AsthmamymedihealthNCT01730235
My MediHealth: A Paradigm for Children-centered Medication Management
An observational study of Asthma, run by Vanderbilt University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- MyMediHealth access
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Oct 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children and adolescents between the ages of 12 and 17 with a diagnosis of asthma and on at least one daily medication.
Who may be able to join
- 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
Who cannot join
- non English or spanish speaking family
Trial locations and contacts
1 site in 1 country.
United States1 site
Vandebilt Monroe Carell Children's Hospital
Nashville, Tennessee, 37232
About this study
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.
- Conditions
- Asthma
- Being tested
- MyMediHealth access
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyMediHealth accessOther
Patients who will be given access to a web-based medication scheduling and SMS-based reminder system.
| Study group | Role | What they receive |
|---|---|---|
| Case Group | Group receiving access to MyMediHealth web site. | |
| Control Group | Children completing baseline and week two measures, but without any additional intervention. Receives: Other: MyMediHealth access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline asthma self efficacy after 3 weeks
Will assess self-efficacy using the survey by Bursch and colleagues (1997)
Measured: 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.
Secondary outcomes (1)
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.
Measured: Participants will be followed for 4 weeks, with measurements at baseline and the end of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Johnson, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730235
- Sponsor's protocol ID
- R18HS018168
- Acronym
- mymedihealth
- Status last verified
- Nov 2012
- First submitted
- 8 Nov 2012
- Last updated
- 21 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnson KB, Patterson BL, Ho YX, Chen Q, Nian H, Davison CL, Slagle J, Mulvaney SA. The feasibility of text reminders to improve medication adherence in adolescents with asthma. J Am Med Inform Assoc. 2016 May;23(3):449-55. doi: 10.1093/jamia/ocv158. Epub 2015 Dec 11.
PubMed 26661717
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- My MediHealth: A Paradigm for Children-centered Medication Management
- ClinicalTrials.gov ID
- NCT01730235
- Acronym / sponsor ID
- mymedihealth / R18HS018168
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- First posted
- 21 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group | – | –Group receiving access to MyMediHealth web site. |
| Control Group | – | Other: MyMediHealth accessChildren completing baseline and week two measures, but without any additional intervention. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children and adolescents between the ages of 12 and 17 with a diagnosis of asthma and on at least one daily medication.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- non English or spanish speaking family
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyMediHealth accessPatients who will be given access to a web-based medication scheduling and SMS-based reminder system. | Other | Control Group |
Primary outcome
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.
Will assess self-efficacy using the survey by Bursch and colleagues (1997)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2012.
- Derived from this study: PubMed 26661717Johnson KB, Patterson BL, Ho YX, Chen Q, Nian H, Davison CL, Slagle J, Mulvaney SA. The feasibility of text reminders to improve medication adherence in adolescents with asthma. J Am Med Inform Assoc. 2016 May;23(3):449-55. doi: 10.1093/jamia/ocv158. Epub 2015 Dec 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01730235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2012.