Back to resultsElectronic Monitoring Combined With Weekly Feedback and Reminders
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intervention group
Sponsored by
About this trial
This is an interventional health services research trial for Asthma focused on measuring pediatric, asthma adherence, electronic device
Eligibility Criteria
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.
Sites / Locations
- Shanghai children's medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
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 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.
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03277664
First Posted
September 6, 2017
Last Updated
November 1, 2019
Sponsor
Shanghai Children's Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03277664
Brief Title
Electronic Monitoring Combined With Weekly Feedback and Reminders
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Children's Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
pediatric, asthma adherence, electronic device
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
Due to the nature of the intervention, the caregivers of the participants and follow-up nurse were not blinded. But the doctors and statisticians were blinded. Both in the intervention group and control group, adherence data were not available to clinicians.
Allocation
Randomized
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
intervention group
Intervention Description
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 Measure Information:
Title
device monitored adherence rate
Description
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%.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
caregiver-reported adherence rate
Description
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.
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Shanghai children's medical center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32922454
Citation
Chen J, Xu J, Zhao L, Zhang J, Yin Y, Zhang F. 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. Allergy Asthma Clin Immunol. 2020 Jul 29;16:68. doi: 10.1186/s13223-020-00466-6. eCollection 2020.
Results Reference
derived
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Electronic Monitoring Combined With Weekly Feedback and Reminders
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