NCT04503837

Brief Summary

To investigate the effectiveness of addition of recording video of the patient performing inhaler techniques using mobile phone for discussion with the patient, to standard care inhaler education compared to standard care inhaler education alone, in improving inhaler technique of asthma patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
234

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

8 months

First QC Date

August 4, 2020

Last Update Submit

August 6, 2020

Conditions

Keywords

inhaler techniquecompliance

Outcome Measures

Primary Outcomes (1)

  • Inhaler Technique

    Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)

    6 months

Secondary Outcomes (3)

  • Asthma Control

    1, 3 and 6 months

  • Inhaler Technique

    1 and 3 months

  • Inhaler Technique Error

    1, 3 and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Personalized Mobile Phone Video Recording in addition to Standard care

Procedure: Personalized Mobile Phone Video Recording

Control

NO INTERVENTION

Standard care alone

Interventions

Subjects will be asked to perform inhaler technique while on video recording. The video will be shown to subjects immediately during technique education session and mistakes (if any) will be pointed out to subject.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old and above
  • Informed consent
  • Established clinical diagnosis of asthma by patient's treating doctor
  • Prescribed with inhalers (any type) for therapeutic indication for at least 3 months

You may not qualify if:

  • Unable to converse/understand Malay or English
  • Not able to perform inhalation on his/her own self
  • Using spacer/valved holding chamber in addition to MDI
  • Not able to comply with study procedures in the opinion of investigators
  • More than two different types of inhaler which require different techniques

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penang General Hospital

George Town, Pulau Pinang, 10990, Malaysia

Location

MeSH Terms

Conditions

AsthmaPatient Compliance

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Choon Seong Ang, MBChB

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All outcome assessment - inhaler technique assessment and asthma control questionnaire will be administered by a blinded assessor.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Physician, Clinical Research Centre

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 7, 2020

Study Start

September 1, 2020

Primary Completion

April 30, 2021

Study Completion

April 30, 2021

Last Updated

August 7, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations