NCT01253733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

2.4 years

First QC Date

November 30, 2010

Last Update Submit

January 25, 2016

Conditions

Cystic FibrosisInflammatory Bowel DiseaseType 1 DiabetesChronic Disease Management

Keywords

Cystic FibrosisInflammatory Bowel DiseaseType 1 DiabetesChronic Disease ManagementSMSText messagesInternetHealthcare Interactions

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 months

Secondary Outcomes (3)

  • Health knowledge

    8 months

  • Health literacy

    8 months

  • Quality of Life

    8 Months

Study Arms (2)

SMS and Internet

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

MD2MEBEHAVIORAL

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.

SMS and Internet

Eligibility Criteria

Age14 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Related Publications (1)

  • 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.

    PMID: 24843066BACKGROUND

MeSH Terms

Conditions

Cystic FibrosisInflammatory Bowel DiseasesDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jeannie Huang, MD, MPH

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 3, 2010

Study Start

October 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

January 26, 2016

Record last verified: 2016-01

Locations

US(1)