Electronic Monitoring Combined With Weekly Feedback and Reminders

November 1, 2019 updated by: Shanghai Children's Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Shanghai Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: control group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
device monitored adherence rate
Time Frame: 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%.
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
caregiver-reported adherence rate
Time Frame: 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.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

January 31, 2017

Study Registration Dates

First Submitted

September 6, 2017

First Submitted That Met QC Criteria

September 7, 2017

First Posted (Actual)

September 11, 2017

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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