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

About this trial
This is an interventional health services research trial for Asthma
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)
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
NCT ID
NCT02860390
First Posted
August 3, 2016
Last Updated
October 2, 2017
Sponsor
Denver Health and Hospital Authority
Collaborators
University of Colorado, Denver
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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