Clinical trial NCT04250779: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Asthma
Adherence, Medication
Childhood Asthma
Lead sponsor: Landon Pediatric Foundation
Sponsor class: OTHER
Collaborators: name: Cognita Labs LLC
First posted: 2020-01-31
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: MDI use Competence in Clinic
timeFrame: 1 day
measure: MDI use Competence at home
timeFrame: 8 weeks
Secondary outcomes:
measure: PEF Lung Function in Clinic
timeFrame: 1 day
measure: FEV1 Lung Function in Clinic
timeFrame: 1 day
measure: PEF Lung Function at home
timeFrame: 8 weeks
measure: FEV1 Lung Function at home
timeFrame: 8 weeks
measure: MDI use Adherence
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Pediatric Diagnostic Center
state: California
Study officials:
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.