Expired Study
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Atlanta, Georgia 30322


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

IRB00075262


NCT ID:

NCT02620514


Secondary ID:


Study Acronym:


Brief Title:

Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Emory University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

5


Number of Groups:

0


Total Enrollment:

77


Enrollment Type:

Actual


Overall Contact Information

Official Name:Heba Iskandar, MD
Principal Investigator
Emory University

Study Dates

Start Date:June 2015
Completion Date:November 1, 2016
Completion Type:Actual
Primary Completion Date:November 1, 2016
Primary Completion Type:Actual
Verification Date:September 2018
Last Changed Date:September 27, 2018
First Received Date:December 1, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in Disease Activity Assessed by the Number of Surgeries
Time Frame:12 Weeks, End of Study (Up to 24 weeks)
Safety Issues:False
Description:Individual participant data will be collected regarding the number of surgeries to monitor IBD remission or progression.
Outcome Type:Secondary Outcome
Measure:Change in Disease Activity Assessed by the Number of Emergency Visits
Time Frame:12 Weeks, End of Study (Up to 24 weeks)
Safety Issues:False
Description:Individual participant data will be collected regarding the number of emergency room visits to monitor IBD remission or progression.
Outcome Type:Secondary Outcome
Measure:Change in Disease Activity Assessed by the Number of Clinic Visits
Time Frame:12 Weeks, End of Study (Up to 24 weeks)
Safety Issues:False
Description:Individual participant data will be collected regarding the number of clinic visits to monitor IBD remission or progression.
Outcome Type:Secondary Outcome
Measure:Change in Disease Activity Assessed by the Number of Admissions
Time Frame:12 Weeks, End of Study (Up to 24 weeks)
Safety Issues:False
Description:Individual participant data will be collected regarding the number of admissions to monitor IBD remission or progression.
Outcome Type:Secondary Outcome
Measure:Change in Hospital Anxiety and Depression Scale (HADS) Score
Time Frame:12 Weeks, End of Study (Up to 24 weeks)
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
Time Frame:12 Weeks, End of Study (Up to 24 weeks)
Safety Issues:False
Description: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 grea
Outcome Type:Secondary Outcome
Measure:Change in Simple Colitis Activity Index (SCAI) Score
Time Frame:12 Weeks, End of Study (Up to 24 weeks)
Safety Issues:False
Description: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 activ
Outcome Type:Secondary Outcome
Measure:Change in Harvey Bradshaw Index (HBI) Score
Time Frame:12 Weeks, End of Study (Up to 24 weeks)
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Change in Modified Morisky Adherence Scale-8 (MMAS-8) Score
Time Frame:12 Weeks, End of Study (Up to 24 weeks)
Safety Issues:False
Description: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).
Outcome Type:Primary Outcome
Measure:Change in Medication Possession Ratio (MPR)
Time Frame:12 Weeks, End of Study (Up to 24 weeks)
Safety Issues:False
Description: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%.

Study Interventions

Intervention Type:Behavioral
Name:Education and Reminders
Description: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.
Arm Name:Health-literacy Assessment + Education and Reminde
Intervention Type:Behavioral
Name:Educational Visit
Description: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.
Arm Name:Health-literacy Assessment + Educational Visit
Intervention Type:Behavioral
Name:Medication Educational Visit
Description: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.
Arm Name:Health-literacy Assessment + Medication Educationa
Intervention Type:Behavioral
Name:Financial Support
Description: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.
Arm Name:Health-literacy Assessment + Financial Support

Study Arms

Study Arm Type:Experimental
Arm Name:Health-literacy Assessment + Financial Support
Description:Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive financial support for medications.
Study Arm Type:Experimental
Arm Name:Health-literacy Assessment + Medication Educational Visit
Description:Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education regarding their medications.
Study Arm Type:Experimental
Arm Name:Health-literacy Assessment + Educational Visit
Description:Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education about IBD.
Study Arm Type:Experimental
Arm Name:Health-literacy Assessment + Education and Reminders
Description:Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants with then complete a 24-week intervention aimed to improve education about inflammatory bowel disease and scheduled nurse phone call reminders.
Study Arm Type:No Intervention
Arm Name:Health-literacy Assessment
Description:Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants with low adherence will continue to one or more intervention groups that address needs based on the results of the survey.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Emory University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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