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

NCT03248895 | Completed

• 1 other identifier: QUB B14/39
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Inhaler assessment; Direct observation of therapy

Outcome Measures

Primary Outcomes (11)

• Clinician assessment of asthma control

  Clinician assessment of degree of disease control recorded at baseline and during follow-up period

  Recruitment - 18 weeks post intervention

• Clinician assessment of asthma severity

  Clinician assessment of asthma severity recorded at baseline and during follow-up period

  Recruitment - 18 weeks post intervention

• Asthma medication profile

  Current medication profile and any changes made

  Recruitment - 18 weeks post intervention

• Number of asthma attacks

  Number of attacks taken during follow-up period

  Recruitment - 18 weeks post intervention

• Oral corticosteroids courses

  Numbers of courses of oral corticosteroids taken during follow-up period

  Recruitment - 18 weeks post intervention

• Attendances at Emergency Department (ED)

  Numbers of attendances to ED during follow-up period

  Recruitment - 18 weeks post intervention

• Spirometry measurement; Fraction of exhaled nitric oxide (FeNO)

  Measurements taken at each intervention

  Recruitment - 18 weeks post intervention

• Self reported Medication Adherence Report Scale (MARS)

  Parent/guardian completes MARS if child younger than 9yrs old

  Recruitment - 18 weeks post intervention

• Interview-administered Paediatric Asthma Quality of Life Questionnaire (PAQOLQ) or Paediatric Asthma Caregiver Quality of Life Questionnaire (PACQOLQ)

  PAQOLQ if 9 years or older; PACQOLQ if under 9

  Recruitment - 18 weeks post intervention

• Interview-administered Asthma Control Test (ACT) or Childhood Asthma Control (C-ACT)

  Recruitment - 18 weeks post intervention

• ICS inhaler technique

  Recruitment - 18 weeks post intervention

Study Arms (2)

Immediate (I-med)

ACTIVE COMPARATOR

Participants allocated to the I-med group will take part in the mobile DOT intervention for the first 6 weeks. Outcomes will be evaluated at the start (week 0) and end of the 6 week intervention period and during clinic visits at weeks 12 and 18 for follow-up

Device: Mobile Direct Observation of Therapy (MDOT)

Delayed (D-med)

ACTIVE COMPARATOR

Those participants allocated to the D-med group will have the DOT intervention started after a 6 week "intervention-free" interval with usual Asthma Clinic care. Outcomes in the D-med group will be assessed at baseline (week 0), week 6 (intervention start), week 12 (end of intervention), and at weeks 18 and 24 for follow-up.

Device: Mobile Direct Observation of Therapy (MDOT)

Interventions

Mobile Direct Observation of Therapy (MDOT) DEVICE

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.

Delayed (D-med); Immediate (I-med)

Eligibility Criteria

• Age: 2 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children and young people aged from 2-16 years with apparent partially controlled or uncontrolled DTA. The children will have asthma symptoms despite being prescribed ICS (\> 400 mcg/day for children \< 5 years, 800 mcg/day for children \> 5 years) and a second line therapy such as a LABA, LTRA, or theophylline (Nagakumar and Thomas, 2013).
• One member of the household has access to a smartphone, tablet or other mobile device that is capable submitting a video image to an internet accessible repository. This person must have access to the device for the entire period of the intervention phase (6 weeks) of the study.

You may not qualify if:

• Children whose asthma symptoms are controlled.
• Children and/or parents without access or unwilling to allow use of a suitable mobile device for the study.

Sponsors & Collaborators

• Queen's University, Belfast: lead

Study Officials

• Mike Shields, PhD

  Queen's University, Belfast

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomised intervention trial will be used. Participants will be randomised to either an immediate (I-med) or a delayed (D-med) intervention. Randomisation will be restricted based on two factors including age and patient gender. Both subject groups will receive standard-of-practice asthma education and management in the Asthma Clinic prior to study enrolment. Participants allocated to the I-med group will take part in the mobile technology DOT intervention for the first 6 weeks. Outcomes will be evaluated at the start (week 0) and end of the 6 week intervention period and during clinic visits at weeks 12 and 18 for follow-up. Those participants allocated to the D-med group will have the DOT intervention started after a 6 week "intervention-free" interval with usual Asthma Clinic care.

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 15, 2017
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 17, 2017

Record last verified: 2017-08