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MD2Me - Texting to Promote Chronic Disease Management

Primary Purpose

Cystic Fibrosis, Inflammatory Bowel Disease, Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MD2ME
Sponsored by
Huang, Jeannie, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Inflammatory Bowel Disease, Type 1 Diabetes, Chronic Disease Management, SMS, Text messages, Internet, Healthcare Interactions

Eligibility Criteria

14 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

SMS and Internet

Control

Arm Description

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.

The Control group will receive monthly tip sheets on various health topics for adolescents and young adults.

Outcomes

Primary Outcome Measures

Health related self-efficacy
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
Disease health knowledge
Health literacy
Health literacy
Quality of Life
Quality of life including depression, self-esteem, and social support will be assessed.

Full Information

First Posted
November 30, 2010
Last Updated
January 25, 2016
Sponsor
Huang, Jeannie, M.D.
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01253733
Brief Title
MD2Me - Texting to Promote Chronic Disease Management
Official Title
TAHLC - Texting to Promote Adolescent Health Liaisons and Chronic Disease Management
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Huang, Jeannie, M.D.
Collaborators
University of California, San Diego

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMS and Internet
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The Control group will receive monthly tip sheets on various health topics for adolescents and young adults.
Intervention Type
Behavioral
Intervention Name(s)
MD2ME
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health related self-efficacy
Description
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.
Time Frame
8 months
Secondary Outcome Measure Information:
Title
Health knowledge
Description
Disease health knowledge
Time Frame
8 months
Title
Health literacy
Description
Health literacy
Time Frame
8 months
Title
Quality of Life
Description
Quality of life including depression, self-esteem, and social support will be assessed.
Time Frame
8 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannie Huang, MD, MPH
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24843066
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.
Results Reference
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MD2Me - Texting to Promote Chronic Disease Management

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