AsthmaRECORDNCT04503837
Personalized Mobile Phone Video Recording to Improve Inhaler Techniques in Asthma Patients.
A study testing Personalized Mobile Phone Video Recording in people with Asthma, run by Penang Hospital, Malaysia at 1 site in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Personalized Mobile Phone Video Recording
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Sep 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Penang General Hospital
George Town, Pulau Pinang, 10990
CHOON SEONG ANG, MBChB, 0103837286, angchoonseong@hotmail.com
Irfhan Ali Hyder Ali, MBBS
About this study
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)
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Personalized Mobile Phone Video Recording
- Keywords
- inhaler technique, compliance
- Medical subject headings
- Asthma, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Mobile Phone Video RecordingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Personalized Mobile Phone Video Recording in addition to Standard care Receives: Procedure: Personalized Mobile Phone Video Recording |
| Control | No intervention | Standard care alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inhaler Technique
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
Measured: 6 months
Secondary outcomes (3)
Asthma Control
Mean score of Asthma Control Questionnaire (ACQ)
Measured: 1, 3 and 6 months
Inhaler Technique
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
Measured: 1 and 3 months
Inhaler Technique Error
Number of errors committed by patients according to checklist
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion30 Apr 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penang Hospital, Malaysia
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Choon Seong Ang, Penang Hospital, Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503837
- Sponsor's protocol ID
- HPP/CTP/RECORD/01
- Acronym
- RECORD
- Status last verified
- Aug 2020
- First submitted
- 4 Aug 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04503837
- Acronym / sponsor ID
- RECORD / HPP/CTP/RECORD/01
- Conditions
- Asthma
- Keywords
- inhaler technique, compliance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Penang Hospital, MalaysiaOther government
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 30 Apr 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Personalized Mobile Phone Video RecordingPersonalized Mobile Phone Video Recording in addition to Standard care |
| Control | No intervention | –Standard care alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Mobile Phone Video RecordingSubjects 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. | Procedure or surgery | Intervention |
Primary outcome
Inhaler Technique
Time frame: 6 months
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
3 secondary outcomes
Asthma Control
Time frame: 1, 3 and 6 months
Inhaler Technique
Time frame: 1 and 3 months
Inhaler Technique Error
Time frame: 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Mobile Phone Video Recording in people with Asthma, run by Penang Hospital, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Choon Seong Ang, MBChB (0103837286, angchoonseong@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inhaler Technique (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.