Denver Health Asthma Management Program

NCT ID: NCT02860390

Last Updated: 2017-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-08-15

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).

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Adolescent - Control

Usual care arm of subjects aged 13-19 years old

Group Type: NO_INTERVENTION

No interventions assigned to this group

Adolescent - SMS

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

Group Type: EXPERIMENTAL

Denver Health Asthma Management Program

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Denver Health Asthma Management Program

Intervention Type: OTHER

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

Person of Support

Intervention Type: OTHER

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

Adult - Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Adult - SMS

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

Group Type: EXPERIMENTAL

Denver Health Asthma Management Program

Intervention Type: OTHER

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

Interventions

Denver Health Asthma Management Program

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

Intervention Type: 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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Denver Health and Hospital Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

15-0308 (Anderson)

Identifier Type: -

Identifier Source: org_study_id