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Completed

NCT Number: NCT02860390

Denver Health Asthma Management Program

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.

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Key information

Age range

13 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This is Phase 2 of a two-phase pilot project to build and study a texting program for patients at Denver Health who have persistent asthma. The overall goal of the program is to provide educational support for asthma care between clinic visits and to survey for evidence of poorly controlled asthma, which would prompt clinic recall. Phase 1 used a focus group/interview methodology to inform Phase 2 and allow Phase 2 to be more patient-centered. Based on results of focus groups/interviews, the investigators will conduct a three-arm trial among 13- to 19-year-olds and a two-arm trial among 20- to 40-year-olds. For the 13- to 19-year-old group, a 'usual care' group will be compared to two intervention groups: 1) a subject group receiving text messages about asthma care and 2) a group of subjects and their 'significant other', such as a parent, who will also receive the text messages. Overall, Phase 1 findings suggested the 20- to 40-year-old group was more reluctant to involve a significant other and therefore for this group a 'usual care' arm will be compared to an arm where only the patient receives the text messages, but not a significant other. Other features built into Phase 2 upon recommendation from the focus group/interview phase include a midpoint survey and tailoring the amount of texting a patient receives based on the level of asthma control elicited by administration of the validated tool, the Asthma Control Test (ACT).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • complex and special health care needs pediatric patients
  • pregnant/expectant mothers
  • incarcerated individuals
  • Non-English and non-Spanish speakers
  • Chronic Obstructive Pulmonary Disease/COPD or other non-asthma pulmonary diagnoses (e.g. pulmonary function testing inconsistent with asthma and/or negative methacholine challenge testing/lack of reversibility with β-agonist, diagnostic errors despite inclusion in the Asthma Registry)
  • 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)

Treatment and study plan

Denver Health Asthma Management Program

Other

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

Person of Support

Other

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

Primary outcomes

  1. Mean Asthma Control Test Score

    Time frame: Six months

Secondary outcomes

  1. Asthma-related utilization - Emergent Care

    Time frame: Six months

    Emergent care

  2. Asthma-related utilization - Urgent Care

    Time frame: Six months

    Urgent Care

  3. Asthma-related utilization - Hospitalization

    Time frame: Six months

    Hospitalizations

  4. Quality of Life

    Time frame: Six months

    as measured by the Juniper Asthma Quality of Life Questionnaire(s) and PHQ-4

  5. Medication Adherence

    Time frame: Six months

    as measured by the Asthma Medication Ratio

  6. Pre/Post Comparison of Asthma Control Test score

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

Denver Health and Hospital Authority

Other

Collaborators

  • University of Colorado, Denver

Registry information

Acronym: DHAMP

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 9, 2016
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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