Electronic Monitoring Combined With Weekly Feedback and Reminders

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03277664
• Other study ID #: ESR-15-11001
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: January 31, 2017

Study information

• Verified date: November 2019
• Source: Shanghai Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 3 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Shanghai children's medical center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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