NCT05286944

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2022

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2021

Enrollment Period

2.4 years

First QC Date

March 10, 2022

Last Update Submit

March 10, 2022

Conditions

Rhinitis, AllergicCompliance, Medication

Keywords

allergic rhinitisIntranasal steroid spraycompliancemobile alarm

Outcome Measures

Primary Outcomes (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.

    30 days

Study Arms (2)

Mobile daily alarm

EXPERIMENTAL

A 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.

Other: Mobile phone alarm reminder

Control

NO INTERVENTION

This 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.

Interventions

Mobile phone alarm reminderOTHER

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

Mobile daily alarm

Eligibility Criteria

Age15 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiti Kebangsaan Malaysia Medical center

Kuala Lumpur, WP Kuala Lumpur, 56000, Malaysia

Location

Related Publications (15)

  • 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.

    PMID: 22185687BACKGROUND

  • 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.

    PMID: 7488338BACKGROUND

  • 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.

    PMID: 17406040BACKGROUND

  • 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.

    PMID: 15189745BACKGROUND

  • 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.

    PMID: 29354557BACKGROUND

  • 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.

    PMID: 12432972BACKGROUND

  • 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.

    PMID: 24003381BACKGROUND

  • 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.

    PMID: 19302904BACKGROUND

  • 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.

    PMID: 17512862BACKGROUND

  • 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.

    PMID: 15461597BACKGROUND

  • 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.

    PMID: 27875376BACKGROUND

  • 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.

    PMID: 31568119BACKGROUND

  • 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.

    PMID: 11707753BACKGROUND

  • 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.

    PMID: 16114160BACKGROUND

  • 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.

    PMID: 25109375RESULT

Related Links

MeSH Terms

Conditions

Rhinitis, AllergicMedication AdherencePatient Compliance

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Aneeza K W Hamizan, MD

    Universiti Kebangsaan Malaysia Medical Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The participant will be assigned a study number based on the recruitment timeline and assigned into the pre-randomized groups. Throughout the study, the primary investigator will not know which group is assigned for the mobile phone daily alarm. A second investigator will select the group for mobile phone daily alarm and set the alarm.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 18, 2022

Study Start

January 19, 2020

Primary Completion

June 22, 2022

Study Completion

June 22, 2022

Last Updated

March 18, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

MY(1)