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Denver Health Asthma Management Program (DHAMP)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Denver Health Asthma Management Program
Person of Support
Sponsored by
Denver Health and Hospital Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma

Eligibility Criteria

13 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    No Intervention

    Experimental

    Experimental

    No Intervention

    Experimental

    Arm Label

    Adolescent - Control

    Adolescent - SMS

    Adolescent - SMS plus support person

    Adult - Control

    Adult - SMS

    Arm Description

    Usual care arm of subjects aged 13-19 years old

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Mean Asthma Control Test Score

    Secondary Outcome Measures

    Asthma-related utilization - Emergent Care
    Emergent care
    Asthma-related utilization - Urgent Care
    Urgent Care
    Asthma-related utilization - Hospitalization
    Hospitalizations
    Quality of Life
    as measured by the Juniper Asthma Quality of Life Questionnaire(s) and PHQ-4
    Medication Adherence
    as measured by the Asthma Medication Ratio
    Pre/Post Comparison of Asthma Control Test score

    Full Information

    First Posted
    August 3, 2016
    Last Updated
    October 2, 2017
    Sponsor
    Denver Health and Hospital Authority
    Collaborators
    University of Colorado, Denver
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02860390
    Brief Title
    Denver Health Asthma Management Program
    Acronym
    DHAMP
    Official Title
    Denver Health Asthma Management Program
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    August 15, 2017 (Actual)
    Study Completion Date
    August 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Denver Health and Hospital Authority
    Collaborators
    University of Colorado, Denver

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    154 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Adolescent - Control
    Arm Type
    No Intervention
    Arm Description
    Usual care arm of subjects aged 13-19 years old
    Arm Title
    Adolescent - SMS
    Arm Type
    Experimental
    Arm Description
    Subjects aged 13-19 years and receiving Denver Health Asthma Management Program (text messaging intervention)
    Arm Title
    Adolescent - SMS plus support person
    Arm Type
    Experimental
    Arm Description
    Subjects aged 13-19 years, Denver Health Asthma Management Program (text messaging intervention) sent to subjects and subjects' chosen Person of Support.
    Arm Title
    Adult - Control
    Arm Type
    No Intervention
    Arm Description
    Usual care arm of subjects aged 20-40 years old.
    Arm Title
    Adult - SMS
    Arm Type
    Experimental
    Arm Description
    Subjects aged 20-40 years and receiving Denver Health Asthma Management Program (text messaging intervention).
    Intervention Type
    Other
    Intervention Name(s)
    Denver Health Asthma Management Program
    Intervention Description
    text message (SMS) support including educational, motivational, and resource content.
    Intervention Type
    Other
    Intervention Name(s)
    Person of Support
    Intervention Description
    Subjects in the adolescent cohort will designate a support person (e.g. parent) to receive messages from the Denver Health Asthma Management Program
    Primary Outcome Measure Information:
    Title
    Mean Asthma Control Test Score
    Time Frame
    Six months
    Secondary Outcome Measure Information:
    Title
    Asthma-related utilization - Emergent Care
    Description
    Emergent care
    Time Frame
    Six months
    Title
    Asthma-related utilization - Urgent Care
    Description
    Urgent Care
    Time Frame
    Six months
    Title
    Asthma-related utilization - Hospitalization
    Description
    Hospitalizations
    Time Frame
    Six months
    Title
    Quality of Life
    Description
    as measured by the Juniper Asthma Quality of Life Questionnaire(s) and PHQ-4
    Time Frame
    Six months
    Title
    Medication Adherence
    Description
    as measured by the Asthma Medication Ratio
    Time Frame
    Six months
    Title
    Pre/Post Comparison of Asthma Control Test score
    Time Frame
    Six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Denver Health Asthma Management Program

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