NCT03277664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
Last Updated

November 5, 2019

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

September 6, 2017

Last Update Submit

November 1, 2019

Conditions

Asthma

Keywords

pediatricasthma adherenceelectronic device

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • caregiver-reported adherence rate

    up to 6 months

Study Arms (2)

intervention group

EXPERIMENTAL

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.

Behavioral: intervention group

control group

NO INTERVENTION

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.

Interventions

intervention groupBEHAVIORAL

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.

intervention group

Eligibility Criteria

Age6 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • patients having mild or moderate persistent asthma
  • months-3 years
  • taking regular inhaled steroids, with no change in their medication in the last month.

You may not qualify if:

  • Participants who had severe persistent asthma or another respiratory disease or did not live in Shanghai were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai children's medical center

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (1)

  • 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.

    PMID: 32922454DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The Study of Asthma Adherence study was a multicentre, single-blind, parallel group randomised controlled trial, with an allocation ratio of 1:1.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 11, 2017

Study Start

September 1, 2016

Primary Completion

January 31, 2017

Study Completion

January 31, 2017

Last Updated

November 5, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)