title: The Telehealth Enhancement of Adherence to Medication (TEAM) in pediatric IBD trial: Design and methodology.
abstract: Medication nonadherence is a significant health care issue requiring regular behavioral treatment. Lack of sufficient health care resources and patient/family time commitment for weekly treatment are primary barriers to receiving appropriate self-management support. We describe the methodology of the Telehealth Enhancement of Adherence to Medication (TEAM) trial for medication nonadherence in pediatric inflammatory bowel disease (IBD). For this trial, participants 11-18 years of age will be recruited from seven pediatric hospitals and will complete an initial 4-week run in to assess adherence to a daily medication. Those who take less than 90% of their prescribed medication will be randomized. A total of 194 patients with IBD will be randomized to either a telehealth behavioral treatment (TBT) arm or education only (EO) arm. All treatments will be delivered via telehealth video conferencing. The patients will be assessed at baseline, post-treatment, 3, 6, and 12 months. We anticipate that participants in the TBT arm will demonstrate a statistically significant improvement at post-treatment and 3-, 6-, and 12-month follow-up compared to participants in the EO arm for both medication adherence and secondary outcomes (i.e., disease severity, patient quality of life, and health care utilization). If efficacious, the TEAM intervention could be disseminated broadly and reduce health care access barriers so that the patients could receive much needed self-management intervention.
authors.affiliation: Cincinnati Children's Hospital Medical Center, United States; University of Cincinnati College of Medicine, United States. Electronic address: kevin.hommel@cchmc.org.
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Hommel
authors.affiliation: Auburn University, United States.
authors.forename: Wendy N
authors.initials: WN
authors.lastname: Gray
authors.affiliation: Cincinnati Children's Hospital Medical Center, United States.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Hente
authors.affiliation: Cincinnati Children's Hospital Medical Center, United States.
authors.forename: Katherine
authors.initials: K
authors.lastname: Loreaux
authors.affiliation: Cincinnati Children's Hospital Medical Center, United States; University of Cincinnati College of Medicine, United States.
authors.forename: Richard F
authors.initials: RF
authors.lastname: Ittenbach
authors.affiliation: Children's Mercy Hospitals and Clinics, United States; University of Missouri Kansas City School of Medicine, United States.
authors.forename: Michele
authors.initials: M
authors.lastname: Maddux
authors.affiliation: Children's Hospital of Philadelphia, United States; University of Pennsylvania School of Medicine, United States.
authors.forename: Robert
authors.initials: R
authors.lastname: Baldassano
authors.affiliation: University of North Carolina, United States.
authors.forename: Francisco
authors.initials: F
authors.lastname: Sylvester
authors.affiliation: Nationwide Children's Hospital, United States; Ohio State University College of Medicine, United States.
authors.forename: Wallace
authors.initials: W
authors.lastname: Crandall
authors.affiliation: University of Cincinnati, United States.
authors.forename: Charles
authors.initials: C
authors.lastname: Doarn
authors.affiliation: UCSF Benioff Children's Hospital, United States; University of California, San Francisco, United States.
authors.forename: Melvin B
authors.initials: MB
authors.lastname: Heyman
authors.affiliation: Children's Hospital of Pittsburgh, United States; University of Pittsburgh School of Medicine, United States.
authors.forename: David
authors.initials: D
authors.lastname: Keljo
authors.affiliation: Cincinnati Children's Hospital Medical Center, United States; University of Cincinnati College of Medicine, United States.
authors.forename: Lee A
authors.initials: LA
authors.lastname: Denson
mesh_terms: D000293:Adolescent; D002648:Child; D005260:Female; D006296:Health Services / Q000706:statistics & numerical data; D006801:Humans; D015212:Inflammatory Bowel Diseases / Q000523:psychology / Q000628:therapy*; D020407:Internet; D008297:Male; D055118:Medication Adherence; D010353:Patient Education as Topic; D011788:Quality of Life; D017010:Reminder Systems; D012107:Research Design; D012648:Self Care; D012720:Severity of Illness Index; D017216:Telemedicine / Q000379:methods*; D013689:Telephone
keywords: Adherence; Behavioral; Inflammatory bowel disease; Pediatrics; Telehealth