Crohn's DiseaseTEAMNCT01536509
Improving Medication Adherence in Pediatric Inflammatory Bowel Disease
A study testing Telehealth Behavioral Treatment (TBT) and Education Only (EO) in people with Crohn's Disease and Ulcerative Colitis, run by Children's Hospital Medical Center, Cincinnati at 9 sites in United States.
Trial summary
The purpose of the study is to test an online behavioral intervention to improve medication adherence in children diagnosed with Inflammatory Bowel Disease. Interested families will be monitored for four weeks to determine how frequently their child's IBD medication is taken. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis
- What is being tested?
- Telehealth Behavioral Treatment (TBT) and Education Only (EO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2012to 31 May 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient is currently seen for care at one of the collaborating research sites: Cincinnati Children's Hospital Medical Center, Connecticut Children's Medical Center, Children's Hospital of Philadelphia, Nationwide Children's Hospital, University of California San Francisco Benioff Children's Hospital, or Children's Mercy Hospitals and Clinics
- Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis
- Patient age between 11-18 years
- Patient currently living at home
- Patient currently prescribed at least one daily oral immunomodulator (e.g., 6-MP/azathioprine) and/or 5-ASA (e.g., mesalamine)in pill form
- English fluency for patient and parents
- Inclusion for Randomization: <90% adherence to immunomodulator and/or 5-ASA during four week run-in phase
Who cannot join
- Diagnosis of pervasive developmental disorder in patient or parent
- Diagnosis of serious mental illness (e.g., schizophrenia) in patient or parent
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Cincinnati
Cincinnati, Ohio, 45221
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Childrens Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
University of California San Francisco Benioff Children's Hospital
San Francisco, California, 94143
Oklahoma State University
Stillwater, Oklahoma, 74074
About this study
Official title: Telehealth Enhancement of Adherence to Medication in Pediatric Inflammatory Bowel Disease
The purpose of the study is to test an online behavioral intervention to improve medication adherence in children diagnosed with Inflammatory Bowel Disease. Interested families will be monitored for four weeks to determine how frequently their child's IBD medication is taken. Patient's taking less than 90% of medications will be randomized to one of two intervention conditions to complete intervention sessions online. The study consists of 4 online intervention sessions with topics differing by condition and 5 online assessments to complete quality of life questionnaires over a 14 month time frame.
Read the detailed description
The purpose of the study is to test the efficacy of a telehealth behavioral treatment (TBT) protocol to improve medication adherence in children and adolescents with IBD via a randomized controlled clinical trial. Participants in the TBT condition will be compared to those in an education only (EO) condition. In order to examine clinical significance of the intervention, treatment outcomes will include disease severity, HRQOL, and health care utilization. This randomized controlled clinical trial for nonadherence to medication randomizes participants to either the TBT or EO intervention condition, with assessments occurring at baseline, post-treatment, and 3-, 6-, and 12-month follow-up. Both conditions will participate in a self-guided educational intervention during week 6 of enrollment, with three intervention sessions at weeks 8, 10, and 12. A 4-week run-in phase immediately preceding randomization is utilized to establish participants' baseline adherence. Assessments will occur at week 5 (Baseline Assessment 1), week 14 (Post-treatment Assessment 2), and 3-, 6-, and 12-month post-treatment follow-up (Assessments 3, 4, and 5). Intervention topics will differ for each condition; however, the frequency of contact is equivalent across conditions.
- Being tested
- Telehealth Behavioral Treatment (TBT), Education Only (EO)
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Behavioral Treatment (TBT)Behavioural
Families in the TBT condition will receive three individually-tailored behavioral intervention sessions in addition to the online education intervention with 1) guided problem-solving and behavior management training tailored to the unique needs and/or barriers of the family, and 2) discussion of the patient's adherence since the previous session. In addition, patients in the TBT condition will be signed up for text message reminder service offered free of charge via www.mymedschedule.com. These are generic reminder text messages are used to assist with adherence in adolescents. Intervention sessions will be conducted via telehealth delivery with trained postdoctoral psychology fellows or masters-level graduates using webcams, supplied by the study, and SkypeTM free software.
