My MediHealth: A Paradigm for Children-centered Medication Management

Asthma Clinical Trial

— mymedihealth  

Official title:

My MediHealth: A Paradigm for Children-centered Medication Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730235
• Other study ID #: R18HS018168
• Status: Completed
• Phase: N/A
• First received: November 8, 2012
• Last updated: November 14, 2012
• Start date: May 2012

Study information

• Verified date: November 2012
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• MyMediHealth access
Patients who will be given access to a web-based medication scheduling and SMS-based reminder system.

Locations

Country	Name	City	State
United States	Vandebilt Monroe Carell Children's Hospital	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in baseline asthma self efficacy after 3 weeks	Will assess self-efficacy using the survey by Bursch and colleagues (1997)	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.	No
Secondary	Change in medication adherence after 3 weeks	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.	Participants will be followed for 4 weeks, with measurements at baseline and the end of 3 weeks	Yes