STudy of Asthma Adherence Reminders (STAAR)

NHS Foundation Trust logo

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)

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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