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Rhinitis, AllergicNCT05286944

Mobile Phone Daily Alarm To Improve Compliance Of Intranasal Corticosteroid Among Allergic Rhinitis Patients.

A study testing Mobile phone alarm reminder in people with Rhinitis, Allergic and Compliance, Medication, run by National University of Malaysia at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a randomized controlled trial to compare the compliance of allergic rhinitis patients towards intranasal steroids between those who use mobile daily alarm reminder and those who do not. Read more about this study

Who is it for?
Ages 15 to 66 years
Conditions the study is for
Rhinitis, Allergic, Compliance, Medication
What is being tested?
Mobile phone alarm reminder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
207 participants
Where
1 siteMalaysia
Study dates
19 Jan 2020to 22 Jun 2022
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 15 to 66 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • • Patients aged 15 years old to 60 years old with persistent AR
  • Positive SPT towards DF, DP, BT, cockroach, Aspergillus, Cat fur
  • Own and able to operate functioning mobile smartphone with built in alarm
  • Able to understand simple instructions
  • Patients who can read in English and Malay
  • Newly diagnosed AR or previous patients who only take intranasal corticosteroid less than 4 times per week

Who cannot join

  • • Patients on immunotherapy
  • Patients with mild intermittent AR
  • Pregnant patients
  • Patient with psychiatric illness
  • Patients with gross anatomical obstruction (severe DNS, gross polyposis, nasal tumour)
  • Chronic rhinosinusitis(CRS) with or without nasal polyposis
  • Patients who have adverse reaction towards INCS
  • Patients with severe hearing loss

Trial locations and contacts

1 site in 1 country.

Malaysia1 site

  • Universiti Kebangsaan Malaysia Medical center

    Kuala Lumpur, WP Kuala Lumpur, 56000

Other trials in Malaysia

About this study

This is a randomized controlled trial to compare the compliance of allergic rhinitis patients towards intranasal steroids between those who use mobile daily alarm reminder and those who do not.

Read the detailed description

In this single blinded RCT, adults with allergic rhinitis are randomized into either he intervention or control arm. The intervention involves installing an alarm with a prerecorded nmessage "Have you take your intranasal steroids" which will automatically ring every day on the patients mobile phone. The control arm do not have any alarm set up. Both groups are offered counseling and education regarding the importance of compliance to intranasal steroid upon recruitment. Daily reminder to take medication may eliminate reason for forgetting medication schedule, hence, improve compliance towards INCS among patients with allergic rhinitis. This study aims to assess the effectiveness of using daily mobile alarm on patient's compliance towards INCS.

Being tested
Mobile phone alarm reminder
Keywords
allergic rhinitis, Intranasal steroid spray, compliance, mobile alarm
Medical subject headings
Rhinitis, Allergic, Medication Adherence, Patient Compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobile phone alarm reminderOther

    Patients are reminded to take their INCS using a mobile phone alarm set to ring daily

Study groups in NCT05286944
Study groupRoleWhat they receive
Mobile daily alarmExperimentalA mobile smartphone with functioning alarm system and solely owned by the patient. The alarm will be set by the second investigator to alert the participant between 6am - 10am (based on participant's preference) in the morning daily. A recorded dual-language (English and Malay version) tone for alarm mobile phone will be used. Apart from that participants are also counseled and educated about allergic rhinitis and are also asked to fill up self monitored adherence card to document their nasal steroid intake.
Receives: Other: Mobile phone alarm reminder
ControlNo interventionThis group of participant will receive counseling and education regarding allergic rhinitis and the importance of compliance. Patients are also given a self monitored adherence card to document their nasal steroid intake.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compliance

    Compliance was taken as 2/3rd use of INCS (20 days out of 30) = 20 x 0.38 = 7.6 g reduced weight.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start19 Jan 2020
  3. Primary completion22 Jun 2022 (estimated)
  4. Study completion22 Jun 2022 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Single group
Model description
Single blinded randomized controlled trial
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
207 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05286944
Sponsor's protocol ID
UKM PPI/111/8/JEP-2019-819
Status last verified
Mar 2021
First submitted
10 Mar 2022
Last updated
18 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Katelaris CH, Lai CK, Rhee CS, Lee SH, Yun WD, Lim-Varona L, Quang VT, Hwang J, Singh H, Kim J, Boyle JM, Dhong HJ, Narayanan P, Vicente G, Blaiss M, Sacks R. Nasal allergies in the Asian-Pacific population: results from the Allergies in Asia-Pacific Survey. Am J Rhinol Allergy. 2011 Sep-Oct;25 Suppl 1:S3-15. doi: 10.2500/ajra.2011.25.3674.

