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Completed

NCT Number: NCT02620514

Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)

The purpose of this is to formally assess health literacy and medication adherence in participants with Inflammatory bowel disease (IBD). The study also aims to improve medication adherence, health-related quality of life, and disease activity through a 24-week intervention.

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Key information

Conditions

Inflammatory Bowel Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn's Disease Digestive System Diseases Disease Gastroenteritis Gastrointestinal Diseases Inflammation Inflammatory Bowel Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ulcerative Colitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Emory Clinic

Atlanta, Georgia, 30322, United States

About this study

The purpose of this study is to formally assess health literacy and medication adherence in participants with Inflammatory bowel disease (IBD). The study also aims to improve medication adherence, health-related quality of life, and disease activity through a 24-week intervention that will include telephone reminders, educational materials, visits to the physician, and financial counseling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • New or existing diagnosis of inflammatory bowel disease (IBD) proven via endoscopy, pathology, and radiology findings
  • Maintained or started on a medication for inflammatory bowel disease at the time of enrollment
  • Ability to speak English
  • Good hearing
  • Phone availability

Exclusion criteria

  • Pregnancy or plans to be pregnant
  • Inability to make own health care decisions
  • Inability to participate in the study phone calls
  • Uncontrolled psychiatric illness
  • Enrollment in another clinical trial outside of the standard clinic IBD registry

Treatment and study plan

Education and Reminders

Behavioral

Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will be provided education materials, and will receive scheduled educational reminder phone calls and text messages at 2,6,12, and 24 weeks from the baseline assessment.

Educational Visit

Behavioral

Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence.Participants will undergo one scheduled visit with a nurse practitioner or physician for education about inflammatory bowel disease (IBD) after the baseline assessment.

Medication Educational Visit

Behavioral

Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will undergo one scheduled visit with a nurse practitioner or physician to discuss medication side effects and medication inadequacy after the baseline assessment.

Financial Support

Behavioral

Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will receive information about patient assistance programs, copay cards, and a scheduled meeting with a social worker or financial advisor.

Primary outcomes

  1. Change in Medication Possession Ratio (MPR)

    Time frame: 12 Weeks, End of Study (Up to 24 weeks)

    The Medication possession Rate (MPR) will be calculated as the amount of medication consumed divided by days in the interval and adherence will be defined as greater than 80%.

  2. Change in Modified Morisky Adherence Scale-8 (MMAS-8) Score

    Time frame: 12 Weeks, End of Study (Up to 24 weeks)

    MMAS-8 is an 8-item scale that has been validated to measure adherence in IBD patients (scoring details are claimed as proprietary information by the scale's copyright holder).

Secondary outcomes

  1. Change in Harvey Bradshaw Index (HBI) Score

    Time frame: 12 Weeks, End of Study (Up to 24 weeks)

    The HBI is a self-administered questionnaire that assesses IBD severity. A score of less than 5 is generally considered to represent clinical remission. A score of 8 to 9 or higher are considered severe disease.

  2. Change in Simple Colitis Activity Index (SCAI) Score

    Time frame: 12 Weeks, End of Study (Up to 24 weeks)

    The SCAI is a way of scoring disease activity in Ulcerative Colitis based on six simple questions about symptoms that gives a number between 0-19 that corresponds to the severity of disease activity. This index gives more detailed information on how active disease is using a number.

  3. Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score

    Time frame: 12 Weeks, End of Study (Up to 24 weeks)

    The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a health-related quality of life tool measuring physical, social, and emotional status. Scores range from 10-70. A lower score indicates poor quality of life while a higher score indicates greater quality of life.

  4. Change in Hospital Anxiety and Depression Scale (HADS) Score

    Time frame: 12 Weeks, End of Study (Up to 24 weeks)

    The Hospital Anxiety and Depression Scale (HADS) is a fourteen item scale that asks participants to describe how they feel. Scores range between 0 and 21. A score of 0 to 7 is normal. A score of 8 to 10 indicates borderline depression/anxiety. A score of 11-21 indicates a case of depression/anxiety.

  5. Change in Disease Activity Assessed by the Number of Admissions

    Time frame: 12 Weeks, End of Study (Up to 24 weeks)

    Individual participant data will be collected regarding the number of admissions to monitor IBD remission or progression.

  6. Change in Disease Activity Assessed by the Number of Clinic Visits

    Time frame: 12 Weeks, End of Study (Up to 24 weeks)

    Individual participant data will be collected regarding the number of clinic visits to monitor IBD remission or progression.

  7. Change in Disease Activity Assessed by the Number of Emergency Visits

    Time frame: 12 Weeks, End of Study (Up to 24 weeks)

    Individual participant data will be collected regarding the number of emergency room visits to monitor IBD remission or progression.

  8. Change in Disease Activity Assessed by the Number of Surgeries

    Time frame: 12 Weeks, End of Study (Up to 24 weeks)

    Individual participant data will be collected regarding the number of surgeries to monitor IBD remission or progression.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study title

Assessment of Health Literacy, Medication Adherence, and a Pilot Multi-component Intervention to Improve Medication Adherence in Patients With Inflammatory Bowel Disease

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2015
Registry last updated
Oct 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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