NCT01536509

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

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

February 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2016

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

4.3 years

First QC Date

February 16, 2012

Last Update Submit

January 24, 2020

Conditions

Crohn's DiseaseUlcerative ColitisIndeterminate ColitisInflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 months

Secondary Outcomes (3)

  • Health-related quality of life

    15 months

  • Disease Severity

    15 months

  • Health care utilization

    15 months

Study Arms (2)

Telehealth Behavioral Treatment

EXPERIMENTAL
Behavioral: Telehealth Behavioral Treatment (TBT)

Education Only

ACTIVE COMPARATOR
Behavioral: Education Only (EO)

Interventions

Telehealth Behavioral Treatment (TBT)BEHAVIORAL

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.

Telehealth Behavioral Treatment
Education Only (EO)BEHAVIORAL

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.

Education Only

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of California San Francisco Benioff Children's Hospital

San Francisco, California, 94143, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Oklahoma State University

Stillwater, Oklahoma, 74074, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Childrens Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Related Publications (1)

  • 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.

    PMID: 40243391DERIVED

MeSH Terms

Conditions

Crohn DiseaseColitis, UlcerativeInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Kevin Hommel, Ph.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

  • Robert Baldassano, M.D.

    Children's Hospital of Philadelphia

    STUDY CHAIR

  • Wallace Crandall, M.D.

    Nationwide Children's Hospital

    STUDY CHAIR

  • Francisco Sylvester, M.D.

    Connecticut Children's Medical Center

    STUDY CHAIR

  • Lee Denson, M.D.

    Children's Hospital Medical Center, Cincinnati

    STUDY CHAIR

  • Michele Maddux, Ph.D.

    Children's Mercy Hospital Kansas City

    STUDY CHAIR

  • Melvin Heyman, M.D.

    University of California San Francisco Benioff Children's Hospital

    STUDY CHAIR

  • David Keljo, M.D.

    University of Pittsburgh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

February 1, 2012

Primary Completion

May 31, 2016

Study Completion

May 31, 2016

Last Updated

January 28, 2020

Record last verified: 2020-01

Locations

US(9)