Clinical trial NCT03757533: Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease
Official title: Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2018-11-29
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Inflammatory bowel disease (IBD) including Crohn's disease (CD) and Ulcerative colitis (UC) is a chronic idiopathic intestinal disorder involving the interplay of environmental, immunomodulatory and genetic causative factors. Treatment for IBD is multimodal and includes lifestyle modification, chronic pharmacotherapy and surgery. Given the need for chronic pharmacotherapy, medication adherence is a crucial therapeutic goal in the management of IBD. In fact, medication non-adherence has been associated with greater risk of relapse and increased healthcare costs.

In a previous study, the investigators found clinically identifiable risk factors for non-adherence for self-injectable biologic medications in a population with moderate to severe CD. These risk factors included smoking, prior biologic use, psychiatric history, and current narcotic use. The primary objective of this study is to use a multidisciplinary team approach that implements a targeted coaching intervention to promote behavioral change and improve medication adherence in adult patients with IBD who are at high risk of non-adherence.


Eligibility criteria: Inclusion Criteria:

* adult patients treated at the Inflammatory Bowel Disease (IBD) clinic at Vanderbilt with Crohn's disease or Ulcerative colitis confirmed by endoscopy or radiology assessment
* currently prescribed a biologic agent (self-injectable or infusion) for management of IBD
* medication dispensing is documented in patient medical record

Exclusion Criteria:

* patients less than 18 years of age
* unstable clinical condition (bleeding, infection, intestinal obstruction, etc.)
* patients who are required to get biologic medication at a specialty pharmacy outside of Vanderbilt University that is not documented in medical record(exclusion due to inability to accurately track prescription refills)
* patients with short bowel syndrome, an ostomy, obstructive disease with strictures, history of tuberculosis, hypersensitivity reaction to anti-TNF agent, cancer, renal failure requiring specific treatment such as dialysis
* patients with severe psychological comorbidity, defined as reported intent to self-harm or harm others or psychiatric hospitalization in the past year
* patients with current alcohol abuse or illegal drug use ascertained by medical history

Primary outcomes:
measure: Medication Adherence MPR
timeFrame: 24 months
measure: Medication Adherence PDC
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Inflammatory Bowel Disease Clinic
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Sara Horst, MD
role: PRINCIPAL_INVESTIGATOR
References: