## Protocol Section
### Identification Module
**NCT ID:** NCT04250779

**Acronym:** MOMMIASTHMA1

**Brief Title:** Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence

**Official Title:** Evaluating Efficacy of Smart Device in Assisting With Inhaler Technique and Adherence

#### Organization Study ID Info
**ID:** MOMMIASTHMA1
#### Organization
**Class:** OTHER
**Full Name:** Landon Pediatric Foundation
### Status Module
#### Completion Date
**Date:** 2021-12-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2020-09-16

**Type:** ACTUAL

**Last Update Submit Date:** 2020-09-13

**Overall Status:** UNKNOWN

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

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-07-01

**Type:** ACTUAL

**Status Verified Date:** 2020-01

#### Study First Post Date
**Date:** 2020-01-31
**Type:** ACTUAL
**Study First Submit Date:** 2020-01-29
**Study First Submit QC Date:** 2020-01-29
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Cognita Labs LLC

#### Lead Sponsor

**Class:** OTHER

**Name:** Landon Pediatric Foundation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Asthma affects over 10 million children in the U.S., and poses a significant health and cost burden. Metered dose inhaler (MDI) is the most common method of treatment. Studies show that up to 80% of patients demonstrate incorrect use of MDIs, which results in suboptimal medication delivery to the lungs.

Asthma control can be followed by symptoms, rescue medication usage and measures of airflow obstruction. Current options to monitor control include an asthma diary (relies on consistent use by the patient), pharmacy records of medication dispensing (dispensing does not equal usage), and peak expiratory flow (PEF) meters (significant variability in technique leading to inconsistent results).

CapMedic is a smart inhaler and home spirometer device which aims to assist with correct MDI usage and to monitor asthma control. CapMedic fits on top of the MDI inhaler and provides live audio-visual-haptic cues to guide the patient for correctly using their inhaler. CapMedic includes a built-in forced expiratory flow in 1 second (FEV1, a measure of airflow) and PEF meter. It will utilize the same audio-visual-haptic hardware to implement live cues that encourage patient's effort in performing accurate at-home FEV1/PEF test. Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary.

**Detailed Description:** CapMedic is a smart inhaler and home spirometer device which aims to assist with correct MDI usage and to monitor asthma control. CapMedic fits on top of the MDI inhaler and provides live audio-visual-haptic cues to guide the patient for correctly using their inhaler. CapMedic includes a built-in forced expiratory flow in 1 second (FEV1, a measure of airflow) and PEF meter. It will utilize the same audio-visual-haptic hardware to implement live cues that encourage patient's effort in performing accurate at-home FEV1/PEF test. Cap will also be able to log medication usage and Medic application will allow patients to keep an asthma symptom diary.

### Conditions Module

**Conditions:**

- Asthma

- Adherence, Medication

- Childhood Asthma

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Research will initially involve collection of data describing the participants' current use of their medication following standard education. Subsequent phases will add audio / haptic coaching to the process of administering medication by MDI, and follow the same participants to determine whether or not there is improvement in technique and adherence to therapy.

The device will be used with a placebo inhaler (given AFTER the participant's regular medication is taken by standard techniques), to determine how participants use the device, and to identify the most effective coaching interventions for this age group. This is to ensure that the device does not interfere with delivery of routine asthma controller medications. The data will be used to develop a subsequent, longer term study in which we will evaluate the effect of the coaching device on asthma control, when it is used with the subject's controller medication.

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** In this arm, patients are provided with standard-of-care instructions on using MDIs correctly and regularly at home. The MDI usage is recorded using CapMedic device with active guidance turned off.

**Intervention Names:**

- Behavioral: Video-based guidance

**Label:** Control Group

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** In this arm, patients are provided with active guidance from CapMedic device on using MDIs correctly and regularly at home. The MDI usage is recorded using CapMedic device with active guidance turned on.

**Intervention Names:**

- Device: CapMedic smart inhaler device

**Label:** Treatment Group

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment Group

**Description:** The CapMedic device provides active coaching to promote correct and regular use of MDI.

**Name:** CapMedic smart inhaler device

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Control Group

**Description:** Patients are shown a video of how to use inhalers correctly and any questions are answered by the clinician. They are also encouraged to use inhalers regularly and correctly at home.

**Name:** Video-based guidance

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Correctness of Inhaler Use measured using CapMedic device during recruitment. Competence is measured as a score out of 4 for 4 steps of MDI use: 1. Shaking, 2. Orientation, 3. Coordination 4. Duration of inhalation

**Measure:** MDI use Competence in Clinic

**Time Frame:** 1 day

**Description:** Correctness of Inhaler Use measured using CapMedic device at home. Competence is measured as a score out of 4 for 4 steps of MDI use: 1. Shaking, 2. Orientation, 3. Coordination 4. Duration of inhalation

**Measure:** MDI use Competence at home

**Time Frame:** 8 weeks

#### Secondary Outcomes

**Description:** PEF measured using CapMedic device during recruitment. PEF is measured in L/min.

**Measure:** PEF Lung Function in Clinic

**Time Frame:** 1 day

**Description:** FEV1 measured using CapMedic device during recruitment. FEV1 is measured in L.

**Measure:** FEV1 Lung Function in Clinic

**Time Frame:** 1 day

**Description:** PEF measured using CapMedic device at home. PEF is measured in L/min.

**Measure:** PEF Lung Function at home

**Time Frame:** 8 weeks

**Description:** FEV1 measured using CapMedic device at home. FEV1 is measured in L.

**Measure:** FEV1 Lung Function at home

**Time Frame:** 8 weeks

**Description:** Regularity of MDI use measured by CapMedic device at home, measured as a % of puffs taken per week compared to prescribed dosage.

**Measure:** MDI use Adherence

**Time Frame:** 8 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Diagnosis of Asthma
* Regular user of MDI
* Asthma Control Test (ACT) scores between 15 and 25
* FEV1 between 60-80% of predicted (persistent mild-moderate)
* Disease severity in the range mild-moderate
* Access to a Smartphone and internet during the entire duration of the study.
* Cognitively able to utilize the device and express interest in participating.

Exclusion Criteria:

* Patients without asthma
* With developmental disabilities
* Do not speak English
* Do not own a Smartphone

**Minimum Age:** 8 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** chris.landon@ventura.org

**Name:** Chris Landon, M.D.

**Phone:** 8053401366

**Role:** CONTACT

**Contact 2:**

**Email:** emilieparonyann@gmail.com

**Name:** Emilie Paronyan

**Phone:** 8184393664

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ventura

**Contacts:**

***Contact 1:***

- **Email:** chris.landon@ventura.org

- **Name:** Chris Landon, MD

- **Phone:** 805-641-4490

- **Role:** CONTACT

***Contact 2:***

- **Name:** Chris Landon, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Pediatric Diagnostic Center

**State:** California

**Status:** RECRUITING

**Zip:** 93003

### References Module

#### References

**Citation:** Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.

**PMID:** 35691614

## 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