    PubMed 22185687

  • Ho TM, Murad S, Kesavapillai R, Singaram SP. Prevalence of allergy to some inhalants among rhinitis patients in Malaysia. Asian Pac J Allergy Immunol. 1995 Jun;13(1):11-6.

    PubMed 7488338

  • Yuen AP, Cheung S, Tang KC, Ho WK, Wong BY, Cheung AC, Ho AC. The skin prick test results of 977 patients suffering from chronic rhinitis in Hong Kong. Hong Kong Med J. 2007 Apr;13(2):131-6.

    PubMed 17406040

  • Stanaland BE. Once-daily budesonide aqueous nasal spray for allergic rhinitis: a review. Clin Ther. 2004 Apr;26(4):473-92. doi: 10.1016/s0149-2918(04)90050-1.

    PubMed 15189745

  • Bridgeman MB. Overcoming barriers to intranasal corticosteroid use in patients with uncontrolled allergic rhinitis. Integr Pharm Res Pract. 2017 May 4;6:109-119. doi: 10.2147/IPRP.S129544. eCollection 2017.

    PubMed 29354557

  • Trangsrud AJ, Whitaker AL, Small RE. Intranasal corticosteroids for allergic rhinitis. Pharmacotherapy. 2002 Nov;22(11):1458-67. doi: 10.1592/phco.22.16.1458.33692.

    PubMed 12432972

  • Wong GW, Leung TF, Ko FW. Changing prevalence of allergic diseases in the Asia-pacific region. Allergy Asthma Immunol Res. 2013 Sep;5(5):251-7. doi: 10.4168/aair.2013.5.5.251. Epub 2013 Mar 18.

    PubMed 24003381

  • Jansen A, Andersen KF, Bruning H. Evaluation of a compliance device in a subgroup of adult patients receiving specific immunotherapy with grass allergen tablets (GRAZAX) in a randomized, open-label, controlled study: an a priori subgroup analysis. Clin Ther. 2009 Feb;31(2):321-7. doi: 10.1016/j.clinthera.2009.02.005.

    PubMed 19302904

  • Marple BF, Fornadley JA, Patel AA, Fineman SM, Fromer L, Krouse JH, Lanier BQ, Penna P; American Academy of Otolaryngic Allergy Working Group on Allergic Rhinitis. Keys to successful management of patients with allergic rhinitis: focus on patient confidence, compliance, and satisfaction. Otolaryngol Head Neck Surg. 2007 Jun;136(6 Suppl):S107-24. doi: 10.1016/j.otohns.2007.02.031.

    PubMed 17512862

  • Loh CY, Chao SS, Chan YH, Wang DY. A clinical survey on compliance in the treatment of rhinitis using nasal steroids. Allergy. 2004 Nov;59(11):1168-72. doi: 10.1111/j.1398-9995.2004.00554.x.

    PubMed 15461597

  • Braido F, Baiardini I, Puggioni F, Garuti S, Pawankar R, Walter Canonica G. Rhinitis: adherence to treatment and new technologies. Curr Opin Allergy Clin Immunol. 2017 Feb;17(1):23-27. doi: 10.1097/ACI.0000000000000331.

    PubMed 27875376

  • Wittig-Wells D, Higgins M, Carter J, Davis E, Holmes E, Jacob A, Samms-McPherson J, Simms S. Impact of a Preset Daily Cell Phone Alarm on Medication Adherence for Aspirin as Antithrombotic Therapy. Orthop Nurs. 2019 Sep/Oct;38(5):311-316. doi: 10.1097/NOR.0000000000000592.

    PubMed 31568119

  • Bousquet J, Van Cauwenberge P, Khaltaev N; Aria Workshop Group; World Health Organization. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol. 2001 Nov;108(5 Suppl):S147-334. doi: 10.1067/mai.2001.118891. No abstract available.

    PubMed 11707753

  • Wan Ishlah L, Gendeh BS. Skin prick test reactivity to common airborne pollens and molds in allergic rhinitis patients. Med J Malaysia. 2005 Jun;60(2):194-200.

    PubMed 16114160

  • Pizzulli A, Perna S, Florack J, Pizzulli A, Giordani P, Tripodi S, Pelosi S, Matricardi PM. The impact of telemonitoring on adherence to nasal corticosteroid treatment in children with seasonal allergic rhinoconjunctivitis. Clin Exp Allergy. 2014 Oct;44(10):1246-54. doi: 10.1111/cea.12386.

    PubMed 25109375

Questions about this trial

What is this clinical trial studying?

A study testing Mobile phone alarm reminder in people with Rhinitis, Allergic and Compliance, Medication, run by National University of 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 6 inclusion and 8 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 18 Mar 2022. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compliance (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05286944, which also lists 15 linked publications.

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 18 Mar 2022.

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