 3, 6, 9, 12
The researchers will use the Quality of Life in Epilepsy (QOLIE-31). This validated tool contains 16 multi-item scales which assess health related quality of life, emotional well-being, memory and attention deficits, medication effects, seizure control, psychosocial functioning, and health perception. Scores range from 0 to 100, with a higher score reflecting a higher quality of life.
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Who is running the study

Principal Investigator
B. J.
Barbara Jobst, Staff Physician, Neurology
Dartmouth-Hitchcock Medical Center

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get aura a year in the United States?

The most frequently reported symptoms of aura in patients with unipolar depression are visual symptoms and flushing. Patients with unipolar depression without aura seldom report aura and if they do, they do not meet DSM-IV or ICD-10 criteria for the diagnosis.

Anonymous Patient Answer

What is aura?

An aura, which can be defined as an atypical sensory, visual, or cognitive experience, is a transient phenomenon occurring in relation to a major neurological event, typically an aura preceding a transient ischemic attack. It is a common symptom of stroke.\n

Anonymous Patient Answer

What are the signs of aura?

The most common sensory symptom of aura is pressure or burning sensation in the back of the head, neck, and trunk, especially if the aura is localized. The other common physical symptom is facial numbness.

Anonymous Patient Answer

What causes aura?

The occurrence of aura is a relatively infrequent but non-uniform occurrence with a variable number of symptoms in each individual patient. The occurrence of aura is not related to a particular cause. The term aura is not appropriate as it is only partially informative.

Anonymous Patient Answer

Can aura be cured?

Although there is no cure for AVBs, the prognosis of patients with AVBs is not particularly poor. The optimal management of AVBs is not yet well defined in scientific literature. As far as the natural history of AVBs is concerned, the majority of patients are free from any complications or side effects or have good results for quality of life. These cases may be better managed than those with other types of AVBs, with less disruption to daily life, less time on hospitalisation, and less cost.

Anonymous Patient Answer

What are common treatments for aura?

There is little evidence to support one particular treatment, but research from recent years has been ongoing. The use of antiepileptic medication has been questioned, but there are preliminary data that show they may be useful. In contrast, some recent studies show that the use of antihypertensive medication before a seizure event may be useful. Trials of antiepileptic and antihypertensive drugs are ongoing.

Anonymous Patient Answer

How does home based self-management and cognitive training changes lives (hobscotch) work?

A self-management and cognitive training program can have substantial impact on individuals with heart failure and HF patients can be educated to manage CHF self-management and lifestyle behavior without a formal course.

Anonymous Patient Answer

What is the average age someone gets aura?

In the past, there was general agreement that typical age for the onset of aura might be at around 65 to 70. However, because of the large variability we were not able to conclude that aura is rarely observed in people younger than age 65. On the other hand, the findings also lend weak support to people aged 80 and 90 being more likely to suffer auras than those aged 65 and 70.

Anonymous Patient Answer

Does home based self-management and cognitive training changes lives (hobscotch) improve quality of life for those with aura?

The AHA intervention appeared to offer clinically and statistically significant improvements in quality of life. More sustained effects were expected through a further 10 week follow up.

Anonymous Patient Answer

Have there been any new discoveries for treating aura?

The aura of the migraine has been known to have many causes; however, they all have a similar result, as this proves to be a trigger for the migraine headaches. The causes of aura have been linked to the activation of some areas of the brain like the temporal lobe and the posterior section of the hypothalamus of the brain. [Migraine-related headaches may be related to migraine pain or tenderness in the back of the head in women and a dull head pain that becomes worse as the day progresses in men, and is sometimes described as being like a "tight rubber band".(http://en.dafod.net/brain_images/201407/201407_migrain-1_migraine.

Anonymous Patient Answer

Who should consider clinical trials for aura?

We propose to use trial registration in the aura literature. It should be compulsory in trials of medication for primary prevention, especially those with positive results: (i) as a prerequisite to publication; (ii) as a means of communication to the patients when a trial is stopped prematurely, as is often the case in clinical trials; and (iii) to prevent false-positive discoveries from being published later than is warranted.

Anonymous Patient Answer

What are the common side effects of home based self-management and cognitive training changes lives (hobscotch)?

Many adults found using home-based self-management to be a rewarding and helpful experience. The benefits of both program programs had no adverse effects, were generally well tolerated, and were perceived as being relevant to everyday life.

Anonymous Patient Answer
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