Education Only (EO)Behavioural
Families in the EO condition will receive three individual sessions in addition to the online education intervention to review 1) online educational intervention material to answer questions participants have, 2) educational brochures from the Crohn's and Colitis Foundation of America (CCFA), which contain additional information (e.g., Guide for Parents, Living with IBD, Guide for Kids and Teenagers), and 3) general healthy lifestyle recommendations (e.g., sleep, exercise, etc.). Sessions will be conducted via telehealth delivery with trained postdoctoral clinical psychology fellows or masters-level graduates using webcams, supplied by the study, and SkypeTM free software.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth Behavioral Treatment | Experimental | Not described Receives: Behavioral: Telehealth Behavioral Treatment (TBT) |
| Education Only | Active comparator | Not described Receives: Behavioral: Education Only (EO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication adherence
Medication adherence will be measured using electronic monitoring. The specific device is the MEMS TrackCap. Immunomodulators and/or mesalamine medications will be assessed.
Measured: 15 months
Secondary outcomes (3)
Health-related quality of life
The IMPACT III measure will be used for this assessment. This is an IBD-specific HRQOL assessment tool.
Measured: 15 months
Disease Severity
The Pediatric Crohn's Disease Activity Index (PCDAI) and Partial Harvey-Bradshaw Index (PHBI) will be used to assess disease severity in patients with Crohn's disease. The Pediatric Ulcerative Colitis Index (PUCAI) will be used in patients with ulcerative colitis.
Measured: 15 months
Health care utilization
Health care utilization will be assessed via medical chart review and all IBD-related hospital admissions, procedures, communications, clinic appointments, and other encounters with the health care system will serve as indicators of utilization.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completion31 May 2016
- Study completion31 May 2016
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 Crohn's DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Hommel, Ph.D., Principal investigator, Children's Hospital Medical Center, CincinnatiRobert Baldassano, M.D., Study chair, Children's Hospital of PhiladelphiaWallace Crandall, M.D., Study chair, Nationwide Children's HospitalFrancisco Sylvester, M.D., Study chair, Connecticut Children's Medical CenterLee Denson, M.D., Study chair, Children's Hospital Medical Center, CincinnatiMichele Maddux, Ph.D., Study chair, Children's Mercy Hospital Kansas CityMelvin Heyman, M.D., Study chair, University of California San Francisco Benioff Children's HospitalDavid Keljo, M.D., Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536509
- Sponsor's protocol ID
- R01HD067174
- Acronym
- TEAM
- Status last verified
- Jan 2020
- First submitted
- 16 Feb 2012
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
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 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Enhancement of Adherence to Medication in Pediatric Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01536509
- Acronym / sponsor ID
- TEAM / R01HD067174
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 31 May 2016 (actual)
- First posted
- 22 Feb 2012 (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 the study is to test an online behavioral intervention to improve medication adherence in children diagnosed with Inflammatory Bowel Disease. Interested families will be monitored for four weeks to determine how frequently their child's IBD medication is taken. Patient's taking less than 90% of medications will be randomized to one of two intervention conditions to complete intervention sessions online. The study consists of 4 online intervention sessions with topics differing by condition and 5 online assessments to complete quality of life questionnaires over a 14 month time frame.
