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

NCT ID: NCT05286944

Last Updated: 2022-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-19

Study Completion Date

2022-06-22

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rhinitis, Allergic Compliance, Medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Single blinded randomized controlled trial
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
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.

Study Groups

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Mobile daily alarm

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.

Group Type EXPERIMENTAL

Mobile phone alarm reminder

Intervention Type OTHER

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

Control

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mobile phone alarm reminder

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* • 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

Exclusion Criteria

* • 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glenmark Pharmaceuticals S.A.

INDUSTRY

Sponsor Role collaborator

National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aneeza K W Hamizan, MD

Role: PRINCIPAL_INVESTIGATOR

Universiti Kebangsaan Malaysia Medical Centre

Locations

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Universiti Kebangsaan Malaysia Medical center

Kuala Lumpur, WP Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 22185687 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7488338 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17406040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15189745 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29354557 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12432972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24003381 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19302904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17512862 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15461597 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27875376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31568119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11707753 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16114160 (View on PubMed)

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.

Reference Type RESULT
PMID: 25109375 (View on PubMed)

Other Identifiers

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UKM PPI/111/8/JEP-2019-819

Identifier Type: -

Identifier Source: org_study_id

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