Inflammatory Bowel DiseaseNCT02620514
Medication Adherence in Patients With Inflammatory Bowel Disease (IBD)
A study testing Education and Reminders, Educational Visit and Medication Educational Visit in people with Inflammatory Bowel Disease and Crohn's Disease, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Education and Reminders, Educational Visit and Medication Educational Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 1 Nov 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Health Literacy, Medication Adherence, and a Pilot Multi-component Intervention to Improve Medication Adherence in Patients With Inflammatory Bowel Disease
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.
Read the detailed description
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.
- Being tested
- Education and Reminders, Educational Visit, Medication Educational Visit, Financial Support
- Keywords
- Digestive Disease and Disorders, Inflammation
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Digestive System Diseases, Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and RemindersBehavioural
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 VisitBehavioural
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 VisitBehavioural
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 SupportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Behavioral: Financial Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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).
Measured: 12 Weeks, End of Study (Up to 24 weeks)
Secondary outcomes (8)
Change in Harvey Bradshaw Index (HBI) Score
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.
Measured: 12 Weeks, End of Study (Up to 24 weeks)
Change in Simple Colitis Activity Index (SCAI) Score
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.
Measured: 12 Weeks, End of Study (Up to 24 weeks)
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
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.
Measured: 12 Weeks, End of Study (Up to 24 weeks)
Change in Hospital Anxiety and Depression Scale (HADS) Score
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.
Measured: 12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Admissions
Individual participant data will be collected regarding the number of admissions to monitor IBD remission or progression.
Measured: 12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Clinic Visits
Individual participant data will be collected regarding the number of clinic visits to monitor IBD remission or progression.
Measured: 12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Emergency Visits
Individual participant data will be collected regarding the number of emergency room visits to monitor IBD remission or progression.
Measured: 12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Surgeries
Individual participant data will be collected regarding the number of surgeries to monitor IBD remission or progression.
Measured: 12 Weeks, End of Study (Up to 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startJun 2015
- Primary completion1 Nov 2016
- Study completion1 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Iskandar, Emory University
- Investigators
- Heba Iskandar, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620514
- Sponsor's protocol ID
- IRB00075262
- Status last verified
- Sep 2018
- First submitted
- 1 Dec 2015
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Health Literacy, Medication Adherence, and a Pilot Multi-component Intervention to Improve Medication Adherence in Patients With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02620514
- Acronym / sponsor ID
- IRB00075262
- Keywords
- Digestive Disease and Disorders, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Education and RemindersParticipants 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. |
| Health-literacy Assessment + Educational Visit | Experimental | Behavioral: Educational VisitParticipants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education about IBD. |
| Health-literacy Assessment + Medication Educational Visit | Experimental | Behavioral: Medication Educational VisitParticipants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive education regarding their medications. |
| Health-literacy Assessment + Financial Support | Experimental | Behavioral: Financial SupportParticipants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will then receive financial support for medications. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Education and RemindersParticipants 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. | Behavioural | Health-literacy Assessment + Education and Reminders |
| Educational VisitParticipants 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. | Behavioural | Health-literacy Assessment + Educational Visit |
| Medication Educational VisitParticipants 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. | Behavioural | Health-literacy Assessment + Medication Educational Visit |
| Financial SupportParticipants 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. | Behavioural | Health-literacy Assessment + Financial Support |
Primary outcome
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%.
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).
8 secondary outcomes
Change in Harvey Bradshaw Index (HBI) Score
Time frame: 12 Weeks, End of Study (Up to 24 weeks)
Change in Simple Colitis Activity Index (SCAI) Score
Time frame: 12 Weeks, End of Study (Up to 24 weeks)
Change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score
Time frame: 12 Weeks, End of Study (Up to 24 weeks)
Change in Hospital Anxiety and Depression Scale (HADS) Score
Time frame: 12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Admissions
Time frame: 12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Clinic Visits
Time frame: 12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Emergency Visits
Time frame: 12 Weeks, End of Study (Up to 24 weeks)
Change in Disease Activity Assessed by the Number of Surgeries
Time frame: 12 Weeks, End of Study (Up to 24 weeks)
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 1 Oct 2018.
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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.
Heba Iskandar, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Reminders, Educational Visit and Medication Educational Visit in people with Inflammatory Bowel Disease and Crohn's Disease, run by Emory University 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 5 inclusion and 5 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 1 Oct 2018. 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?
Change in Medication Possession Ratio (MPR) (time frame: 12 Weeks, End of Study (Up to 24 weeks)). 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?
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 1 Oct 2018.