My MediHealth: A Paradigm for Children-centered Medication Management (mymedihealth)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kevin Johnson, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01730235

First received: November 8, 2012

Last updated: November 14, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	November 8, 2012
Last Updated Date	November 14, 2012
Start Date ^ICMJE	May 2012
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 14, 2012)	Change in baseline asthma self efficacy after 3 weeks [ Time Frame: participants will be followed for an average of 4 weeks, with this measure collect at the beginning of the period and after 3 weeks of reminders. ] [ Designated as safety issue: No ] Will assess self-efficacy using the survey by Bursch and colleagues (1997)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01730235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 14, 2012)	Change in medication adherence after 3 weeks [ Time Frame: Participants will be followed for 4 weeks, with measurements at baseline and the end of 3 weeks ] [ Designated as safety issue: Yes ] At the end of the 2-week data collection period (following the 1-week test period), all participants (Control and Intervention) and their parents will be asked to complete a brief online survey, including the Asthma Control Test (ACT) and the weekly adherence survey(SDSCA). All responses collected from participants and their parents in the Time 2 Survey will be compared to those collected from the Baseline Survey, where applicable. Medication adherence will be measured by responses to ACT and SDSCA survey items for all participants.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	My MediHealth: A Paradigm for Children-centered Medication Management
Official Title ^ICMJE	My MediHealth: A Paradigm for Children-centered Medication Management
Brief Summary	The last mile of the medication use system requires tools to help patients comply with medication administration rules and monitor for side effects. Personal health records (PHR) and emerging user-adopted communication tools promise to change the landscape of medication management. The overarching goal of the MyMediHealth project is to investigate ways in which PHRs and supported applications can improve the safety and quality of medication delivery. Preliminary work in this area by a team of parents, patients and school/clinic health providers created a vision for MyMediHealth, a next-generation medication management system. MyMediHealth was envisioned to allow home-based, school-based, and other caregivers to ensure safe and effective medication delivery. This vision featured just-in-time medication reminders to children with special health care needs, two-way communication to log when doses have been administered or when side effects have occurred, and mechanisms to warn caregivers about side effects and drug interactions. However, much of this work was done using prototypes, storyboards, and vision videos. Recognizing that this vision cannot be carried out without significant changes in processes and policies, the purpose of this proposed study is to evaluate the impact of medication management tools such as MyMediHealth on medication adherence for children with chronic illnesses. Specifically, the investigators hypothesize that compared with usual practice, children using mymedihealth will have improved medication adherence and will report improved (decreased) asthma symptoms.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Children and adolescents between the ages of 12 and 17 with a diagnosis of asthma and on at least one daily medication.
Condition ^ICMJE	Asthma
Intervention ^ICMJE	Other: MyMediHealth access Patients who will be given access to a web-based medication scheduling and SMS-based reminder system.
Study Group/Cohort (s)	Case Group Group receiving access to MyMediHealth web site. Control Group Children completing baseline and week two measures, but without any additional intervention. Intervention: Other: MyMediHealth access
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	115
Completion Date	Not Provided
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Access to the internet Caregiver agrees to let child use the Internet for the project Internet service working properly Legal guardian approves of study Child with her or his own cell phone Exclusion Criteria: non English or spanish speaking family
Gender	Both
Ages	12 Years to 17 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01730235
Other Study ID Numbers ^ICMJE	R18HS018168
Has Data Monitoring Committee	No
Responsible Party	Kevin Johnson, Vanderbilt University
Study Sponsor ^ICMJE	Vanderbilt University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Vanderbilt University
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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