CLINICAL TRIAL

Health Coaching for Inflammatory Bowel Diseases

1 Prior Treatment
High Risk
Relapsed
Waitlist Available · 18+ · All Sexes · Nashville, TN

This study is evaluating whether a coaching intervention can improve medication adherence in people with inflammatory bowel disease.

See full description

About the trial for Inflammatory Bowel Diseases

Eligible Conditions
Inflammatory Bowel Diseases · Intestinal Diseases

Treatment Groups

This trial involves 2 different treatments. Health Coaching 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.
Surveys
OTHER
Health Coaching
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
Health Coaching
2015
N/A
~1620

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Inflammatory Bowel Diseases or the other condition listed above. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
People who have Crohn's disease or Ulcerative colitis and are treated at the Inflammatory Bowel Disease clinic at Vanderbilt are confirmed to have those diseases by endoscopy or radiology assessment. show original
For people with IBD, a biologic agent is currently prescribed either as a self-injectable or infusion. show original
The medication is documented in the patient's medical record. show original
View All
Odds of Eligibility
High>50%
You meet most of the criteria! It's probably a good idea to apply to 1 other trial just in case this doesn't work out.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 months.
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 Health Coaching will improve 2 primary outcomes in patients with Inflammatory Bowel Diseases. Measurement will happen over the course of 24 months.

Medication Adherence MPR
24 MONTHS
Medication adherence will be measured using the medication possession ratio (MPR). MPR is calculated as the sum of days' supply for all prescription claims divided by the total number of days elapsed during that period.
24 MONTHS
Medication Adherence PDC
24 MONTHS
Medication adherence will be measured using the proportion of days covered (PDC). PDC is calculated as the number of days the patient has medication divided by the total number of days elapsed during that period.
24 MONTHS

Who is running the study

Principal Investigator
S. H.
Sara Horst, Principal Investigator
Vanderbilt University 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 inflammatory bowel diseases a year in the United States?

About 2 million people in the United States receive an IBD diagnosis a year. More than half of the patients receive diagnosis for their first time at a major medical center. At these locations, the diagnostic incidence was higher than the general population. Incidence of IBD increased steadily over the study period.

Anonymous Patient Answer

What causes inflammatory bowel diseases?

IBD can be associated with many hereditary conditions, some drugs (e.g. TNF inhibitors) or chemicals (e.g. bisphenol A), while others appear to be of viral or bacterial origin.

Anonymous Patient Answer

What are the signs of inflammatory bowel diseases?

In children with IBD, signs of chronic diarrhea in particular can be mistaken for an infectious diarrhea, and abdominal pain may be the only clinical manifestation that may lead to an incorrect diagnosis of appendicitis. A complete physical examination of the young patients will reveal all the other signs of IBD.

Anonymous Patient Answer

Can inflammatory bowel diseases be cured?

Currently, several therapies are being used to treat IBD, but the efficacy remains questionable. There is a need for better characterization of mechanisms that lead to chronic inflammation and an improvement in the knowledge of the pathogenetic factors that lead to inflammation.

Anonymous Patient Answer

What are common treatments for inflammatory bowel diseases?

Frequently used medicines, as well as conventional or alternative treatments, are used in patients with inflammatory bowel diseases. Patients need to be informed of the potential side effects of all drugs before their prescriptions. In general, some drugs are preferable to others.

Anonymous Patient Answer

What is inflammatory bowel diseases?

The term 'IBD' covers a wide spectrum of syndromes, both localised and extensive, which lead the clinician to a number of possible diagnoses, both in an individual patient and in a group of syndromes. The approach adopted depends on the clinical and pathological context.

Anonymous Patient Answer

Have there been other clinical trials involving health coaching?

There is only one previous large clinical trial comparing health coaching versus usual care, which found no effect of health coaching or enhanced care on cholesterol levels or behavior. Results from a recent clinical trial did not specifically compare health coaching with a usual-care intervention and the findings may not be generalizable to all care conditions or interventions.

Anonymous Patient Answer

How does health coaching work?

To determine whether health coaching had a significant effect on physical activity and diet, this study investigated individuals who completed 6 months of individualized lifestyle counselling to assist in changing lifestyle habits using an exercise and healthy-living program. Results indicated that participation in this health coaching program led to statistically significant increases in physical activity and dietary changes as measured by self-reported dietary and physical activity indices, as well as significantly greater improvement in a variety of physical health-related outcomes. Data from a recent study indicate that health coaching has a measurable positive impact on lifestyle choices in this frail, elderly patient population.

Anonymous Patient Answer

Does inflammatory bowel diseases run in families?

Recent findings suggest that one in 10 IBD pedigrees in this study may reflect a familial component. Recent findings are supported by previous studies suggesting a significant genetic contribution to the familial clustering of IBD. Genetic markers that are already known to be susceptibility factors for IBD may be valuable to stratify families for increased IBD incidence and more rapid progression of the disease.

Anonymous Patient Answer

What is the average age someone gets inflammatory bowel diseases?

There is a positive correlation between the average age of someone diagnosed with Crohn's disease and Ulcerative Colitis. It was also found that there is a positive association between females and U.S. citizens. The average age of someone diagnosed with Crohn's disease was 39 years old. Crohn's patients, female, and U.S. citizens were diagnosed most often. Those with Ulcerative Colitis presented with the lowest average age of diagnosis.

Anonymous Patient Answer

Has health coaching proven to be more effective than a placebo?

Health coaching and other approaches that encourage people to take action to improve their health and minimize the risks of disease appear to have potential to be an effective method for helping patients increase their levels of physical activity.

Anonymous Patient Answer

What is the latest research for inflammatory bowel diseases?

There is a very large amount of new research into IRG's and the inflammatory bowel diseases (IBDS). The amount of new research and funding should remain constant. This should allow for a better understanding of the diseases and more treatment options. This research will hopefully lead to a better understanding of the diseases.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Inflammatory Bowel Diseases by sharing your contact details with the study coordinator.