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MD2Me - Texting to Promote Chronic Disease Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01253733
First Posted: December 3, 2010
Last Update Posted: January 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
Huang, Jeannie, M.D.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    Disease health knowledge

  • Health literacy [ Time Frame: 8 months ]
    Health literacy

  • Quality of Life [ Time Frame: 8 Months ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Huang, Jeannie, M.D.
ClinicalTrials.gov Identifier: NCT01253733     History of Changes
Other Study ID Numbers: 091146
First Submitted: November 30, 2010
First Posted: December 3, 2010
Last Update Posted: January 26, 2016
Last Verified: January 2016

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