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

Asthma Clinical Trial

— 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04503837
• Other study ID #: HPP/CTP/RECORD/01
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: August 2020
• Source: Penang Hospital, Malaysia
• Contact: Choon Seong Ang, MBChB
• Phone: 0103837286
• Email: angchoonseong[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 234
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Personalized Mobile Phone Video Recording
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.

Locations

Country	Name	City	State
Malaysia	Penang General Hospital	George Town	Penang

Sponsors (1)

Lead Sponsor	Collaborator
Penang Hospital, Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Asthma Control	Mean score of Asthma Control Questionnaire (ACQ)	1, 3 and 6 months
Secondary	Inhaler Technique	Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)	1 and 3 months
Secondary	Inhaler Technique Error	Number of errors committed by patients according to checklist	1, 3 and 6 months