Personalized Mobile Phone Video Recording to Improve Inhaler Techniques in Asthma Patients. (RECORD)
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)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Penang
-
George Town, Penang, Malaysia, 10990
- Penang General Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Styre
Standard omsorg alene
|
|
|
Eksperimentell: Intervention
Personalized Mobile Phone Video Recording in addition to Standard care
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Inhaler Technique
Tidsramme: 6 months
|
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Asthma Control
Tidsramme: 1, 3 and 6 months
|
Mean score of Asthma Control Questionnaire (ACQ)
|
1, 3 and 6 months
|
|
Inhaler Technique
Tidsramme: 1 and 3 months
|
Correct inhaler technique (able to do all the steps of inhaler technique, as stipulated in checklist of subject's inhaler)
|
1 and 3 months
|
|
Inhaler Technique Error
Tidsramme: 1, 3 and 6 months
|
Number of errors committed by patients according to checklist
|
1, 3 and 6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HPP/CTP/RECORD/01
Plan for individuelle deltakerdata (IPD)
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