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"N of 1" Trials

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The Trials are experiments designed by both patients and clincians to determine how individual, IBD patients respond to specific treatments or interventions.

The goal of this prototype is to develop data collection tools, protocols and reports that physicians and patients can use to provide highly specific, personalized answers to questions that will help decide which combination of treatments and lifestyle modifications work best for the patient.

If a patient and physician qualify and agree to participate in an N of 1 prototype study, they would participate by: 

  1. The participating physician and a C3N researcher meet with the patient to discuss and identify a quesiton related to his/her disease that he/she would like to explore.  An example: "Do symptoms increase when I eat certain foods?"
  2. The research team and physician work with the patient to design an experiment that will help answer the patient's question.
  3. The patient participates in a standard disease education program using an educational CD to help the patient better understand his/her disease.
  4. The patient learns how to use data collection tools that will enable them to record symptoms on a daily basis.  These include: SMS text message, secure email, and web survey.
  5. Approximately every other week, meetings or phone calls with the physician, patient and the C3N researchers are set up to discuss progress, address questions and review the patient's data.
  6. During the study the patient receives reports and graphs with his/her data via secure email or in person with their doctor.

Comments

The C3N is Rewriting the Patient-Doctor Script

Submitted by Molly Pace-Scrivener on Thu, 2012-01-12 15:42.

Stanford's Medicine X, a catalyst for new ideas about the future of medicine and health care, talked with the C3N Project, as well as one of our N of 1 Trials participants - Emily Blosser.  Take a look at Medicine X's insights into this exciting project, and hear more on an encouraging patient experience - read the article here.

N of 1 Trials: A Physicians Perspective

Submitted by Christina Bennett on Tue, 2011-08-30 12:19.
 
An Interview with Dr. Shezhad Saeed
To learn more about N of 1 Trials as experienced by a physician, we interviewed Dr. Shehzad Saeed, the Clinical Director of the Schubert-Martin Inflammatory Bowel Disease Center, who has now collaborated with two patients in N of 1 Trials. The Trials are experiments designed by both patients and clinicians to determine how individual, IBD patients respond to specific treatments or interventions. By collecting data on lifestyle changes and IBD treatments, researchers and physicians hope to be able to obtain more precise answers about how to select among treatment options.
 
 
What has the experience been like as a physician and what are your thoughts about practicality?

"The first N of 1 Trial prototype was comprised of a young teenager, recently diagnosed with Crohn's disease, who is an avid long distance runner. The tracked intervention was biological therapy and the patient's response to the therapy with improvement in clinical symptoms and, critically for him, the ability to resume his pre-morbid running schedule. We started with daily tracking of bowel movements, fever recurrence (a prominent symptom prior to starting biological therapy), abdominal pain, and a running log, followed by weekly measures of pain and fatigue, and monthly quality of life. Midway through the trial, we dropped the tracking of fever since that abated right after the intervention. These data points were gathered through daily, weekly and monthly texting, as well as personalized surveys.  Data collection was easy to conduct based on both the patient and research team's feedback.

The second trial is comprised of a young preteen with diarrhea as the predominant symptom of her Crohn's disease. The family is interested in tracking her response to a probiotic intervention and [the trial] consisted of similar weekly and monthly measures as patient 1, but with a different set of daily measures like, diarrhea, urgency and pain. This trial is currently in week two of the intervention and data is being collected in a similar fashion [as the first trial], but utilizing secure email with links to personalized surveys."


What have you learned from participating in conducting these trials?

"These trials have demonstrated several things:

  • N of 1 Trials need to be conducted with an activated patient and family who have knowledge of technology and are motivated to use technological innovations.
  • There needs to be readjustments in data collection as symptoms change (as we did for fever).
  • We learned that patient encounters were different than usual encounters in that, having patient information beforehand creates more time for discussions based on self-management, goals moving forward etc., rather than collecting medical information alone.
  • Lastly, the transformed encounter allows the teams to provide more patient driven information and tools for targeted patient populations (e.g. transition of tools for older adolescents, providing symptom feedback to patients and families etc.).

We are very much looking forward to further learnings as the second trial progresses."