NCT02860390

Brief Summary

This is a Comparison Effectiveness Research (CER) study in a population of 13 to 40 year-old individuals with persistent asthma comparing differing levels of texting interventions with each other and with a usual care group. The two texting interventions include 1) texting only the individual with asthma and 2) texting the individual with asthma and an important person in that individual's life such as a parent or spouse. These two texting groups will be compared to a group receiving usual asthma care at Denver Health.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started May 2016

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

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
Last Updated

October 3, 2017

Status Verified

October 1, 2017

Enrollment Period

1.3 years

First QC Date

August 3, 2016

Last Update Submit

October 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mean Asthma Control Test Score

    Six months

Secondary Outcomes (6)

  • Asthma-related utilization - Emergent Care

    Six months

  • Asthma-related utilization - Urgent Care

    Six months

  • Asthma-related utilization - Hospitalization

    Six months

  • Quality of Life

    Six months

  • Medication Adherence

    Six months

  • +1 more secondary outcomes

Study Arms (5)

Adolescent - Control

NO INTERVENTION

Usual care arm of subjects aged 13-19 years old

Adolescent - SMS

EXPERIMENTAL

Subjects aged 13-19 years and receiving Denver Health Asthma Management Program (text messaging intervention)

Other: Denver Health Asthma Management Program

Adolescent - SMS plus support person

EXPERIMENTAL

Subjects aged 13-19 years, Denver Health Asthma Management Program (text messaging intervention) sent to subjects and subjects' chosen Person of Support.

Other: Denver Health Asthma Management ProgramOther: Person of Support

Adult - Control

NO INTERVENTION

Usual care arm of subjects aged 20-40 years old.

Adult - SMS

EXPERIMENTAL

Subjects aged 20-40 years and receiving Denver Health Asthma Management Program (text messaging intervention).

Other: Denver Health Asthma Management Program

Interventions

text message (SMS) support including educational, motivational, and resource content.

Adolescent - SMSAdolescent - SMS plus support personAdult - SMS

Subjects in the adolescent cohort will designate a support person (e.g. parent) to receive messages from the Denver Health Asthma Management Program

Adolescent - SMS plus support person

Eligibility Criteria

Age13 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subject and significant other as applicable must have phone or other device capable of receiving text messages
  • Ages 13 to 19 with persistent asthma per Denver Health electronic health record and/or HEDIS (modified) criteria for asthma
  • Ages 20 to 40 with HEDIS (modified) criteria for persistent asthma
  • Hospital-based utilization for asthma (i.e. persistent asthma)
  • Denver Health Primary Care Provider visits within last 3 years
  • Ability to read English or Spanish.

You may not qualify if:

  • complex and special health care needs pediatric patients
  • pregnant/expectant mothers
  • incarcerated individuals
  • Non-English and non-Spanish speakers
  • Patients who by input of the primary care provider are less likely to participate in an interactive asthma text messaging trial (e.g. intellectual delay, mental health issues)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

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

August 3, 2016

First Posted

August 9, 2016

Study Start

May 1, 2016

Primary Completion

August 15, 2017

Study Completion

August 15, 2017

Last Updated

October 3, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share