Inflammatory Bowel DiseasesNCT03757533
Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease
A study testing Health Coaching and Surveys in people with Inflammatory Bowel Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Health Coaching and Surveys
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2019to 21 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center Inflammatory Bowel Disease Clinic
Nashville, Tennessee, 37212
About this study
Official title: Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease: A Prospective Randomized Study
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
- Being tested
- Health Coaching, Surveys
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
10 phone calls with a trained health coach
SurveysOther
Surveys to assess Behavioural and Psychosocial measures
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | 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. Receives: Behavioral: Health Coaching; Other: Surveys |
| Control | Other | 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. Receives: Other: Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start11 Jun 2019
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Sara Horst, Vanderbilt University Medical Center
- Investigators
- Sara Horst, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757533
- Sponsor's protocol ID
- 182030
- Status last verified
- Aug 2023
- First submitted
- 26 Nov 2018
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Coaching as a Tool for Improving Medication Adherence in Adult Patients With Inflammatory Bowel Disease: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT03757533
- Acronym / sponsor ID
- 182030
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Behavioral: Health Coaching, Other: SurveysParticipants 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. |
| Control | Other | Other: SurveysParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Coaching10 phone calls with a trained health coach | Behavioural | Health Coaching |
| SurveysSurveys to assess Behavioural and Psychosocial measures | Other | Control, Health Coaching |
Primary outcome
Medication Adherence MPR
Time frame: 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.
Medication Adherence PDC
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Individual participant dataSharing planned: No
Related trials for Inflammatory Bowel Diseases
Not yet recruitingObservational study
Non-Invasive Biomarker Monitoring in UC on Biologics
Ulcerative Colitis
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Clinical and Basic Investigations Into Hermansky-Pudlak Syndrome
Hermansky-Pudlak Syndrome (HPS)
RecruitingPhase 1
A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis
Colitis, Ulcerative
Not yet recruitingPhase 2
Oral N-acetylglucosamine in Crohn's Disease
Crohns Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Horst, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching and Surveys in people with Inflammatory Bowel Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication Adherence MPR (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03757533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.