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
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Inflammatory Bowel Disease
Type 1 Diabetes
Chronic Disease Management
Behavioral: MD2ME

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: TAHLC - Texting to Promote Adolescent Health Liaisons and Chronic Disease Management

Resource links provided by NLM:


Further study details as provided by Huang, Jeannie, M.D.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 81
Study Start Date: October 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
No Intervention: Control
The Control group will receive monthly tip sheets on various health topics for adolescents and young adults.

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

Ages Eligible for Study:   14 Years to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253733

Locations
United States, California
University of California, San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
Huang, Jeannie, M.D.
University of California, San Diego
Investigators
Principal Investigator: Jeannie Huang, MD, MPH University of California, San Diego
  More Information

No publications provided by Huang, Jeannie, M.D.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Huang, Jeannie, M.D.
ClinicalTrials.gov Identifier: NCT01253733     History of Changes
Other Study ID Numbers: 091146
Study First Received: November 30, 2010
Last Updated: September 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Huang, Jeannie, M.D.:
Cystic Fibrosis
Inflammatory Bowel Disease
Type 1 Diabetes
Chronic Disease Management
SMS
Text messages
Internet
Healthcare Interactions

Additional relevant MeSH terms:
Chronic Disease
Cystic Fibrosis
Diabetes Mellitus
Diabetes Mellitus, Type 1
Fibrosis
Inflammatory Bowel Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Gastroenteritis
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 22, 2014