Denver Health Asthma Management Program

Asthma Clinical Trial

— DHAMP  

Official title:

Denver Health Asthma Management Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02860390
• Other study ID #: 15-0308 (Anderson)
• Status: Completed
• Phase: N/A
• First received: August 3, 2016
• Last updated: October 2, 2017
• Start date: May 2016
• Est. completion date: August 15, 2017

Study information

• Verified date: October 2017
• Source: Denver Health and Hospital Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 15, 2017
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 40 Years

Eligibility

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 ß-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)

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Denver Health Asthma Management Program
text message (SMS) support including educational, motivational, and resource content.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Denver Health and Hospital Authority	University of Colorado, Denver

Outcome

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