Clinical trial NCT01253733: MD2Me - Texting to Promote Chronic Disease Management
Official title: TAHLC - Texting to Promote Adolescent Health Liaisons and Chronic Disease Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Inflammatory Bowel Disease
Type 1 Diabetes
Chronic Disease Management
Keywords: Cystic Fibrosis
Inflammatory Bowel Disease
Type 1 Diabetes
Chronic Disease Management
SMS
Text messages
Internet
Healthcare Interactions
Lead sponsor: Huang, Jeannie, M.D.
Sponsor class: INDIV
Collaborators: name: University of California, San Diego
First posted: 2010-12-03
Enrollment: 81
Sex: ALL
Minimum age (years): 14
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: UCSD researchers are conducting a study aimed to develop and evaluate a chronic disease self management web and text message based program on health-related self-efficacy and frequency of adolescent-conducted healthcare interactions. We hypothesize that users of the program will demonstrate greater gains between baseline and 8 month measures of health related self-efficacy and adolescent-conducted healthcare interactions as compared to the usual care comparison group.

Detailed description: The MD2Me study (or also known as TAHLC), sponsored by the National Institutes of Health is a 2-year randomized controlled trial to develop and test a text message and Internet based intervention among adolescents and young adults with cystic fibrosis, type 1 diabetes, or inflammatory bowel disease. Adolescents and young adults have been a difficult population to engage in healthcare. It is estimated that 1 in 5 adolescents do not get the healthcare they need. Interventions must address how the healthcare system can engage adolescents with chronic disease and provide opportunities to discuss health-related matters and improve disease outcomes.

This study will help fill multiple gaps in the literature by exploring the utility of a push AND pull SMS texting-based application for chronic disease management among youth. Based on social cognitive theory, the intervention will use accessible technology to promote disease management among adolescents with chronic disease as they transition to adult care. The popularity and usage of SMS already demonstrated by adolescents suggests notable promise for the SMS-based TAHLC program to promote chronic disease self-management and healthcare engagement with substantial positive impacts on health among youth with chronic disease.

Eligibility criteria: Inclusion Criteria:

* ages 14 - 22 years
* have cystic fibrosis, type 1 diabetes, or inflammatory bowel disease for at least 6 months
* have access to the internet
* speak English
* has a parent that speaks English or Spanish (if primary participant is under 18)
* willingness to attend assessment visits

Exclusion Criteria:

* pregnant or have children
* have a history of substance abuse or other psychiatric disorder that would impair compliance with study protocol

Primary outcomes:
measure: Health related self-efficacy
timeFrame: 8 months
Secondary outcomes:
measure: Health knowledge
timeFrame: 8 months
measure: Health literacy
timeFrame: 8 months
measure: Quality of Life
timeFrame: 8 Months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Jeannie Huang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang JS, Terrones L, Tompane T, Dillon L, Pian M, Gottschalk M, Norman GJ, Bartholomew LK. Preparing adolescents with chronic disease for transition to adult care: a technology program. Pediatrics. 2014 Jun;133(6):e1639-46. doi: 10.1542/peds.2013-2830. Epub 2014 May 19.