## Protocol Section
### Identification Module
**NCT ID:** NCT03518879

**Brief Title:** ASTHMA-Educator Mobile Application Manage Asthma

**Official Title:** The ASTHMA-Educator: A Novel Algorithmic Software Tool to Help Manage Asthma

#### Organization Study ID Info
**ID:** 2013-2693
#### Organization
**Class:** OTHER
**Full Name:** Montefiore Medical Center
### Status Module
#### Completion Date
**Date:** 2021-07-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-06-07

**Type:** ACTUAL

**Last Update Submit Date:** 2023-06-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-07-01

**Type:** ACTUAL

#### Start Date
**Date:** 2015-03

**Type:** ACTUAL

**Status Verified Date:** 2023-06

#### Study First Post Date
**Date:** 2018-05-08
**Type:** ACTUAL
**Study First Submit Date:** 2018-04-13
**Study First Submit QC Date:** 2018-04-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Montefiore Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use among adult asthma patients at Montefiore.

**Detailed Description:** Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use through 2 phases: 1) Phase 1 = process outcomes evaluation with 30 patients); and 2) Phase 2 (longitudinal clinical evaluation with 40 patients receiving the intervention at baseline, 2 months, 4 months, and 6 months). The study's primary outcome is asthma control.

### Conditions Module

**Conditions:**

- Asthma

**Keywords:**

- informatics

- asthma

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** This is a single-arm proof of concept study to evaluate the impact of the ASTHMA-Educator on process and clinical outcomes

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 70

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The ASTHMA-Educator mobile application for patient-centered asthma education. The application is administered via on-site iPad (tablet).

**Intervention Names:**

- Other: ASTHMA-Educator mobile application

**Label:** ASTHMA-Educator arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ASTHMA-Educator arm

**Description:** The on-site delivered ASTHMA-Educator mobile application.

**Name:** ASTHMA-Educator mobile application

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Asthma symptom burden as measured by the Asthma Control Test

**Measure:** Change from baseline asthma control to 2, 4, and 6 months

**Time Frame:** Baseline, 2 months, 4 months, 6 months

#### Secondary Outcomes

**Description:** Asthma knowledge as measured by the validated Asthma Knowledge Questionnaire

**Measure:** Change from baseline asthma knowledge to immediately post-intervention, 2 months, 4 months, and 6 months

**Time Frame:** Baseline, immediately post-intervention, 2 months, 4 months, 6 months

**Description:** Patient satisfaction measured by the Client Satisfaction Questionnaire-8

**Measure:** Patient satisfaction measured by the Client Satisfaction Questionnaire-8

**Time Frame:** Immediately post-intervention at the baseline visit, 2 months, 4 months, 6 months

**Description:** Time spent in using the mobile application

**Measure:** Time spent in using the mobile application

**Time Frame:** Immediately post-intervention at the baseline visit

**Description:** Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)

**Measure:** Asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ)

**Time Frame:** Baseline, 2 months, 4 months, 6 months

**Description:** Asthma emergency department visits

**Measure:** Asthma emergency department visits

**Time Frame:** Baseline, 2 months, 4 months, 6 months

**Description:** Asthma hospitalizations

**Measure:** Asthma hospitalizations

**Time Frame:** Baseline, 2 months, 4 months, 6 months

**Description:** Asthma-related steroid courses

**Measure:** Asthma-related steroid courses

**Time Frame:** Baseline, 2 months, 4 months, 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria: Adults (\>18 years) with: (a) severe asthma (i.e. at least one asthma-related ED visit and/or hospitalization in the previous year); (b) access to a smartphone with short message service (SMS) capability; (c) English speaking; (d) able to give informed consent.

Exclusion Criteria: (a) use of oral corticosteroids in the 2 weeks prior to the baseline visit; (b) pregnancy; (c) severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol; and (d) patients that previously received the ASTHMAXcel application.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bronx

**Country:** United States

**Facility:** Montefiore Medical Center

**State:** New York

**Zip:** 10467

#### Overall Officials

**Official 1:**

**Affiliation:** Montefiore Medical Center

**Name:** Sunit Jariwala

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** The investigators will share de-identified and aggregated study findings.

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001982

- Term: Bronchial Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000008171

- Term: Lung Diseases

- ID: D000012130

- Term: Respiratory Hypersensitivity

- ID: D000006969

- Term: Hypersensitivity, Immediate

- ID: D000006967

- Term: Hypersensitivity

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4556

- Name: Asthma

- Relevance: HIGH

- As Found: Asthma

- ID: M5258

- Name: Bronchial Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M14967

- Name: Respiratory Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M10020

- Name: Hypersensitivity, Immediate

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001249

- Term: Asthma

### Misc Info Module

- Version Holder: 2024-05-24
