STudy of Asthma Adherence Reminders (STAAR)

NHS Foundation Trust

Status: Completed

Conditions: Childhood Asthma

Treatments: Device: Activated Smartinhaler or Smartturbo; Device: Deactivated Smartinhaler or Smartturbo; Other: Feedback of adherence data

Study type: Interventional

Funder types: Other

Identifiers

NCT02451709

SCH/13/041

Details and patient eligibility

About

To determine whether electronic adherence monitoring with feedback and reminder alarms can improve adherence and health outcomes in childhood asthma.

Full description

This study will investigate whether adding an electronic adherence monitor to inhaled steroids, and feeding this information back to patients and families can improve adherence and outcomes in childhood asthma. The devices will also sound twice daily reminder alarms to act as direct medication prompts. This intervention will be compared to a control group in which adherence is monitored, but with no feedback or alarms.

Enrollment: 90 patients

Sex: All

Ages: 6 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Doctor diagnosed asthma.

• On at least BTS stage 2, which means they will be on regular inhaled steroids.

• No change in regular asthma treatment in the last 1 month (on regular inhaled steroids, no change in steroid dose for

  1 month, no change in add on therapy in the last month).

• ACQ (Asthma Control Questionnaire) score more than or equal to 1.5.

• Can speak and understand English.

Exclusion criteria

• BTS stage 5 asthma (complex issues, too unstable).
• Recent changes to asthma treatment within the last month. (see above)
• ACQ (Asthma Control Questionnaire) score < 1.5.
• Another chronic health condition (eg diabetes, congenital heart disease, cystic fibrosis).
• Can't speak or understand English.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Feedback and alarms

Experimental group

Description:

Standard education about importance of inhaled steroids and regular adherence to inhaled steroids after recruitment to study. Randomized to receive an electronic adherence device ( activated smartinhaler or smartturbo - Nexus 6) with twice daily alarm reminders activated. Patient decides times, different times on weekdays and weekends if required. This device fitted to their regular preventer inhaler, patient aware of its presence and its purpose in the context of the study. Reviewed in standard asthma clinic every 3 months for 12 months. At each clinic visit, adherence information downloaded from device and data shared with patient and family (feedback of adherence data). Discussion about adherence rates, and action planning for the next 3 months to improve adherence if necessary.

Treatment:

Other: Feedback of adherence data

Device: Activated Smartinhaler or Smartturbo

No feedback or alarms

Active Comparator group

Description:

Standard education about importance of inhaled steroids and regular adherence to inhaled steroids after recruitment to study. Randomized to receive an electronic adherence device. Deactivated Smartinhaler or Smartturbo. Device not activated to play reminder alarms. This device fitted to their regular preventer inhaler, patient aware of its presence and its purpose in the context of the study. Reviewed in standard asthma clinic every 3 months for 12 months. At each clinic visit, adherence information downloaded from device but data not shared with patient, and no adherence discussion.

Treatment:

Device: Deactivated Smartinhaler or Smartturbo