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

Sponsor
National University of Malaysia (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05286944
Collaborator
Glenmark Pharmaceuticals S.A. (Industry)
207
Enrollment
1
Location
2
Arms
29.1
Anticipated Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mobile phone alarm reminder
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
207 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single blinded randomized controlled trialSingle blinded randomized controlled trial
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Other
Official Title:
Mobile Phone Daily Alarm To Improve Compliance Of Intranasal Corticosteroid Among Allergic Rhinitis Patients.
Actual Study Start Date :
Jan 19, 2020
Anticipated Primary Completion Date :
Jun 22, 2022
Anticipated Study Completion Date :
Jun 22, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Compliance [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 66 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universiti Kebangsaan Malaysia Medical center Kuala Lumpur WP Kuala Lumpur Malaysia 56000

Sponsors and Collaborators

  • National University of Malaysia
  • Glenmark Pharmaceuticals S.A.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National University of Malaysia
ClinicalTrials.gov Identifier:
NCT05286944
Other Study ID Numbers:
  • UKM PPI/111/8/JEP-2019-819
First Posted:
Mar 18, 2022
Last Update Posted:
Mar 18, 2022
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National University of Malaysia
allergic rhinitis
Intranasal steroid spray
compliance
mobile alarm
Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic

Study Results

No Results Posted as of Mar 18, 2022