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

Primary Purpose

Rhinitis, Allergic, Compliance, Medication

Status

Unknown status

Phase

Not Applicable

Locations

Malaysia

Study Type

Interventional

Intervention

Mobile phone alarm reminder

About this trial

This is an interventional other trial for Rhinitis, Allergic focused on measuring allergic rhinitis, Intranasal steroid spray, compliance, mobile alarm

Eligibility Criteria

15 Years - 66 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universiti Kebangsaan Malaysia Medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mobile daily alarm

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Compliance

Compliance was taken as 2/3rd use of INCS (20 days out of 30) = 20 x 0.38 = 7.6 g reduced weight.

Secondary Outcome Measures

Full Information

NCT ID

NCT05286944

First Posted

March 10, 2022

Last Updated

March 10, 2022

Sponsor

National University of Malaysia

Collaborators

Glenmark Pharmaceuticals S.A.

1. Study Identification

Unique Protocol Identification Number

NCT05286944

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 19, 2020 (Actual)

Primary Completion Date

June 22, 2022 (Anticipated)

Study Completion Date

June 22, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National University of Malaysia

Collaborators

Glenmark Pharmaceuticals S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis, Allergic, Compliance, Medication

Keywords

allergic rhinitis, Intranasal steroid spray, compliance, mobile alarm

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single blinded randomized controlled trial

Masking

Care ProviderInvestigatorOutcomes 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.

Allocation

Randomized

Enrollment

207 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mobile daily alarm

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Mobile phone alarm reminder

Intervention Description

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

Primary Outcome Measure Information:

Title

Compliance

Description

Compliance was taken as 2/3rd use of INCS (20 days out of 30) = 20 x 0.38 = 7.6 g reduced weight.

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

66 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aneeza K W Hamizan, MD

Organizational Affiliation

Universiti Kebangsaan Malaysia Medical Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universiti Kebangsaan Malaysia Medical center

City

Kuala Lumpur

State/Province

WP Kuala Lumpur

ZIP/Postal Code

56000

Country

Malaysia

12. IPD Sharing Statement

Plan to Share IPD

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

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