Denver Health Asthma Management Program (DHAMP)

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Other: Denver Health Asthma Management Program; Other: Person of Support

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).

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Adolescent - Control; Usual care arm of subjects aged 13-19 years old
Experimental: Adolescent - SMS; Subjects aged 13-19 years and receiving Denver Health Asthma Management Program (text messaging intervention)	Other: Denver Health Asthma Management Program; text message (SMS) support including educational, motivational, and resource content.
Experimental: Adolescent - SMS plus support person; 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 Program; text message (SMS) support including educational, motivational, and resource content.; Other: Person of Support; Subjects in the adolescent cohort will designate a support person (e.g. parent) to receive messages from the Denver Health Asthma Management Program
No Intervention: Adult - Control; Usual care arm of subjects aged 20-40 years old.
Experimental: Adult - SMS; Subjects aged 20-40 years and receiving Denver Health Asthma Management Program (text messaging intervention).	Other: Denver Health Asthma Management Program; text message (SMS) support including educational, motivational, and resource content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean Asthma Control Test Score	Six months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Denver Health and Hospital Authority
• Collaborators: University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): August 15, 2017
• Study Completion (Actual): August 15, 2017

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 8, 2016
• First Posted (Estimate): August 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 15-0308 (Anderson)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No