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NCT05286944 Clinical Trial

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

Rhinitis, Allergic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05286944
Other study ID # UKM PPI/111/8/JEP-2019-819
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 19, 2020
Est. completion date June 22, 2022

Study information
Verified date March 2021
Source National University of Malaysia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 207
Est. completion date June 22, 2022
Est. primary completion date June 22, 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years to 66 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Mobile phone alarm reminder
Patients are reminded to take their INCS using a mobile phone alarm set to ring daily

Locations
Country Name City State
Malaysia Universiti Kebangsaan Malaysia Medical center Kuala Lumpur WP Kuala Lumpur

Sponsors (2)
Lead Sponsor Collaborator
National University of Malaysia Glenmark Pharmaceuticals S.A.

Country where clinical trial is conducted

Malaysia, 

References & Publications (15)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Jansen A, Andersen KF, Brüning 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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(1 — View Citation

Stanaland BE. Once-daily budesonide aqueous nasal spray for allergic rhinitis: a review. Clin Ther. 2004 Apr;26(4):473-92. Review. — View Citation

Trangsrud AJ, Whitaker AL, Small RE. Intranasal corticosteroids for allergic rhinitis. Pharmacotherapy. 2002 Nov;22(11):1458-67. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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