Electronic Monitoring Combined With Weekly Feedback and Reminders

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: intervention group

• Registration Number: NCT03277664
• Lead Sponsor: Shanghai Children's Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-01
• Primary Completion: 2017-01-31
• Study Completion: 2017-01-31
• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-11
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-01
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. patients having mild or moderate persistent asthma
2. 6 months-3 years
3. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	intervention group	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.

Primary Outcome Measures

Name	Time	Method
device monitored adherence rate	up to 6 months	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%.

Secondary Outcome Measures

Name	Time	Method
caregiver-reported adherence rate	up to 6 months	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.

Trial Locations

Locations (1)

Shanghai children's medical center; 🇨🇳 Shanghai, Shanghai, China