Detailed description
The purpose of the study is to test the efficacy of a telehealth behavioral treatment (TBT) protocol to improve medication adherence in children and adolescents with IBD via a randomized controlled clinical trial. Participants in the TBT condition will be compared to those in an education only (EO) condition. In order to examine clinical significance of the intervention, treatment outcomes will include disease severity, HRQOL, and health care utilization. This randomized controlled clinical trial for nonadherence to medication randomizes participants to either the TBT or EO intervention condition, with assessments occurring at baseline, post-treatment, and 3-, 6-, and 12-month follow-up. Both conditions will participate in a self-guided educational intervention during week 6 of enrollment, with three intervention sessions at weeks 8, 10, and 12. A 4-week run-in phase immediately preceding randomization is utilized to establish participants' baseline adherence. Assessments will occur at week 5 (Baseline Assessment 1), week 14 (Post-treatment Assessment 2), and 3-, 6-, and 12-month post-treatment follow-up (Assessments 3, 4, and 5). Intervention topics will differ for each condition; however, the frequency of contact is equivalent across conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth Behavioral Treatment | Experimental | Behavioral: Telehealth Behavioral Treatment (TBT) |
| Education Only | Active comparator | Behavioral: Education Only (EO) |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patient is currently seen for care at one of the collaborating research sites: Cincinnati Children's Hospital Medical Center, Connecticut Children's Medical Center, Children's Hospital of Philadelphia, Nationwide Children's Hospital, University of California San Francisco Benioff Children's Hospital, or Children's Mercy Hospitals and Clinics
- Patient diagnosed with Crohn's disease, ulcerative colitis, or indeterminate colitis
- Patient age between 11-18 years
- Patient currently living at home
- Patient currently prescribed at least one daily oral immunomodulator (e.g., 6-MP/azathioprine) and/or 5-ASA (e.g., mesalamine)in pill form
Key exclusion criteria (2 listed)
- Diagnosis of pervasive developmental disorder in patient or parent
- Diagnosis of serious mental illness (e.g., schizophrenia) in patient or parent
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 |
|---|---|---|
| Telehealth Behavioral Treatment (TBT)Families in the TBT condition will receive three individually-tailored behavioral intervention sessions in addition to the online education intervention with 1) guided problem-solving and behavior management training tailored to the unique needs and/or barriers of the family, and 2) discussion of the patient's adherence since the previous session. In addition, patients in the TBT condition will be signed up for text message reminder service offered free of charge via www.mymedschedule.com. These are generic reminder text messages are used to assist with adherence in adolescents. Intervention sessions will be conducted via telehealth delivery with trained postdoctoral psychology fellows or masters-level graduates using webcams, supplied by the study, and SkypeTM free software. | Behavioural | Telehealth Behavioral Treatment |
| Education Only (EO)Families in the EO condition will receive three individual sessions in addition to the online education intervention to review 1) online educational intervention material to answer questions participants have, 2) educational brochures from the Crohn's and Colitis Foundation of America (CCFA), which contain additional information (e.g., Guide for Parents, Living with IBD, Guide for Kids and Teenagers), and 3) general healthy lifestyle recommendations (e.g., sleep, exercise, etc.). Sessions will be conducted via telehealth delivery with trained postdoctoral clinical psychology fellows or masters-level graduates using webcams, supplied by the study, and SkypeTM free software. | Behavioural | Education Only |
Primary outcome
Medication adherence
Time frame: 15 months
Medication adherence will be measured using electronic monitoring. The specific device is the MEMS TrackCap. Immunomodulators and/or mesalamine medications will be assessed.
3 secondary outcomes
Health-related quality of life
Time frame: 15 months
Disease Severity
Time frame: 15 months
Health care utilization
Time frame: 15 months
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 28 Jan 2020.
- 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.
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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.
Kevin Hommel, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
Robert Baldassano, M.D. study chair
Children's Hospital of Philadelphia
Wallace Crandall, M.D. study chair
Nationwide Children's Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Behavioral Treatment (TBT) and Education Only (EO) in people with Crohn's Disease and Ulcerative Colitis, run by Children's Hospital Medical Center, Cincinnati at 9 sites 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 7 inclusion and 2 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 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 (time frame: 15 months). 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 NCT01536509, 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 28 Jan 2020.