NCT03515499

Brief Summary

Financial incentives have been suggested as a possible means for increasing adherence to asthma medications. This study will evaluate an incentive strategy (daily small reward for adherence) in maintaining high levels of adherence as tracked by adherence sensors in adolescents with asthma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Jul 2018

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

February 5, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

July 6, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2020

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

1.6 years

First QC Date

February 5, 2018

Last Update Submit

June 9, 2020

Conditions

AsthmaAsthma in Children

Keywords

AdherenceIncentives

Outcome Measures

Primary Outcomes (1)

  • Change in adherence rates

    This Outcome will measure the difference in adherence at the end of the study period between the 2 groups as measured by the adherence devices (calculated as percent adherence per week over the 12 week study period).

    Daily for 12 weeks

Secondary Outcomes (3)

  • Changes in Qualitative outcomes - Barriers

    After 3 months of monitoring

  • Changes in Qualitative outcomes - Facilitators

    After 3 months of monitoring

  • Changes in Qualitative outcomes - Incentives

    After 3 months of monitoring

Study Arms (2)

Control

ACTIVE COMPARATOR

The control arm will have medication monitoring sensors placed on their asthma medications. They will have reminders to take their medicines and access to a mobile app that will show them trends in their medication use.

Behavioral: Medication device monitoring and reminders

Treatment arm

EXPERIMENTAL

The treatment arm will have medication monitoring sensors placed on their asthma medications. They will have reminders to take their medicines and access to a mobile app that will show them trends in their medication use. Additionally, they will be paid up to $1 per day for perfect medication adherence.

Behavioral: IncentivesBehavioral: Medication device monitoring and reminders

Interventions

IncentivesBEHAVIORAL

Subjects in the treatment arm will be paid up to $1 per day over 3 months for perfect medication adherence. Adherence rates will then be compared between the 2 groups.

Treatment arm
Medication device monitoring and remindersBEHAVIORAL

Bluetooth enabled sensor device for medication reminders, as well as mobile app to track medication use.

ControlTreatment arm

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • physician diagnosed asthma
  • on at least one inhaled controller medication

You may not qualify if:

  • language other than English or Spanish (these are the only languages supported by the adherence monitoring application)
  • other severe chronic lung disease including tracheostomy/ventilator dependence, interstitial lung disease or cystic fibrosis, or significant developmental delay.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

  • Keyser HH, Brinton JT, Bothwell S, Camacho M, Kempe A, Szefler SJ. Encouraging adherence in adolescents with asthma using financial incentives: An RCT. Pediatr Pulmonol. 2023 Oct;58(10):2823-2831. doi: 10.1002/ppul.26594. Epub 2023 Jul 14.

    PMID: 37449768DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Fertility

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Heather Hoch, MD

    Assistant Professor

    PRINCIPAL INVESTIGATOR

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

February 5, 2018

First Posted

May 3, 2018

Study Start

July 6, 2018

Primary Completion

February 5, 2020

Study Completion

February 5, 2020

Last Updated

June 11, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

No IPD will be shared with other researchers

Locations

US(1)