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Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease

NCT03757533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-08-16

No results posted yet for this study

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.

Conditions

  • Inflammatory Bowel Diseases

Interventions

BEHAVIORAL

Health Coaching

10 phone calls with a trained health coach

OTHER

Surveys

Surveys to assess Behavioural and Psychosocial measures

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Sara Horst, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-11
Primary Completion
2023-07-21
Completion
2023-07-21

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03757533 on ClinicalTrials.gov