Back to resultsHealth Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease
Primary Purpose
Inflammatory Bowel Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Coaching
Surveys
Sponsored by
About this trial
This is an interventional supportive care trial for Inflammatory Bowel Diseases
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
Sites / Locations
- Vanderbilt University Medical Center Inflammatory Bowel Disease Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Health Coaching
Control
Arm Description
Participants in the Health Coaching (HC) arm will be assigned to a health coach for a period of 5 months along with receiving usual care (UC). An initial telephone call with the coach will include a discussion about the participant's self-assessment of health perceptions and goals. This self-assessment creates the foundation for the personalization of the behavioral intervention. From this point, the participant schedules the remaining 9 biweekly sessions (30-45 minute in length), for a total of 10 coaching calls over 5 months. Sociodemographic, behavioral, and psychosocial data will be collected over a period of 24 months by surveys and from the medical record.
Participants in the control arm will receive usual care (UC). Sociodemographic, behavioral, and psychosocial data will be collected over a period of 24 months by surveys and from the medical record. To enhance recruitment, those subjects randomized to the usual care control group will be offered to participate in the health coaching arm of the study as well after a period of 6 months. If they refuse, they will continue in the usual care control group.
Outcomes
Primary Outcome Measures
Medication Adherence MPR
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.
Medication Adherence PDC
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03757533
First Posted
November 26, 2018
Last Updated
August 15, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
AbbVie
1. Study Identification
Unique Protocol Identification Number
NCT03757533
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 11, 2019 (Actual)
Primary Completion Date
July 21, 2023 (Actual)
Study Completion Date
July 21, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Health Coaching
Arm Type
Experimental
Arm Description
Participants in the Health Coaching (HC) arm will be assigned to a health coach for a period of 5 months along with receiving usual care (UC). An initial telephone call with the coach will include a discussion about the participant's self-assessment of health perceptions and goals. This self-assessment creates the foundation for the personalization of the behavioral intervention. From this point, the participant schedules the remaining 9 biweekly sessions (30-45 minute in length), for a total of 10 coaching calls over 5 months. Sociodemographic, behavioral, and psychosocial data will be collected over a period of 24 months by surveys and from the medical record.
Arm Title
Control
Arm Type
Other
Arm Description
Participants in the control arm will receive usual care (UC). Sociodemographic, behavioral, and psychosocial data will be collected over a period of 24 months by surveys and from the medical record. To enhance recruitment, those subjects randomized to the usual care control group will be offered to participate in the health coaching arm of the study as well after a period of 6 months. If they refuse, they will continue in the usual care control group.
Intervention Type
Behavioral
Intervention Name(s)
Health Coaching
Intervention Description
10 phone calls with a trained health coach
Intervention Type
Other
Intervention Name(s)
Surveys
Intervention Description
Surveys to assess Behavioural and Psychosocial measures
Primary Outcome Measure Information:
Title
Medication Adherence MPR
Description
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.
Time Frame
24 months
Title
Medication Adherence PDC
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Horst, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center Inflammatory Bowel Disease Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease
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