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Evaluation of a Mobile Direct Observation Therapy (DOT) Approach in Children and Young People With Asthma

NCT03248895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-08-17

No results posted yet for this study

Summary

Mobilte Direct Observation Therapy (MDOT) is a technology has the potential to be a cost effective approach to direct observation of therapy administration, the latter being one of the most accurate methods of evaluating adherence. Use to date, as confirmed by the rapid systematic review, has been limited mainly to TB and sickle cell disease and there have been no published reports on the use of MDOT to monitor inhaled therapy. Due to the increasing incidence of childhood asthma worldwide, there is a need for new innovative approaches to support children and their parents with asthma management, especially since national and international guidelines have advised healthcare providers to periodically assess inhaler use as part of asthma management.

Conditions

  • Asthma in Children

Interventions

DEVICE

Mobile Direct Observation of Therapy (MDOT)

Patients who are enrolled in the study will be randomised into two groups (I-med or D-med) to receive Mobile Direct Observation of Therapy (MDOT). Participants or parents/guardians of participants will be asked to capture a DOT video twice daily (morning and evening) on their mobile devices of ICS use by the patient. In the I-med group, participants will be asked to upload daily video recordings via the internet to a repository for a 6 week period at the start of the study. Participants in the D-med group will be free from DOT for the first 6 weeks of the study and will be asked to carry out their usual therapy management. After that, DOT as described above will be applied for the next 6 weeks.

Sponsors & Collaborators

  • Queen's University, Belfast

    lead OTHER

Principal Investigators

  • Mike Shields, PhD · Queen's University, Belfast

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-09-30
Completion
2016-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03248895 on ClinicalTrials.gov