Asthma
Conditions
Keywords
pediatric, asthma adherence, electronic device
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.
Interventions
BEHAVIORALintervention 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.
Sponsors
Shanghai Children's Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
6 Months to 3 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| device monitored adherence rate | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| caregiver-reported adherence rate | 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. |
Countries
China
Outcome results
None listed