NCT05322044

Brief Summary

The aim of this pilot randomised controlled trial is to assess the effectiveness of a short-term financial incentives intervention at bringing about behaviour change, namely short-medium term improvements in inhaled corticosteroid (ICS) adherence and asthma control in children and young people (CYP) with asthma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

July 18, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 5, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

March 16, 2022

Results QC Date

July 22, 2024

Last Update Submit

February 3, 2025

Conditions

Asthma in ChildrenMedication Adherence

Keywords

Electronic monitoring deviceFinancial incentivesRemindersAsthma control

Outcome Measures

Primary Outcomes (1)

  • Comparison of Percentage ICS Adherence Between Groups at 12-weeks

    Comparison of average % ICS adherence measured by EMD for intervention group participants and average % ICS adherence measured by EMD for control group participants at 12-weeks (post-intervention period). EMD will electronically record date/time of asthma inhaler actuation. Data from EMD will be downloaded at study visit/s. Possible scores: 0% (poor adherence) to 100% (good adherence).

    Comparison between groups at study visit 2 (12-weeks)

Secondary Outcomes (18)

  • Proportion of Participants Achieving Good Asthma Adherence (≥80%)

    study visit 2 (12-weeks) and study visit 3 (24-weeks)

  • Number of Asthma Exacerbation Needing a Course of Oral Corticosteroids (OCS)

    study visit 2 (12-weeks) and study visit 3 (24-weeks)

  • Asthma Control

    study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  • Exhaled Nitric Oxide

    study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  • Brief Illness Perceptions Questionnaire (B-IPQ)

    study visit 1 (0 weeks), study visit 2 (12-weeks) and study visit 3 (24-weeks)

  • +13 more secondary outcomes

Study Arms (2)

Control (no financial incentive)

NO INTERVENTION

No incentive. Usual care (plus EMD with reminders) for 12-weeks.

Intervention (financial incentive)

EXPERIMENTAL

Financial incentive dependent upon daily medication adherence (plus EMD with reminders) for 12-weeks.

Behavioral: Financial incentives

Interventions

Financial incentivesBEHAVIORAL

Financial incentives dependent upon adherence will be given to participants alongside additional EMD associated app features for 12-weeks.

Intervention (financial incentive)

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent obtained from parent/guardian and assent from child.
  • CYP with doctor diagnosed asthma presenting to Emergency Department (ED) with a severe asthma exacerbation (as defined by ERS/ATS guidelines).
  • Aged between 11 and 17 years old
  • Prescribed maintenance inhaled corticosteroids (ICS) (which can include maintenance and reliever therapy MART) for at least 6-months.
  • Own their own mobile smartphone (running Android 8 or higher, or iOS 13 or higher)
  • Prescribed the following inhalers: Clenil, Flixotide, Symbicort, Seretide

You may not qualify if:

  • Parent/guardian / CYP unable to provide consent / assent
  • CYP with other, co-existing respiratory conditions
  • Parent/guardian/CYP who are not fluent or able to understand the information provided in English.
  • CYP who are involved in other intervention research studies (including CTIMPs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Results Point of Contact

Title
Dr Louise Fleming
Organization
Imperial College London
l.fleming@imperial.ac.uk
02073528121

Study Officials

  • Ian Maconochie

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2022

First Posted

April 11, 2022

Study Start

July 18, 2022

Primary Completion

July 11, 2023

Study Completion

September 28, 2023

Last Updated

February 5, 2025

Results First Posted

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)