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Personalized Mobile Phone Video Recording to Improve Inhaler Techniques in Asthma Patients. (RECORD)

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Personalized Mobile Phone Video Recording
Sponsored by
Penang Hospital, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring inhaler technique, compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 years old and above
  2. Informed consent
  3. Established clinical diagnosis of asthma by patient's treating doctor
  4. Prescribed with inhalers (any type) for therapeutic indication for at least 3 months

Exclusion Criteria:

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

Sites / Locations

  • Penang General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Personalized Mobile Phone Video Recording in addition to Standard care

Standard care alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Asthma Control
Mean score of Asthma Control Questionnaire (ACQ)
Inhaler Technique
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
Inhaler Technique Error
Number of errors committed by patients according to checklist

Full Information

First Posted
August 4, 2020
Last Updated
August 6, 2020
Sponsor
Penang Hospital, Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04503837
Brief Title
Personalized Mobile Phone Video Recording to Improve Inhaler Techniques in Asthma Patients.
Acronym
RECORD
Official Title
A Randomized Control Trial to Evaluate the Effectiveness of Personalized Mobile Phone Video Recording in Addition to Standard Care Compared to Standard Care Alone in Improving Inhaler Technique Among Patients With Asthma. (RECORD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penang Hospital, Malaysia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a single-centre, randomized, controlled, parallel group, assessor-blinded trial to evaluate the effectiveness of Personalized Mobile Phone Video Recording in addition to standard care, compared to standard care alone, in improving inhaler technique among patients with asthma. Patients are randomised to either Personalized Video Recording with standard clinical practice group (intervention) or to standard clinical practice group (control) in 1:1 ratio. Subject's inhaler technique assessment is performed by using a standard checklist of steps according to the type of inhaler used by subject. All inhaler technique assessment and asthma control questionnaire will be administered before the intervention/control treatment by a blinded assessor. Both intervention and control treatment will be administered by the same investigators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
inhaler technique, compliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
All outcome assessment - inhaler technique assessment and asthma control questionnaire will be administered by a blinded assessor.
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Personalized Mobile Phone Video Recording in addition to Standard care
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard care alone
Intervention Type
Procedure
Intervention Name(s)
Personalized Mobile Phone Video Recording
Intervention Description
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.
Primary Outcome Measure Information:
Title
Inhaler Technique
Description
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Asthma Control
Description
Mean score of Asthma Control Questionnaire (ACQ)
Time Frame
1, 3 and 6 months
Title
Inhaler Technique
Description
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
Time Frame
1 and 3 months
Title
Inhaler Technique Error
Description
Number of errors committed by patients according to checklist
Time Frame
1, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Choon Seong Ang, MBChB
Phone
0103837286
Email
angchoonseong@hotmail.com
Facility Information:
Facility Name
Penang General Hospital
City
George Town
State/Province
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHOON SEONG ANG, MBChB
Phone
0103837286
Email
angchoonseong@hotmail.com
First Name & Middle Initial & Last Name & Degree
Irfhan Ali Hyder Ali, MBBS
First Name & Middle Initial & Last Name & Degree
Chee Kin Yoon, MBBS
First Name & Middle Initial & Last Name & Degree
Yen Li Lim, BPharm
First Name & Middle Initial & Last Name & Degree
Kelvin Khai Meng Beh, MD
First Name & Middle Initial & Last Name & Degree
Choon Seong Ang, MBChB

12. IPD Sharing Statement

Plan to Share IPD
No

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Personalized Mobile Phone Video Recording to Improve Inhaler Techniques in Asthma Patients.

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