Technology Enabled Asthma Management System (TEAMS) Pilot Study

Uncontrolled asthma is a tremendous burden to individuals and society. Asthma is one of the
most common chronic health conditions globally, affecting more than 8.2% of adults in the
U.S. Of adults with asthma in the U.S., 63% have persistent disease, and less than half are
well-controlled. Uncontrolled asthma is associated with bothersome symptoms, economic burden,
lost work time, and poorer quality of life. Direct and indirect costs are estimated at 56
billion dollars annually, with over 1.8 million ED visits, 439,000 hospitalizations, and
3,400 deaths in 2010 alone. Asthma morbidity and mortality is preventable. Correct use of
controller medication and effective self-management alleviates symptoms, prevents
exacerbations, and minimizes long-term damage to lungs associated with pulmonary remodeling.
For these reasons, the National Heart Lung & Blood Institute (NHLBI) Guidelines recommend
that all individuals with persistent asthma should take daily controller medications and
receive consistent self-management training.

Currently, less than half of adults with persistent asthma take controller medication, and
most do not self-manage their asthma effectively. Patient, provider, and systems-level
factors contribute to this pattern. Patients fail to report symptoms, take medications
inconsistently, and have insufficient resources (knowledge, time, transportation, money) to
manage their disease.Providers in turn may lack familiarity with current best-practice
guidelines, follow alternate prescribing practices, or spend insufficient time educating
patients. Translation of asthma management knowledge into practice-based solutions is
urgently needed. Many asthma interventions have been implemented within
investigator-controlled settings. Problematically, few have been evaluated within or
translated into the context of real world practice, and thus hold little benefit for the
greater patient population. Limited ability to translate interventions from the bench to
clinical settings suggests a need to develop and test interventions within the context in
which they are intended to function. Effective real-world intervention to improve asthma
outcomes requires development of a multifaceted program targeting key factors at the patient,
provider, and systems level.

These include:

- Patient tendency to ignore, forget, and not report symptoms;

- Patient non-adherence to prescribed medication;

- Patient lack of self-management skills and knowledge on how to self-manage effectively;

- Barriers to consistent follow-up (access to care, burdens of time and transportation);

- Provider non-adherence to National Guidelines for step-wise management of asthma; and

- Provider underestimation of symptoms, and lack of time to provide thorough asthma
education.

Therefore, the purpose of this study is to test feasibility, acceptability, safety, and
preliminary efficacy of comprehensive Technology Enabled Asthma Management System (TEAMS),
which addresses these critical factors, in order to improve asthma management and outcomes in
younger adults.

The specific aims of the study are:

Aim 1: To evaluate feasibility and acceptability of TEAMS. • Hypothesis A: TEAMS will be
feasible for and acceptable to young adults and primary care providers for routine management
of asthma, as measured by USE-Q survey data, frequency of symptom self-monitoring and at
completion of least one virtual visit, and post-intervention qualitative interviews.

Aim 2: To evaluate safety and preliminary efficacy of TEAMS.

• Hypothesis B: TEAMS will be associated with improved asthma outcomes following
intervention, as measured by primary outcomes of: (a) increased asthma control, pulmonary
function, quality of life, and secondary outcomes of (b) decreased office visits for asthma
exacerbations, asthma-related ED visits, and hospitalizations.

Aim 3: To optimize TEAMS intervention components based on quantitative survey data and
qualitative interviews, including patient subject and clinic staff perspectives.

2. STUDY DESIGN

2.1. Overview TEAMS is a multi-level, theoretically-based intervention that capitalizes on
patient—provider—nurse partnerships and use of technology to improve the quality and
convenience of routine asthma care. TEAMS has Social Cognitive Theory underpinnings. It
targets person level factors associated with asthma outcomes (individual knowledge, norms,
attitudes, illness beliefs and self-efficacy), self-management behaviors (prevention,
monitoring, management and communication of symptoms), and environmental factors (access to
care, delivery of guideline-based care).

The overarching goal of TEAMS is to improve asthma outcomes by leveraging capabilities of
existing technology (smartphone, telemedicine, electronic medical record). TEAMS will operate
in conjunction with standard care in the Medicine Clinic.

Inclusion Criteria:

Patient Subjects:

- Target population, Age 18-40; Age criteria may be expanded to include adults older
than 40 as needed to meet recruitment needs

- With a diagnosis of intermittent or persistent asthma;

- Possessing an active smartphone with data plan or WiFi access;

- Able to communicate in English.

- Able to perform study-related functions

- Able to give informed consent.

(All patient subjects will be counseled that telemedicine visits consume large amounts of
data, and that use of Wifi is recommended. Patient subjects will be required to initial
acknowledgement of this in the consent form. Currently however, many people have unlimited
data plans, which may allow visits away from Wifi.)

Provider Subjects:

• Primary care provider to patient subjects enrolled in the study

Other Staff Subjects:

• Secretarial or Nursing staff at the clinic, having interaction with patient subjects or
procedures.

Exclusion Criteria:

Patient Subjects:

- Diagnosis of confounding respiratory or cardiac diseases (e.g. cystic fibrosis,
sarcoidosis, COPD, CHF, Hypertension);

- Pregnancy

Provider Subjects:

• None

Other Staff Subjects:

• None