Asthma Controller Adherence After Hospitalization

NCT ID: NCT02615743

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-10-31

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.

Detailed Description

Poor adherence to inhaled controller medications for asthma is a well-documented and poorly understood problem with a disproportionate prevalence and impact on urban minority children. Recent randomized trials from other countries using electronic monitoring of inhaled steroids with automated adherence feedback demonstrated dramatic improvements in adherence behavior. Whether similar intervention effects can be expected in high-risk children in the US is unknown.

To accomplish the above objectives, investigators propose to enroll 40 children and their parents (20 parent/child dyads in each arm) in a two-month pilot randomized controlled trial of an automated adherence feedback intervention. Children will be from West Philadelphia, ages 4-11, and must be hospitalized for asthma at The Children's Hospital of Philadelphia (CHOP).

The study intervention will include daily automated medication reminders via text messaging for those subjects randomized to the intervention group. Inhaled controller medication adherence will be measured in both groups using electronic monitors affixed to the top of the canister of the inhaled steroid medication and adherence trajectories will be determined using group-based trajectory modeling. Factors associated with adherence trajectories will be assessed using a survey completed upon enrollment, completion of the treatment phase (1 month) and upon completion of follow up (2 months). Feasibility outcomes will include use, acceptance, and preferences. Limited efficacy outcomes will include change in parent-reported asthma control and difference in average percent adherence between intervention and control conditions.

Findings from this study will provide preliminary data for a larger study evaluating the mechanisms of differential adherence trajectories and the effect of an adherence feedback intervention for different mechanisms of non-adherence.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Daily Text message reminder

Intervention Type: BEHAVIORAL

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.

Inhaled steroid canister monitor

Intervention Type: DEVICE

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.

Control Group

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.

Group Type: OTHER

Inhaled steroid canister monitor

Intervention Type: DEVICE

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.

Interventions

Daily Text message reminder

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 Type: BEHAVIORAL

Inhaled steroid canister monitor

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.

Intervention Type: DEVICE

Other Intervention Names

Propeller Health Bluetooth Low Energy (BLE) Sensor

Eligibility Criteria

Inclusion Criteria

1. Has unlimited text messaging plan

2. 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)

3. Patient receives primary care at one of the three urban CHOP primary care practices (Karabots, South Philadelphia, and Cobbs Creek)

Exclusion Criteria

1. 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

2. Subjects with developmental delays or disabilities

3. Families with active Department of Human Services (DHS) involvement

4. Non-English speaking families

5. Parents/guardians or subjects who the inpatient medical team recommends against approaching for enrollment in a research study

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chen C Kenyon, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28347975 (View on PubMed)

Other Identifiers

15-012092

Identifier Type: -

Identifier Source: org_study_id