Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 8, 2012
November 14, 2012
May 2012
October 2012   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01730235 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
My MediHealth: A Paradigm for Children-centered Medication Management
My MediHealth: A Paradigm for Children-centered Medication Management

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Children and adolescents between the ages of 12 and 17 with a diagnosis of asthma and on at least one daily medication.

Asthma
Other: MyMediHealth access
Patients who will be given access to a web-based medication scheduling and SMS-based reminder system.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
Not Provided
October 2012   (final data collection date for primary outcome measure)

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
Both
12 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01730235
R18HS018168
No
Kevin Johnson, Vanderbilt University
Vanderbilt University
Not Provided
Not Provided
Vanderbilt University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP