NCT02615743

Brief Summary

This study sets out to assess whether daily text message reminders help to enhance the consistency of use of controller medications following hospitalization for pediatric asthma patients ages 4-11 and their families. Text message reminders will be delivered to a subject's cell phone for those in the intervention group and electronic monitors will placed on the controller inhalers at the time of hospital discharge to track medication use over time in both the intervention and the regular care group. Families will complete surveys on the day of enrollment (in person), day 30 (telephone) and day 60 (telephone) on aspects of asthma care including asthma knowledge, medication routines, who is responsible for asthma care, and medication beliefs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2016

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 31, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

November 23, 2015

Results QC Date

September 20, 2017

Last Update Submit

April 8, 2019

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

  • Comparison of Number and Percentage of Patients That Use Monitoring Device Over 30 Days (Feasibility)

    The number and percentage of patients that continue to use the monitoring device throughout the month will be compared between the intervention and control groups.

    30 days

  • Acceptability

    The rating of the monitoring device will be compared between groups based on responses to a questionnaire asking about acceptability and preferences to determine if there is a difference in the "favorability" We determined this by the number of participants who found text message reminders helpful to avoid missing doses. After 30 days caregivers of control group participants were given the option to receive daily text messages; they were asked about acceptability 30 days later.

    30 days (intervention group) 60 days (control group)

Secondary Outcomes (2)

  • Adherence

    30 days

  • Change in Child Asthma Control Tool Score (cACT) From Baseline to End of Intervention Period.

    30 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

Caregivers of intervention arm participants will receive daily text message reminders about asthma controller medication use, as well as an electronic monitoring device to track the participant's medication usage for 60 days following hospital discharge. At the end of 30 days, participants will be able to opt out of daily text messages if they choose. All caregivers of participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.

Behavioral: Daily Text message reminderDevice: Inhaled steroid canister monitor

Control Group

OTHER

Caregivers of control arm participants will receive an electronic monitoring device to track their medication usage for 60 days following hospital discharge. At 30 days, caregivers of participants will be able to opt in to receive daily text message reminders about asthma medication use. Caregivers of all participants will also complete a 30-minute survey at the time of enrollment and 2 brief telephone followups at 30 and 60 days.

Device: Inhaled steroid canister monitor

Interventions

Daily Text message reminderBEHAVIORAL

Subjects in the intervention arm will receive once daily text messages at the time of their choice or at a default time of 7am. The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.

Intervention Group
Inhaled steroid canister monitorDEVICE

An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem. Data is then sent via the cellular network to the secure Propeller server. The data will then be downloaded monthly.

Also known as: Propeller Health Bluetooth Low Energy (BLE) Sensor
Control GroupIntervention Group

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Has unlimited text messaging plan
  • Prescribed one of the following metered dose inhalers for daily use: Flovent (fluticasone), QVAR (budesonide), Seretide (fluticasone-salmeterol), Advair multi-dose inhaler (MDI) (fluticasone-salmeterol) or Dulera (mometasone-formoterol)
  • Patient receives primary care at one of the three urban CHOP primary care practices (Karabots, South Philadelphia, and Cobbs Creek)

You may not qualify if:

  • Subjects prescribed a controller medication to which the electronic device cannot affix (i.e. montelukast, Advair Diskus, Symbicort, Seretide Acuhaler/Diskus) as their primary controller medication
  • Subjects with developmental delays or disabilities
  • Families with active Department of Human Services (DHS) involvement
  • Non-English speaking families
  • Parents/guardians or subjects who the inpatient medical team recommends against approaching for enrollment in a research study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Adams SA, Leach MC, Feudtner C, Miller VA, Kenyon CC. Automated Adherence Reminders for High Risk Children With Asthma: A Research Protocol. JMIR Res Protoc. 2017 Mar 27;6(3):e48. doi: 10.2196/resprot.6674.

    PMID: 28347975DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Dr. Chen Kenyon, Faculty PolicyLab and Assistant Professor University of Pennsylvania
Organization
Children's Hospital of Philadelphia
kenyonc@email.chop.edu
267-426-6339

Study Officials

  • Chen C Kenyon, MD, MS

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2015

First Posted

November 26, 2015

Study Start

December 1, 2015

Primary Completion

September 20, 2016

Study Completion

October 1, 2016

Last Updated

April 16, 2019

Results First Posted

January 31, 2018

Record last verified: 2019-04

Locations

US(1)