Clinical trial NCT01536509: Improving Medication Adherence in Pediatric Inflammatory Bowel Disease
Official title: Telehealth Enhancement of Adherence to Medication in Pediatric Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Ulcerative Colitis
Indeterminate Colitis
Inflammatory Bowel Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2012-02-22
Enrollment: 140
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Diagnosis of pervasive developmental disorder in patient or parent
* Diagnosis of serious mental illness (e.g., schizophrenia) in patient or parent

Primary outcomes:
measure: Medication adherence
timeFrame: 15 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: 15 months
measure: Disease Severity
timeFrame: 15 months
measure: Health care utilization
timeFrame: 15 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Benioff Children's Hospital
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Childrens Hospital of Pittsburgh of UPMC
state: Pennsylvania
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Kevin Hommel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Robert Baldassano, M.D.
role: STUDY_CHAIR
affiliation: Nationwide Children's Hospital
name: Wallace Crandall, M.D.
role: STUDY_CHAIR
affiliation: Connecticut Children's Medical Center
name: Francisco Sylvester, M.D.
role: STUDY_CHAIR
affiliation: Children's Hospital Medical Center, Cincinnati
name: Lee Denson, M.D.
role: STUDY_CHAIR
affiliation: Children's Mercy Hospital Kansas City
name: Michele Maddux, Ph.D.
role: STUDY_CHAIR
affiliation: University of California San Francisco Benioff Children's Hospital
name: Melvin Heyman, M.D.
role: STUDY_CHAIR
affiliation: University of Pittsburgh
name: David Keljo, M.D.
role: STUDY_CHAIR
References: