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
  Purpose

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.


Condition Intervention
Asthma
Other: MyMediHealth access

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: My MediHealth: A Paradigm for Children-centered Medication Management

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Enrollment: 115
Study Start Date: May 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Case Group
Group receiving access to MyMediHealth web site.
Control Group
Children completing baseline and week two measures, but without any additional intervention.
Other: MyMediHealth access
Patients who will be given access to a web-based medication scheduling and SMS-based reminder system.

  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730235

Locations
United States, Tennessee
Vandebilt Monroe Carell Children's Hospital
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Kevin Johnson, Professor and Chair, Biomedical Informatics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01730235     History of Changes
Other Study ID Numbers: R18HS018168
Study First Received: November 8, 2012
Last Updated: November 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 27, 2014