- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03277664
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
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:
- 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.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESR-15-11001
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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