NCT02620514

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

1.4 years

First QC Date

December 1, 2015

Last Update Submit

September 27, 2018

Conditions

Inflammatory Bowel DiseaseCrohn's DiseaseUlcerative Colitis

Keywords

Digestive Disease and DisordersInflammation

Outcome Measures

Primary Outcomes (2)

  • Change in Medication Possession Ratio (MPR)

    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%.

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

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

    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).

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

Secondary Outcomes (8)

  • Change in Harvey Bradshaw Index (HBI) Score

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

  • Change in Simple Colitis Activity Index (SCAI) Score

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

  • Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score

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

  • Change in Hospital Anxiety and Depression Scale (HADS) Score

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

  • Change in Disease Activity Assessed by the Number of Admissions

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

  • +3 more secondary outcomes

Study Arms (5)

Health-literacy Assessment

NO INTERVENTION

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.

Health-literacy Assessment + Education and Reminders

EXPERIMENTAL

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.

Behavioral: Education and Reminders

Health-literacy Assessment + Educational Visit

EXPERIMENTAL

Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education about IBD.

Behavioral: Educational Visit

Health-literacy Assessment + Medication Educational Visit

EXPERIMENTAL

Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education regarding their medications.

Behavioral: Medication Educational Visit

Health-literacy Assessment + Financial Support

EXPERIMENTAL

Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive financial support for medications.

Behavioral: Financial Support

Interventions

Education and RemindersBEHAVIORAL

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.

Health-literacy Assessment + Education and Reminders
Educational VisitBEHAVIORAL

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.

Health-literacy Assessment + Educational Visit
Medication Educational VisitBEHAVIORAL

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.

Health-literacy Assessment + Medication Educational Visit
Financial SupportBEHAVIORAL

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.

Health-literacy Assessment + Financial Support

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, UlcerativeDigestive System DiseasesDiseaseInflammation

Interventions

Educational StatusFinancial Support

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesIntestinal DiseasesColitisColonic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsEconomicsHealth Care Economics and Organizations

Study Officials

  • Heba Iskandar, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 3, 2015

Study Start

June 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

October 1, 2018

Record last verified: 2018-09

Locations

US(1)