Electronic Monitoring Combined With Weekly Feedback and Reminders

Study Overview
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Brief Summary
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A total of 96 recruited children (aged 6 months to 3 years) with mild or moderate persistent asthma who were on regular inhaled corticosteroids (ICS) were randomly allocated to receive electronic monitoring combined with instant messaging software -based weekly feeding back adherence and reminders to keep taking the ICS (intervention group) and to receive electronic monitoring only (control group). The device-monitored adherence rates and caregiver-reported adherence rates were analyzed.

Official Title
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The Effect of Electronic Monitoring Combined With Weekly Feedback and Reminders on Adherence to Inhaled Corticosteroids in Infants and Younger Children With Asthma: a Randomized Controlled Trial

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: intervention group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients having mild or moderate persistent asthma 6 months-3 years taking regular inhaled steroids, with no change in their medication in the last month. Exclusion Criteria: Participants who had severe persistent asthma or another respiratory disease or did not live in Shanghai were excluded.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The Study of Asthma Adherence study was a multicentre, single-blind, parallel group randomised controlled trial, with an allocation ratio of 1:1.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>All the device-monitored adherence data from the previous week were downloaded from the background database and calculated by a qualified asthma nurse. Through free IMS (WeChat; Tencent, Shenzhen, CHN) available on mobile, the nurse offered feedback to the caregivers weekly according to the adherence rate and reminded them to keep taking the ICS. Caregivers were asked monthly Has our child inhaled the medicine according to the doctor's instructions? and How about the frequency? by telephone. | Behavioral: intervention group<br>* All the device-monitored adherence data from the previous week were downloaded from the background database and calculated by a qualified asthma nurse. Through free IMS (WeChat; Tencent, Shenzhen, CHN) available on mobile, the nurse offered feedback to the caregivers weekly according to the adherence rate and reminded them to keep taking the ICS. Caregivers were asked monthly Has our child inhaled the medicine according to the doctor's instructions? and How about the frequency? by telephone.<br>|
| No Intervention: control group<br>All the device-monitored adherence data were downloaded from the background database and calculated weekly. However, feedback and reminders were not given to the caregivers. Caregivers were also asked monthly Has our child inhaled the medicine according to the doctor's instructions? and How about the frequency? by telephone. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| device monitored adherence rate | The primary outcome of the study was change in the adherence rate monitored by the electronic device for 6 consecutive months. This adherence rate was calculated as the number of device recorded times /number of total times prescribed × 100%. | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caregiver-reported adherence rate | The secondary outcomes for the study were the caregiver-reported adherence rate and the difference between device-monitored and caregiver-reported adherence rates for 6 consecutive months. The caregiver-reported adherence rate was recorded on a monthly basis. It was offered by the caregivers of patients through answering the questions Has our child inhaled the medicine according to the doctor's instructions and How about the frequency. The device-monitored and caregiver-reported adherence rates were compared monthly. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric, asthma adherence, electronic device