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

March 10, 2022 updated by: National University of Malaysia
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • WP Kuala Lumpur
      • Kuala Lumpur, WP Kuala Lumpur, Malaysia, 56000
        • Universiti Kebangsaan Malaysia Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Mobile phone alarm reminder
Patients are reminded to take their INCS using a mobile phone alarm set to ring daily
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compliance
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University of Malaysia

Collaborators

Glenmark Pharmaceuticals S.A.

Investigators

  • Principal Investigator: Aneeza K W Hamizan, MD, Universiti Kebangsaan Malaysia Medical Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2020

Primary Completion (Anticipated)

June 22, 2022

Study Completion (Anticipated)

June 22, 2022

Study Registration Dates

First Submitted

March 10, 2022

First Submitted That Met QC Criteria

March 10, 2022

First Posted (Actual)

March 18, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKM PPI/111/8/JEP-2019-819

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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