TEAM: Improving Medication Adherence in Pediatric Inflammatory Bowel Disease

Sponsor

Children's Hospital Medical Center, Cincinnati (Other)

Overall Status

Completed

CT.gov ID

NCT01536509

Collaborator

(none)

140

Enrollment

Locations

Arms

51.9

Duration (Months)

15.6

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease Ulcerative Colitis Indeterminate Colitis Inflammatory Bowel Disease	Behavioral: Telehealth Behavioral Treatment (TBT) Behavioral: Education Only (EO)	N/A

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

Study Type:

Interventional

Actual Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Telehealth Enhancement of Adherence to Medication in Pediatric Inflammatory Bowel Disease

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

May 31, 2016

Actual Study Completion Date :

May 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telehealth Behavioral Treatment	Behavioral: 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.
Active Comparator: Education Only	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: Telehealth Behavioral Treatment

Behavioral: 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.

Active Comparator: Education Only

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Medication adherence [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.

Secondary Outcome Measures

Health-related quality of life [15 months]
The IMPACT III measure will be used for this assessment. This is an IBD-specific HRQOL assessment tool.
Disease Severity [15 months]
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.
Health care utilization [15 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco Benioff Children's Hospital	San Francisco	California	United States	94143
2	Connecticut Children's Medical Center	Hartford	Connecticut	United States	06106
3	Children's Mercy Hospitals and Clinics	Kansas City	Missouri	United States	64108
4	University of Cincinnati	Cincinnati	Ohio	United States	45221
5	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
6	Nationwide Children's Hospital	Columbus	Ohio	United States	43205
7	Oklahoma State University	Stillwater	Oklahoma	United States	74074
8	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
9	Childrens Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania	United States	15224

Sponsors and Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

Principal Investigator: Kevin Hommel, Ph.D., Children's Hospital Medical Center, Cincinnati
Study Chair: 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