MD2Me - Texting to Promote Chronic Disease Management

This study has been completed.
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Huang, Jeannie, M.D.
ClinicalTrials.gov Identifier:
NCT01253733
First received: November 30, 2010
Last updated: September 26, 2012
Last verified: September 2012

November 30, 2010
September 26, 2012
October 2009
March 2012   (final data collection date for primary outcome measure)
Health related self-efficacy [ Time Frame: 8 months ] [ Designated as safety issue: No ]
The primary aim of the study will be to develop and test the effect of a texting intervention TAHLC on health-related self-efficacy and frequency of adolescent-conducted healthcare interactions over the study period of 8 months.
Same as current
Complete list of historical versions of study NCT01253733 on ClinicalTrials.gov Archive Site
  • Health knowledge [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Disease health knowledge
  • Health literacy [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Health literacy
  • Quality of Life [ Time Frame: 8 Months ] [ Designated as safety issue: No ]
    Quality of life including depression, self-esteem, and social support will be assessed.
Same as current
Not Provided
Not Provided
 
MD2Me - Texting to Promote Chronic Disease Management
TAHLC - Texting to Promote Adolescent Health Liaisons and Chronic Disease Management

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Cystic Fibrosis
  • Inflammatory Bowel Disease
  • Type 1 Diabetes
  • Chronic Disease Management
Behavioral: MD2ME
The goals of the MD2Me intervention include increasing disease self-efficacy, disease knowledge, and the ability to control one's disease independently. The intervention includes an 8-week web program with weekly behavioral skills, topics on how to navigate the healthcare system, lifestyle tips, a Discussion Board, and text messages.
  • Experimental: SMS and Internet
    The SMS and Internet group will receive information, tips, strategies, and questions related to the self management of chronic disease (cystic fibrosis, inflammatory bowel disease, or type 1 diabetes) on a web-based program and via SMS messages.
    Intervention: Behavioral: MD2ME
  • No Intervention: Control
    The Control group will receive monthly tip sheets on various health topics for adolescents and young adults.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
14 Years to 22 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01253733
091146
Yes
Huang, Jeannie, M.D.
Huang, Jeannie, M.D.
University of California, San Diego
Principal Investigator: Jeannie Huang, MD, MPH University of California, San Diego
Huang, Jeannie, M.D.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP